Consolidated Document number 03/VBHN-BYT stipulates the registration for circulation of drugs and raw materials for drug production.

 

CIRCULAR

REGULATIONS ON THE REGISTRATION AND CIRCULATION OF MEDICINES AND RAW MATERIALS FOR MEDICINES

Circular No. 08/2022/TT-BYT dated September 5, 2022, issued by the Minister of Health, detailing the registration and circulation of medicines and raw materials for medicines, which took effect from October 20, 2022, has been amended and supplemented by:

Circular No. 55/2024/TT-BYT dated December 31, 2024, issued by the Minister of Health, amending and supplementing certain provisions on the extension of medicine registration certificates and raw materials for medicines under Circular No. 08/2022/TT-BYT dated September 5, 2022, issued by the Minister of Health regarding the registration and circulation of medicines and raw materials for medicines (hereinafter referred to as Circular No. 55/2024/TT-BYT), which took effect from January 1, 2025.

Pursuant to the Drug Law No. 105/2016/QH13 dated April 6, 2016;

Pursuant to Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government, detailing some articles and measures to implement the Law on Medicines;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department.

The Minister of Health issues this Circular detailing the registration and circulation of medicines and raw materials for medicines.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Circular details:

a) Documents, procedures for issuing, extending, changing, supplementing, and revoking registration certificates for chemical drugs, vaccines, biological products, traditional medicine drugs, and raw materials for medicines (active pharmaceutical ingredients, semi-finished traditional medicine products, excipients, capsules) for human use in Vietnam;

b) Requirements for clinical data to ensure safety and efficacy in drug registration files;

c) Criteria for determining cases exempted from trials, exempted from some phases of clinical trials in Vietnam, and drugs requiring phase 4 clinical trials;

d) Principles of organization and operation of experts reviewing applications for issuing, extending, changing, and supplementing registration certificates for medicines and raw materials for medicines;

đ) Principles of organization and operation of experts reviewing applications for import permits for medicines without registration certificates in cases specified in point a, Clause 43, Article 5 of Government Decree No. 155/2018/NĐ-CP dated November 12, 2018, amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health (hereinafter referred to as Decree No. 155/2018/NĐ-CP);

e) Principles of organization and operation of the Advisory Council for issuing registration certificates for medicines and raw materials for medicines (hereinafter referred to as the Council);

g) Procedures for reviewing applications for issuing, extending, changing, and supplementing registration certificates for medicines and raw materials for medicines; procedures for reviewing applications for importing medicines without registration certificates.

2. This Circular does not apply compulsorily to cases specified in point a, b, Clause 2, Article 54 of the Law on Medicines and semi-finished traditional medicine products produced by the manufacturing facility itself for producing finished traditional medicine products as specified in point e, Clause 1, Article 93 of Government Decree No. 54/2017/NĐ-CP dated May 8, 2017, detailing some articles and measures to implement the Law on Medicines (hereinafter referred to as Decree No. 54/2017/NĐ-CP), except in cases where the applicant voluntarily applies.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. ASEAN Common Technical Document (ACTD) is a set of guidelines for drug registration files meeting the common technical requirements of the Association of Southeast Asian Nations (ASEAN) as stipulated in Appendix I attached hereto.

2. ICH Common Technical Document (ICH-CTD) is a common format for drug registration files used for human use by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

3. Major Change refers to changes that significantly and directly affect the quality, safety, and efficacy of the drug, as defined in Appendix II attached hereto.

4. Minor Change refers to changes that do not affect or have very little impact on the efficacy, quality, and safety of the drug, as defined in Appendix II attached hereto.

5. Medicine and Raw Material Registration Applicant is the entity named in the application for issuing, extending, changing, and supplementing registration certificates for medicines and raw materials for medicines.

6. Medicine Manufacturing Facility is the facility carrying out one, several stages, or the entire production process or performing the release of batches of medicines.

7. Raw Material Manufacturing Facility is the facility producing raw materials for finished medicines or performing the release of batches of raw materials for medicines.

8. Drug Product Certificate (CPP) (Criminal Procedure Code) is a certificate issued according to the World Health Organization's (WHO) system for certifying the quality of marketed pharmaceutical products internationally.

9. European Medicines Agency (EMA) and Strict Regulatory Authority (SRA - Stringent Regulatory Authorities) includes:

a) European Medicines Agency (EMA);

b) Strict Regulatory Authority (SRA - Stringent Regulatory Authorities): regulatory authorities classified by the World Health Organization (WHO) as SRA, including:

- Pre-October 23, 2015 ICH members, including: US Food and Drug Administration (US-FDA), European Union (EU) Medicines Agencies, United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA), Japan Pharmaceutical and Medical Devices Agency (PMDA);

- Pre-October 23, 2015 ICH observers, including: European Free Trade Association (EFTA) with representatives from Swissmedic and Health Canada;

- Pre-October 23, 2015 ICH associated members with mutual recognition agreements, including: Australia, New Zealand, Liechtenstein, and Norway.

10. Product License Holder / Marketing Authorization Holder is the entity holding the product license recorded on the Drug Product Certificate (CPP) issued according to WHO's model.

11. Semi-finished Traditional Medicine Products are raw materials for producing traditional medicine drugs in the form of extracts, powders, decoctions, essential oils, resins, gums, jellies.

Article 3. Responsibilities of the drug registration entity

1. Shall bear full responsibility under the law for the accuracy, legality, and truthfulness of all documents in the registration dossier. Cooperate with the production entity, domestic and foreign competent authorities in responding to the Drug Administration's requests to verify the authenticity of relevant legal documents in the drug registration dossier.

2. Implement changes and supplements according to Clause 4, Article 27, Clause 3, Article 30, Clause 3, Article 32, and Article 38 of this Circular during the validity period of the drug marketing authorization certificate.

3. Shall be responsible for changing and supplementing the content of the label and instructions for use of the drug in accordance with the content of the Drug Administration's update request document during the validity period of the drug marketing authorization certificate without having to submit a change or supplement registration dossier.

4. Ensure the quality, safety, and efficacy of drugs and drug raw materials consistent with the registration dossier.

5. Notify the Drug Administration in writing within thirty days from the date of the decision to revoke the marketing authorization certificate at any country worldwide for drugs and drug raw materials that have been granted a marketing authorization certificate in Vietnam still in effect, specifying the reasons for revocation.

6. Closely cooperate with the drug manufacturing entity to conduct research or provide additional information related to the registered drug when there is information or evidence concerning the safety and efficacy of the drug during circulation, as required by the competent authority.

7. Cooperate with the production, import, and distribution entities to monitor, collect, compile, evaluate, and report to the National Center for Medicines Information and Adverse Drug Reaction Monitoring (National DI & ADR Center) on post-vaccination reactions and adverse drug reactions in accordance with Clause 5, Article 77 of the Medicine Law, national pharmacovigilance guidelines issued by the Ministry of Health, and related regulations.

8. Ensure the maintenance of business conditions for the drug registration entity during the validity period of the drug marketing authorization certificate. In case of no longer meeting the operational conditions, the registration entity must undertake to change the registration entity according to Clause 4, Article 27, Clause 3, Article 30, Clause 3, Article 32, and Article 38 of this Circular within thirty days from the date the registration entity no longer meets the operational conditions.

9. Shall be responsible for intellectual property issues related to drugs and drug raw materials registered for circulation in Vietnam.

10. Coordinate with the production entity to update the quality standards of drugs and drug raw materials in accordance with Circular No. 11/2018/TT-BYT dated May 4, 2018, of the Minister of Health on drug quality and drug raw material quality (hereinafter referred to as Circular No. 11/2018/TT-BYT) and Circular No. 38/2021/TT-BYT dated December 31, 2021, of the Minister of Health on herbal medicine quality, traditional medicine ingredients, and traditional medicine (hereinafter referred to as Circular No. 38/2021/TT-BYT).

11. Implement the risk management plan approved in the application dossier for granting or extending the marketing authorization certificate for vaccines.

12. Shall be responsible in accordance with Clause 2, Article 57 of the Medicine Law and the provisions of this Article for drugs and drug raw materials registered by the entity from the date the Drug Administration signs the letter approving the change of the registration entity, including those drugs and drug raw materials already in circulation before the Drug Administration issued the letter approving the change of the registration entity.

13. Cooperate with the production entity to provide one of the documents or materials specified in Clause 11, Article 22 of this Circular to the competent authority upon request.

14. Shall be responsible in accordance with this Circular and other relevant laws.

Article 4. Responsibilities of Pharmaceutical Product Manufacturing Facilities

1. Must produce pharmaceutical products and drug raw materials at the correct facility with a production permit/drug business qualification certificate for manufacturing pharmaceutical products and drug raw materials issued by the competent authority.

2. Shall be fully responsible under the law for the accuracy, legality, and truthfulness of all documents related to pharmaceutical products and drug raw materials provided by the pharmaceutical product and drug raw material manufacturing facility to the registration facility for registration for circulation in Vietnam.

3. Cooperate with the pharmaceutical product and drug raw material registration facility:

a) Implement the provisions of Clause 2, 3, and 4 of Article 3 of this Circular;

b) Fulfill inspection and evaluation requirements of the manufacturing facility when requested by the competent authority.

4. Propose the revocation of the registration certificate for circulation of pharmaceutical products and drug raw materials produced by the manufacturing facility in cases where the quality, safety, and efficacy of the pharmaceutical products and drug raw materials affect the health of users according to Form 1/TT attached to this Circular.

5. Ensure the operating conditions of the manufacturing facility during the validity period of the registration certificate for circulation of pharmaceutical products and drug raw materials.

6. In case the pharmaceutical product and drug raw material registration facility does not meet the operating conditions as notified by the competent authority, the manufacturing facility may change the registration facility of the pharmaceutical products and drug raw materials within thirty days from the date of receipt of the notification document.

7. Update the quality standards of pharmaceutical products and drug raw materials in accordance with Circular No. 11/2018/TT-BYT and Circular No. 38/2021/TT-BYT.

8. Shall be responsible for evaluating and ensuring that the drug raw material manufacturing facility complies with good manufacturing practices for drug raw materials, and provide one of the documents or materials specified in Clause 11 of Article 22 of this Circular to the competent authority upon request.

Article 5. Provisions on Monitoring, Evaluation of Safety and Efficacy Reporting

1. Drug business facilities and medical examination and treatment facilities must implement monitoring, supervision, collection, consolidation, evaluation, and reporting to the competent authority information on post-vaccination reactions and adverse drug reactions as stipulated in Article 77 and Article 78 of the Medicine Law, national pharmacovigilance guidelines issued by the Ministry of Health, and relevant regulations.

2. The pharmaceutical product registration facility must report monitoring and evaluation of the safety and efficacy of pharmaceutical products as stipulated in Clause 2 of Article 8 of this Circular according to Form 2A/TT (for pharmaceutical products) or Form 2B/TT (for vaccines):

a) Annually every six months during the validity period of the registration certificate for circulation sent to the National Center for DI & ADR;

b) [2] (Repealed)

3. Medical examination and treatment facilities using pharmaceutical products must report the situation of pharmaceutical product usage according to Form 2C/TT attached to this Circular annually every six months during the validity period of the registration certificate for circulation of pharmaceutical products as stipulated in Clause 2 of Article 8 of this Circular and send it to the National Center for DI & ADR.

4. Annually every six months, the National Center for DI & ADR shall be responsible for consolidating, evaluating, and sending reports to the Drug Administration Department.

Article 6. Language, form of application dossier, number of application dossiers, documents.

1. Language used in the registration dossier

The drug registration dossier must be written in Vietnamese or English. Specifically, the drug usage instructions and product characteristics summary must be written in Vietnamese.

2. The drug registration dossier must be prepared on A4 paper size, securely bound. The dossier must have a cover page (Model 3/TT) arranged according to the correct sequence of the table of contents (Model 4/TT), with clear separation between sections. Each section must be numbered sequentially and confirmed with a stamp from the registering entity or the drug manufacturing entity at the first page of each section throughout the entire dossier (accepting stamps from representative offices for foreign drugs). This provision does not apply to online submitted dossiers.

The following documents must be compiled separately and accompanied by one registration form:

a) Equivalent bioequivalence research documents;

b) Preclinical and clinical documents;

c) Documents assessing compliance with Good Manufacturing Practices (GMP) as stipulated in Articles 95 and 98 of Decree No. 54/2017/NĐ-CP and Points 53 of Article 4 and Point 51 of Article 5 of Decree No. 155/2018/NĐ-CP for foreign drug manufacturing entities when registering for circulation in Vietnam.

3. Drugs may be registered in the same dossier if they share the following common factors: drug name; dosage form; route of administration; drug quality standards; manufacturer's name and address; identical formulation, including: identical active ingredient content based on the unit dose for solid dosage forms with divided doses; identical concentration or content of the active ingredient for solid dosage forms without divided doses, liquid, or semi-solid forms; identical concentration or content of the active ingredient and direct contact packaging material for injectable and infusion forms.

4. Number of documents required to be submitted in the application dossier for issuance, extension of the registration certificate, specifically as follows:

a) One complete set of dossier as prescribed in Clauses 1, 2, 3, and 5 of Article 27 of this Circular for chemical drugs, vaccines, and biological products, and as prescribed in Clauses 1 and 2 of Article 30 and Clauses 1 and 2 of Article 32 of this Circular for herbal drugs and drug raw materials;

b) One complete copy of the dossier for vaccines; two copies of the documents including the registration form, quality standards, and testing methods for drugs and drug raw materials for other cases;

c) Two sets of drug label samples and drug usage instructions expected to be circulated, stamped with confirmation from the registering entity (accepting stamps from representative offices for foreign drugs) or the manufacturing entity. Drug labels and drug raw material labels should be affixed and designed on appropriate paper sizes but not smaller than A4. In the case of online submission, the entity only needs to submit one set of drug label samples and drug usage instructions.

5. Number of documents required to be submitted in the application dossier for changes and additions to the registration certificate:

a) One complete set of documents as prescribed in Clause 4 of Article 27 of this Circular for chemical drugs, vaccines, and biological products, and Clause 3 of Article 30 and Clause 3 of Article 32 of this Circular for herbal drugs and drug raw materials;

b) Two sets of drug label samples and drug usage instructions proposed for change in the case of changing labels or usage instructions, stamped with confirmation from the registering entity (accepting stamps from representative offices for foreign drugs) or the manufacturing entity. Drug labels and drug raw material labels should be affixed and designed on appropriate paper sizes but not smaller than A4. In the case of online submission, the entity only needs to submit one set of drug label samples and drug usage instructions.

6. Provisions on the application of online dossiers:

a) Number and components of the dossier: One complete set of dossier as prescribed in this Circular (excluding the cover page); For parts of the dossier requiring data confidentiality, the entity shall directly submit them to the Drug Administration of Vietnam in accordance with Circular No. 05/2010/TT-BYT dated March 1, 2010, issued by the Minister of Health guiding data confidentiality in drug registration (hereinafter referred to as Circular No. 05/2010/TT-BYT);

b) The process of submitting online dossiers shall be implemented according to the announcement of the Ministry of Health. From the date the full online submission regulation takes effect, the registering entity shall submit the dossier online in accordance with the provisions of point a of this clause. In cases where a paper version of the registration dossier is requested for review and comparison, the Drug Administration of Vietnam will issue a notification.

Article 7. Registration Fees for Medicines and Active Pharmaceutical Ingredients

The entity registering medicines and active pharmaceutical ingredients must pay registration fees related to the registration of medicines and active pharmaceutical ingredients in accordance with current laws on fees and charges.

Article 8. Validity, Symbol of Medicine Circulation Registration Certificate, Active Pharmaceutical Ingredients, and Time Limit for Submitting Extension Registration Applications; Quantity of Circulation Registration Certificates for Medicines with the Same Active Ingredient or Herbal Component, Formulation, Route of Administration, Dosage, or Concentration in a Single Unit Dose

1. The validity period of the medicine circulation registration certificate, active pharmaceutical ingredient is five (5) years from the date of issuance or extension, except in cases stipulated in Clause 2 of this Article.

2.[3] The validity period of the medicine circulation registration certificate is three (3) years from the date of issuance or extension for the following medicines:

a) New medicines, vaccines being issued a circulation registration certificate for the first time, reference biological products, biosimilar products being issued a circulation registration certificate for the first time in Vietnam;

b) Medicines with the same active ingredient, concentration, dosage, formulation as new medicines that have not been issued a circulation registration certificate with a validity period of five (5) years;

c) Cases requiring continued monitoring of safety and efficacy according to the advisory opinion of the Council;

d) Medicines falling under points a, b, and c of this clause but at the time of submitting the application for extending the circulation registration certificate, there is no safety and efficacy report due to non-circulation or there is a safety and efficacy report but the quantity of medicine used, the number of patients, and the duration of use are limited according to the Council's opinion or there is a recommendation from healthcare facilities to continue monitoring safety and efficacy.

2a.[4] The medicine circulation registration certificate, active pharmaceutical ingredient when its validity period expires but has been accepted by the Drug Administration Department for an application to extend the circulation registration certificate in accordance with regulations shall continue to be used until it is extended or until the Drug Administration Department issues a notice not to extend or temporarily suspend the use of the circulation registration certificate due to the discovery of risks to users or suspicion of falsified legal documents.

3. Each medicine, active pharmaceutical ingredient granted a circulation registration certificate will have a registration number structured as specified in Appendix VI attached to this Circular.

4. Time limit for submitting an extension registration application: Within twelve (12) months before the expiration of the validity period of the circulation registration certificate, the entity registering must submit an application to extend the circulation registration certificate.

5. In case of administrative file changes in the extension application, within twelve (12) months from the date of issuance of the Decision on extending the circulation registration certificate, the entity must implement the approved changes in the extension application.

6. The quantity of circulation registration certificates for medicines produced by the same manufacturer with the same active ingredient or herbal component; formulation; route of administration; dosage or concentration in a single unit dose: One circulation registration certificate with the trade name and one circulation registration certificate with the international nonproprietary name. This provision does not apply to contract-manufactured medicines and medicines produced solely for export.

Article 9. Criteria for Classification and Cases of Announcing Original Brand Name Drugs, Reference Biological Products

1. Criteria for Classifying Original Brand Name Drugs, Reference Biological Products

a) Medicines granted a circulation registration certificate in Vietnam are classified as original brand name drugs, reference biological products if they meet the following criteria simultaneously:

- Having complete clinical data on safety and efficacy as stipulated in Article 13 of this Circular;

Specifically, reference biological products must have complete files and data on quality, preclinical, and clinical development as if developing a biological product from scratch, not developed as a biosimilar;

- Being licensed for circulation by one of the regulatory authorities specified in Clause 9 of Article 2 of this Circular, except for newly manufactured medicines in Vietnam.

b) For medicines that have been announced as original brand name drugs, reference biological products by the Ministry of Health and subsequently contracted out or transferred technology for production of one, several, or all stages at a medicine manufacturing facility in Vietnam, these medicines must ensure that both the original brand name drug, reference biological product and the contracted-out or technology-transferred production in Vietnam meet the following criteria simultaneously:

- Same formulation process;

- Same production process;

- Same quality standards for raw materials;

- Same quality standards for finished medicines;

In case of changes to any of the criteria in this point or other changes related to the quality of the medicine, such changes must be approved by the drug regulatory authority of the producing country or the regulatory authority specified in Clause 9 of Article 2 of this Circular that has licensed the circulation of the medicine, or the entity registering must provide data proving that the medicine produced in Vietnam is equivalent in quality to the original brand name drug, reference biological product before contracting out or transferring technology.

c) Medicines that have been announced as original brand name drugs, reference biological products and have changed the manufacturing facility, the new circulation registration certificate granted to the changed manufacturing facility will also be classified as an original brand name drug, reference biological product based on a written request from the entity registering if they meet the following criteria simultaneously:

- Being licensed for circulation by one of the regulatory authorities specified in Clause 9 of Article 2 of this Circular;

- Meeting the criteria stipulated in Point b of Clause 1 of this Article simultaneously.

In case of changes to any of the criteria in Point b of Clause 1 of this Article or other changes related to the quality of the medicine, such changes must be approved by the drug regulatory authority of the producing country or the regulatory authority specified in Clause 9 of Article 2 of this Circular that has licensed the circulation of the medicine, or the entity registering must provide data proving that the medicine produced at the new facility is equivalent in quality to the original brand name drug, reference biological product before changing the manufacturing facility.

2. Cases where medicines are classified as original brand name drugs, reference biological products:

a) Medicines that have been announced by the Ministry of Health as original brand-name drugs or reference biological products, which are entirely produced in a country with the regulatory authority specified in Clause 9, Article 2 of this Circular, shall continue to be classified as original brand-name drugs or reference biological products if they fall under any of the following circumstances:

- The medicine has a registration certificate for circulation that remains valid, has been extended, or has been amended or supplemented and does not fall within the provisions of point b, Clause 2, Article 55 of the Medicine Law. The registering entity is not required to submit an application for classification as an original brand-name drug or reference biological product;

- A new registration certificate for circulation is issued for the medicine according to the re-registration procedure prescribed in Circular No. 44/2014/TT-BYT dated November 25, 2014, of the Minister of Health on the registration of medicines (hereinafter referred to as Circular No. 44/2014/TT-BYT), and the medicine has the same formulation, production process, raw material quality standards, and finished product quality standards as the original brand-name drug or reference biological product that has been announced, or it has changes related to the above content that have been approved by the Drug Administration of Vietnam or the competent authority of the country where the product is manufactured. The registering entity must submit an updated classification application for original brand-name drugs or reference biological products in accordance with Appendix II attached to this Circular;

- The medicine changes its manufacturing facility and obtains a new registration certificate for circulation that complies with the provisions of point c, Clause 1 of this Article. The registering entity must submit an updated classification application for original brand-name drugs or reference biological products in accordance with Appendix II attached to this Circular.

b) Medicines that have been announced by the Ministry of Health as original brand-name drugs or reference biological products, which are manufactured outside the country but are not entirely produced in a country with the regulatory authority specified in Clause 9, Article 2 of this Circular, but are permitted to circulate in a country with the regulatory authority listed in Clause 9, Article 2 of this Circular, shall continue to be classified as original brand-name drugs or reference biological products if they fall under any of the following circumstances:

- The medicine has a registration certificate for circulation that remains valid, has been extended, or has been amended or supplemented and does not fall within the provisions of point b, Clause 2, Article 55 of the Medicine Law;

- A new registration certificate for circulation is issued for the medicine according to the re-registration procedure prescribed in Circular No. 44/2014/TT-BYT, and the medicine has the same formulation, production process, raw material quality standards, and finished product quality standards as the original brand-name drug or reference biological product that has been announced, or it has changes related to the above content that have been approved by the competent authority of Vietnam or the country where the product is manufactured;

- The medicine changes its manufacturing facility and obtains a new registration certificate for circulation that complies with the provisions of point c, Clause 1 of this Article;

The registering entity must submit an updated classification application for original brand-name drugs or reference biological products for the three cases above in accordance with Appendix II attached to this Circular.

c) Medicines that have been announced by the Ministry of Health as original brand-name drugs or reference biological products, which are entirely produced in Vietnam or some stages of production are carried out in Vietnam and the remaining production stages are entirely carried out in a country with the regulatory authority specified in Clause 9, Article 2 of this Circular, shall continue to be classified as original brand-name drugs or reference biological products if they fall under any of the following circumstances:

- The medicine has a registration certificate for circulation that remains valid, has been extended, or has been amended or supplemented and does not fall within the provisions of point b, Clause 2, Article 55 of the Medicine Law. The registering entity is not required to submit an application for classification as an original brand-name drug or reference biological product;

- A new registration certificate for circulation is issued for the medicine according to the re-registration procedure prescribed in Circular No. 44/2014/TT-BYT, and the medicine has the same formulation, production process, raw material quality standards, and finished product quality standards as the original brand-name drug or reference biological product that has been announced, or it has changes related to the above content that have been approved by the competent authority of Vietnam or the country where the product is manufactured. The registering entity must submit an updated classification application for original brand-name drugs or reference biological products in accordance with Appendix II attached to this Circular;

- The medicine changes its manufacturing facility and obtains a new registration certificate for circulation that complies with the provisions of point c, Clause 1 of this Article. The registering entity must submit an updated classification application for original brand-name drugs or reference biological products in accordance with Appendix II attached to this Circular.

d) Medicines that have been announced by the Ministry of Health as original brand-name drugs or reference biological products, which are partially produced in Vietnam and the remaining production stages are not entirely carried out in a country with the regulatory authority specified in Clause 9, Article 2 of this Circular, but are permitted to circulate in a country with the regulatory authority specified in Clause 9, Article 2 of this Circular, shall continue to be classified as original brand-name drugs or reference biological products if they fall under any of the following circumstances:

- The medicine has a registration certificate for circulation that remains valid, has been extended, or has been amended or supplemented and does not fall within the provisions of point b, Clause 2, Article 55 of the Medicine Law;

- A new registration certificate for circulation is issued for the medicine according to the re-registration procedure prescribed in Circular No. 44/2014/TT-BYT, and the medicine has the same formulation, production process, raw material quality standards, and finished product quality standards as the original brand-name drug or reference biological product that has been announced, or it has changes related to the above content that have been approved by the competent authority of Vietnam or the country where the product is manufactured;

- The medicine changes its manufacturing facility and obtains a new registration certificate for circulation that complies with the provisions of point c, Clause 1 of this Article;

The registering entity must submit an updated classification application for original brand-name drugs or reference biological products for the three cases above in accordance with Appendix II attached to this Circular.

đ) Medicines that have been announced by the Ministry of Health as original brand-name drugs or reference biological products, which are entirely produced in a country with the regulatory authority specified in Clause 9, Article 2 of this Circular, and are processed or transferred technology for production in Vietnam, then the medicine processed or transferred technology for production in Vietnam, either partially, some stages, or all stages of production, and issued a new registration certificate for circulation, shall continue to be classified as original brand-name drugs or reference biological products if they comply with the provisions of point b, Clause 1 of this Article. The registering entity that processes or transfers technology for production in Vietnam must submit an updated classification application for original brand-name drugs or reference biological products in accordance with Appendix II attached to this Circular;

e) Medicines that have been announced by the Ministry of Health as original brand-name drugs or reference biological products, which are not entirely produced in a country with the regulatory authority specified in Clause 9, Article 2 of this Circular, but are permitted to circulate in a country with the regulatory authority specified in Clause 9, Article 2 of this Circular, and are processed or transferred technology for production in Vietnam, then the medicine processed or transferred technology for production in Vietnam, either partially, some stages, or all stages of production, and issued a new registration certificate for circulation, shall continue to be classified as original brand-name drugs or reference biological products if they comply with the provisions of point b, Clause 1 of this Article. The registering entity that processes or transfers technology for production in Vietnam must submit an updated classification application for original brand-name drugs or reference biological products in accordance with Appendix II attached to this Circular;

g) Medicines that have not been announced as original drugs or reference biological products by the Ministry of Health shall be classified as original drugs or reference biological products if they meet the requirements set forth in point a, Clause 1 of this Article. The registration entity shall submit an application to update the classification of original drugs or reference biological products in accordance with Appendix II attached to this Circular.

Article 10. Criteria for classifying medicines with proven bioequivalence

A medicine registered for circulation in Vietnam shall be classified as a medicine with proven bioequivalence when it has a bioequivalence report meeting the Ministry of Health's regulations on medicines required to undergo bioequivalence testing and the requirements for filing bioequivalence study data reports in the registration for circulation of medicines in Vietnam.

Article 11. Data confidentiality requirements for drug registration files

If a drug registration entity requests data confidentiality for the drug registration file, it shall comply with the provisions of Circular No. 05/2010/TT-BYT and must clearly state the request in the registration form according to Model 5/TT issued together with this Circular.

Article 12. Provisions on verifying the authenticity of legal documents

1. Before issuing a registration certificate for circulation, the Drug Administration shall verify the legal documents submitted in the drug registration dossier in the following specific cases:

a) For Certificates of Pharmaceutical Product (CPP):

- CPP showing signs of erasure or alteration of information;

- CPP in the drug registration dossier of production establishments or registration entities that have been penalized by competent authorities in Vietnam for administrative violations related to providing false technical dossier information not based on actual research or production of the establishment, which is listed on the Drug Administration’s website. The verification period for CPPs is two years from the end date of the suspension of acceptance of registration applications and extension of registration certificates;

- CPP of a medicine produced by a first-time registration entity in Vietnam, except where multiple entities participate in production and at least one entity has already obtained a registration certificate for circulation in Vietnam;

- Electronic CPP provided through self-searching from the website or English-language database of the issuing authority or competent authority of foreign countries, but not accessible via the direct link provided by the entity in the dossier;

- CPP without the stamp of the competent authority of the issuing country;

- Cases requested by the Council to conduct verification.

b) For legal documents related to the registration entity and production establishment: Verification of authenticity applies to the legal documents of first-time registration entities and production establishments registering in Vietnam.

2. For medicines that have already been granted a registration certificate for circulation, the Drug Administration shall verify the authenticity of legal documents upon receiving written information, official email, or public media reports reflecting issues regarding licensing and circulation of medicines in the home country that need clarification or information about non-compliance with operating conditions of pharmaceutical production and foreign registration establishments.

3. The verification of the authenticity of CPPs and legal documents submitted in the drug registration dossier shall be conducted in writing or through official emails in the following manner:

a) Verification of the authenticity of legal documents related to consular legalization: The Drug Administration shall cooperate with the Consular Department of the Ministry of Foreign Affairs or diplomatic agencies responsible for consular legalization in Vietnam to verify the authority and information related to the consular legalization of foreign legal documents for use in Vietnam as stipulated in items 2, 3 of point a and point b, Clause 1 of this Article;

b) Verification of the content of legal documents: The Drug Administration shall cooperate with the issuing authorities of the legal documents to verify the information stated in these documents as stipulated in item 1, 4, 5, 6 of point a, Clause 1 of this Article.

4. The verification of the authenticity of legal documents as prescribed in Clause 1 of this Article shall be carried out concurrently with the review process of the drug registration dossier within the time limit specified in Clause 5 of Article 56 of the Medicine Law. A medicine will only be considered for issuance of a registration certificate for circulation if the verification results meet the requirements of the competent authorities as stipulated in Clause 3 of this Article.

The request for verification of legal documents shall be sent simultaneously to the drug registration entity. Within six months from the date the Drug Administration conducts verification, if no verification result is received from the competent authority, the Drug Administration shall report to the Council on the status of verification of legal documents and propose not to issue a registration certificate for circulation.

Chapter II

REQUIREMENTS FOR CLINICAL DATA TO ENSURE SAFETY, EFFECTIVENESS AND CRITERIA FOR DETERMINING CASES OF EXEMPTION FROM CLINICAL TRIALS, EXEMPTION FROM SOME STAGES OF CLINICAL TRIALS, AND REQUIREMENTS FOR CONDUCTING PHASE 4 CLINICAL TRIALS IN VIETNAM

Article 13. Provisions on clinical data in the registration dossier for the circulation of chemical drugs, vaccines, and biological products.

1. Requirements for clinical data to ensure the safety and efficacy of new chemical drugs, vaccines, and biological products in the registration dossier for circulation.

a) Clinical studies of the drug and data in the clinical dossier must be consistent with the guidelines of ICH, the Ministry of Health of Vietnam, or other guidelines recognized by Vietnam (including: guidelines of international organizations that Vietnam is a member of, guidelines of regulatory authorities specified in Clause 9, Article 2 of this Circular), except in cases provided for in Clause 3 of this Article.

b) Clinical data (except for similar biological products to reference biological products already granted registration certificates for circulation in Vietnam) must contain sufficient information to analyze and explain the impact of Asian ethnic factors related to the safety and efficacy of the drug for extrapolating clinical data on the Asian population according to the guidelines specified in Point a of this Clause or must have bridging study data according to ICH-E5 guidelines for extrapolating clinical data on the Asian population.

c) Vaccines that have been granted permission for circulation and comply with the provisions of Point d, Clause 4, Article 22 of this Circular and have complete clinical data on safety and efficacy as stipulated in Points a and b of this Clause but have not been produced entirely on production lines in countries specified in Clause 9, Article 2 of this Circular must have clinical data related to evaluating safety and immunogenicity in the target population in Vietnam before being granted permission for circulation.

d) Vaccines that have complete clinical data for evaluating safety and efficacy as stipulated in Points a and b of this Clause but do not meet the requirements of Point d, Clause 4, Article 22 of this Circular must have clinical data related to evaluating safety and immunogenicity in the target population in Vietnam before being granted permission for circulation.

2. Chemical drugs with different active ingredient content or concentration, route of administration, method of administration, dosage, indication, patient population, or formulation affecting the pharmacokinetics of the drug compared to the originator drug already granted permission for circulation in Vietnam or compared to a drug granted permission for circulation by one of the regulatory authorities specified in Clause 9, Article 2 of this Circular where the originator drug has not yet been granted permission for circulation in Vietnam must have clinical data as stipulated in Points a and b of Clause 1 and Clause 3 of this Article before being granted permission for circulation.

3. In cases where research was conducted prior to the issuance of regulations and guidelines on drug development research as stipulated in Point a, Clause 1 of this Article, the data from such research may be considered for acceptance for evaluation.

Article 14. Requirements for clinical data to ensure safety and efficacy in the registration dossier for circulation of drugs with new combinations of active ingredients and similar biological products.

1. Drugs with new combinations of active ingredients must have complete clinical data in accordance with the guidelines of the US FDA, EMA, or WHO on the clinical development of fixed-dose combination drugs as specified in Appendix IV issued together with this Circular.

2. Similar biological products must have complete clinical data in accordance with the guidelines for the development of similar biological products issued by the Ministry of Health of Vietnam or the guidelines of WHO. Guidelines of the US FDA, EMA, and guidelines developed based on these guidelines are accepted. The WHO, US FDA, and EMA guidelines as specified in Appendix IV issued together with this Circular.

Article 15. Requirements for clinical data to ensure safety and efficacy in the registration dossier for new chemical drugs that are not originator brand drugs

Clause 1. For drugs approved for circulation in the country of origin as prescription drugs (except for drugs produced in Vietnam) and have at least one similar drug (same active ingredient, concentration, dosage form, route of administration) approved for circulation by one of the management agencies specified in Clause 9, Article 2 of this Circular must have clinical data meeting one of the following cases:

Point a. There is clinical data of the same similar drug permitted for use by the owner. The clinical data of the similar drug must comply with the provisions of Article 13 of this Circular;

Point b. There is clinical data compiled from published research works in medical literature and data on bioequivalence studies (except for cases where the drug does not require bioequivalence testing according to the regulations of the competent authority of the country of origin).

Clause 2. For drugs classified as over-the-counter drugs by the country of origin (except for drugs produced in Vietnam and the case stipulated in Clause 3 of this Article) and have at least one similar drug (same active ingredient, concentration, dosage form, route of administration) approved for circulation by at least one country in the world must have clinical data meeting one of the following cases:

Point a. There is clinical data of the same similar drug permitted for use by the owner. The clinical data of the similar drug must comply with the provisions of Article 13 of this Circular;

Point b. There is clinical data compiled from published research works in medical literature and data on bioequivalence studies (except for cases where the drug does not require bioequivalence testing according to the regulations of the competent authority of the country of origin).

Clause 3. For drugs approved for circulation and classified as over-the-counter drugs by at least one of the management agencies specified in Clause 9, Article 2 of this Circular, there must be explanatory documents and evidence proving the use of the active ingredients in the drug (regarding indications, dosage, route of administration, target population) has been clearly recorded in the Vietnamese National Pharmacopoeia, Vietnamese Pharmacopoeia, Drug Books, or other documents accepted by one of the management agencies specified in Clause 9, Article 2 of this Circular.

Article 16. Requirements for clinical data for drugs that have been granted registration certificates for circulation in Vietnam but have changes or additions related to clinical data compared to the approved drug registration dossier

Chemical drugs, vaccines, biological products, herbal medicines that have been granted registration certificates for circulation in Vietnam and have changes or additions related to clinical data compared to the approved drug registration dossier, the registrant must supplement clinical data in accordance with the provisions set out in Appendix II attached to this Circular.

Article 17. Criteria for determining exemption from one or several phases of clinical trials for new chemical drugs, vaccines, biological products before granting approval for circulation

Drugs that do not meet the requirements of Article 13 of this Circular shall be exempted from one or several phases of clinical trials (including reduction of clinical data) based on the opinion of the Advisory Board if they fall under one of the following cases:

Clause 1. Drugs that meet urgent needs for national defense, security, disease prevention and control, disaster relief, and have no alternative drugs available on the market.

Clause 2. Drugs that have been approved for circulation by at least one of the management agencies specified in Clause 9, Article 2 of this Circular based on reduced clinical trial dossiers according to the regulations of these agencies.

Clause 3. Drugs used to treat rare diseases; serious illnesses.

Clause 4. Vaccines, biological products produced in Vietnam through technology transfer of one, some, or all stages of the finished product manufacturing process, where the vaccines, biological products before technology transfer have clinical data complying with the provisions of Clause 1, Article 13 and Article 14 of this Circular.

Article 18. Requirements for clinical data in the registration dossier for circulation of herbal drugs

1. Clinical data requirements to ensure safety and efficacy in the registration dossier for new herbal drugs

a) Clinical studies of the drug, clinical data in the dossier must be consistent with the Preclinical and Clinical Research Guidelines for Herbal Drugs issued by the Ministry of Health or other organizations recognized by Vietnam, including: Research guidelines for evaluating the safety and efficacy of herbal medicines or as prescribed by Clause 9, Article 2 of this Circular. In cases where research was conducted before the regulations and guidelines on drug development were established, the research data may be accepted for evaluation;

b) Herbal drugs with clinical data cited from the following sources are accepted as clinical data to assess the safety and efficacy of the drug:

- Relevant monographs on the safety and efficacy of the drug mentioned in the pharmacopoeias and pharmaceutical compendia of Vietnam or other countries;

- Review articles on the safety and efficacy of the drug published in journals listed in the Science Citation Index (SCI) and clinical data compiled from other peer-reviewed publications;

- Reports on the assessment of the safety and efficacy of national, ministry-level, or provincial science and technology projects that have been approved.

2. Herbal drugs are not required to submit clinical data as stipulated in Clause 1 of this Article if they meet any of the following conditions:

a) The herbal drug has the same active ingredients, quantity of herbal materials, indications, route of administration, and dosage form as another herbal drug that has already obtained a registration certificate for circulation (including cases where the registration certificate has expired), except for traditional drugs and those without indications for diseases listed in the Disease List issued by the Minister of Health pursuant to Point b, Clause 1, Article 89 of the Medicine Law;

b) In cases where the herbal drug has the same active ingredients, quantity of herbal materials, indications, route of administration, and dosage form as a newly approved herbal drug for circulation in Vietnam based on complete clinical data as stipulated in Clause 1 of this Article and does not include additional indications for diseases listed in the Disease List issued by the Minister of Health pursuant to Point b, Clause 1, Article 89 of the Medicine Law, it may be considered for approval for circulation when the other herbal drug has already been approved for circulation, extended with a registration certificate validity period of five years.

Article 19. Criteria for determining cases exempted from one or several phases of clinical trials of herbal drugs before granting circulation permission

Herbal drugs that do not meet the provisions of Article 18 of this Circular shall be subject to consideration by the Minister of Health for exemption from one or several phases of clinical trials (including reduction of clinical data) based on the advisory opinion of the Council in any of the following cases:

Clause 1. Drugs that meet urgent needs for national defense, security, disease prevention and control, disaster relief, and have no alternative drugs available on the market.

2. The drug has been approved for circulation by at least one of the reference regulatory authorities specified in Clause 9, Article 2 of this Circular based on a reduced clinical dossier according to the regulations of these authorities.

3. The drug is indicated for diseases listed in the Disease List issued by the Minister of Health pursuant to Point b, Clause 1, Article 89 of the Medicine Law but does not fall under the exemption from clinical trials stipulated in Clause 3, Article 20 of this Circular.

4. The drug involves a new combination of herbal materials previously used as drugs in Vietnam and does not include indications for diseases listed in the Disease List issued by the Minister of Health pursuant to Point b, Clause 1, Article 89 of the Medicine Law.

Article 20. Criteria for determining cases exempted from clinical trials in Vietnam before granting circulation permits

1. Generic drugs with the same active ingredient, dosage, concentration, route of administration, method of administration, dose, indication, patient population, and formulation as another drug that has already been granted a registration certificate for circulation.

2. New drugs (excluding vaccines) that have been granted circulation permits in at least one country worldwide and have complete clinical data on safety and efficacy as stipulated in Articles 13 and 18 of this Circular.

3. Traditional medicine drugs that have been granted a registration certificate for circulation prior to the effective date of the 2016 Drug Law and do not have indications for diseases listed in the Disease List issued by the Minister of Health.

4. Vaccines that comply with point d, Clause 4, Article 22 of this Circular, produced entirely through all stages in a country where the regulatory authority is specified in Clause 9, Article 2 of this Circular, and have complete clinical data on safety and efficacy as stipulated in Article 13 of this Circular.

Article 21. Criteria for determining cases required to conduct Phase IV clinical trials in Vietnam

Drugs that have been granted a registration certificate but require additional evaluation of safety and efficacy based on the advisory opinion of the Council.

Chapter III

APPLICATION FILE FOR DRUGS AND RAW MATERIALS FOR DRUGS

Section 1. GENERAL PROVISIONS ON THE APPLICATION FILE FOR GRANTING, EXTENDING, MODIFYING, AND SUPPLEMENTING REGISTRATION CERTIFICATES FOR DRUGS AND RAW MATERIALS FOR DRUGS

Article 22. Provisions for documents in the application file for granting, extending, modifying, and supplementing registration certificates for drugs and raw materials for drugs

1. Documents issued by foreign competent authorities must be legalized consularly according to the provisions of the law on legalization of consular documents, except those exempted according to the law.

2. Permits, certificates, confirmation letters, registrations (collectively referred to as legal documents) in the application file must still be valid at the time of receipt as recorded on the Receipt Form for legal documents with a stated validity period. In cases where the Registration Certificate does not state a validity period, the validity period shall be calculated as twenty-four months from the date of issuance.

3. Legal documents:

a) The original must contain full signatures, names of signatories, and stamps of the issuing authority of the issuing country or certified copies must be certified by a competent authority in Vietnam according to the provisions of Vietnamese law on certification of copies from originals. In case it is necessary to present the original for verification;

b) In cases where legal documents are issued as electronic versions (acceptable without full signatures, names of signatories, or stamps of the issuing authority of the issuing country), the applicant must submit one of the following documents:

- Original or certified copy of the legal document certified by a foreign competent authority and legalized consularly according to the regulations;

- Results of self-searching legal documents from the website or English database of the issuing authority or a competent authority of countries stamped with confirmation seals of the applicant accompanied by a document providing information about the search path to the Department of Medicines Administration. The applicant bears full responsibility under the law for the legality and accuracy of these documents, information, and self-search results.

4. Provisions for Registration Certificates:

a) The Registration Certificate must be issued by a competent authority and contain all contents according to the WHO model published on the WHO website (https://www.who.int).

b) The Registration Certificate must contain signatures, names of signatories, issuance date, and stamp of the issuing authority. In cases where the Registration Certificate does not have a stamp of the issuing authority's competent authority, the applicant must provide documentation proving that the Registration Certificate does not require a stamp according to the regulations of the home country.

c) For generic drugs, traditional medicine drugs, probiotic products, and drugs applying for extension, modification, or supplementation of registration certificates:

There must be one Registration Certificate issued by the competent authority of the producing country confirming that the drug has been approved and actually circulated in that country.

In cases where the Registration Certificate confirms that the drug is not approved for circulation in the producing country or is approved but not actually circulated in the producing country, the applicant must provide an additional legal document issued by the management authority specified in Clause 9, Article 2 of this Circular confirming that the drug has been approved and actually circulated in that country with the minimum contents as follows: drug name, active ingredient, concentration or dosage of the active ingredient, formulation, name and address of the production facility.

d) For new chemical drugs, imported vaccines, and imported bioproducts, excluding probiotic products:

There must be one Registration Certificate issued by the competent authority of the producing country confirming that the drug has been approved and actually circulated in that country.

In cases where the competent authority of the producing country issuing the Registration Certificate belongs to the list specified in Clause 9, Article 2 of this Circular, only one Registration Certificate needs to be submitted.

In cases where the competent authority of the producing country issuing the Registration Certificate does not belong to the list specified in Clause 9, Article 2 of this Circular, there must be an additional legal document issued by the management authority specified in Clause 9, Article 2 of this Circular confirming that the drug has been approved and actually circulated in that country with the minimum contents as follows: drug name, active ingredient, concentration or dosage of the active ingredient, formulation, name and address of the production facility or evidence that the drug belongs to the WHO pre-assessment list.

e) For drugs, vaccines, and imported bioproducts that cannot provide a Registration Certificate meeting the requirements of points c and d of this clause, the Minister of Health will consider and decide based on the advisory opinion of the Council when the drug has been approved for circulation by at least one competent authority worldwide and falls into one of the following situations:

There must be one Registration Certificate issued by the competent authority of the producing country confirming that the drug has been approved and actually circulated in that country.

In cases where the competent authority of the producing country issuing the Registration Certificate belongs to the list specified in Clause 9, Article 2 of this Circular, only one Registration Certificate needs to be submitted.

When the competent authority of the producing country issuing the Registration Certificate does not belong to the list specified in Clause 9, Article 2 of this Circular, there must be an additional legal document issued by the management authority specified in Clause 9, Article 2 of this Circular confirming that the drug has been approved and actually circulated in that country with the minimum contents as follows: drug name, active ingredient, concentration or dosage of the active ingredient, formulation, name and address of the production facility.

e) For drugs, vaccines, and imported bioproducts that cannot provide a Registration Certificate meeting the requirements of points c and d of this clause, the Minister of Health will consider and decide based on the advisory opinion of the Council when the drug has been approved for circulation by at least one competent authority worldwide and falls into one of the following situations:

- Medicines, vaccines, biological products to meet the needs for national defense, security; prevention, control of epidemics, diseases, mitigation of consequences of natural disasters, catastrophes, medicines serving state health programs;

- Vaccines used in the national expanded immunization program that are not available on the market with alternative vaccines having equivalent quantity, quality, safety, efficacy, or cost of use;

- Other special cases with mutual agreements, recognitions between competent authorities regarding conditions for production and circulation of medicines, vaccines, biological products.

g) Information displayed on the Certificate of Pharmaceutical Product (CPP) must be consistent with relevant information in the drug registration dossier. In case the information on the CPP is inconsistent with administrative documents in the drug registration dossier, the registering entity shall provide an explanatory letter accompanied by supporting evidence.

5. The application form and other documents, materials in the administrative part of the dossier must be signed and stamped, without using electronic signatures. The registering and manufacturing entities may use digital signatures to sign related documents of the registering and manufacturing entities. The registration and use of digital signatures shall be carried out in accordance with the provisions of Government Decree No. 130/2018/NĐ-CP dated September 27, 2018, detailing the implementation of the Law on Electronic Transactions concerning digital signatures and digital signature certification services. These documents must be signed by one of the following positions:

a) Chairman of the Board of Members, Board of Directors; General Director; Executive Director; Director of the registering and manufacturing entity;

b) A person designated according to the company's charter, work assignment documents, or other documents proving the signing authority of the signer;

c) A person directly authorized by those specified in point a or point b of this clause to sign.

6. Provisions for power of attorney letters:

a) Power of attorney letters standing in the name of the registering entity must include the following contents:

- Name and address of the owner of the marketing authorization or the manufacturing entity authorized;

- Name and address of the registered entity authorized;

- Drug name; active ingredient concentration; dosage form;

- Content of the authorization.

In the case of multiple drugs, the power of attorney letter must include a list of drugs with all the above contents.

Power of attorney letters standing in the name of the registering entity for foreign drugs must be legalized consularly as prescribed. The power of attorney letter must be the original or certified copy.

b) Power of attorney letters for signing on the registration dossier must include the following contents:

- Name and address of the registering entity;

- Name and position of the authorizing person and the authorized person;

- Drug name; active ingredient concentration, content; dosage form;

- Content of the authorization;

- Validity of the power of attorney letter.

In the case of multiple drugs, the power of attorney letter must include a list of drugs with all the above contents.

In the case where the authorized person signing on the dossier is not the head of the representative office, the power of attorney must have the stamp and signature confirmation of the head of the representative office in Vietnam.

The power of attorney letter must be the original or certified copy with the stamp confirmation of the representative office (in the case of a foreign registering entity) or the stamp confirmation of the domestic registering entity.

c) Number of power of attorney letters in the dossier:

- In the case where the registering entity is different from the manufacturing entity, each dossier must be accompanied by one power of attorney letter standing in the name of the registering entity;

- In the case where the position of the person signing on the dossier does not belong to any of the positions specified in points a and b of Clause 5 of this Article, each dossier must be accompanied by one power of attorney letter for signing on the registration dossier.

7. Certificate of eligibility for pharmaceutical business in one of the forms of business: manufacturing, wholesale, export, import of drugs, raw materials for drugs (for Vietnamese registering entities).

8. Permit to establish a Representative Office in Vietnam.

In the case where the name and address of the registering entity on the permit to establish a Representative Office in Vietnam differ from the name and address on the legal documents of the registering entity issued by the competent authority of a foreign country, proof documents must be provided.

9. Legal documents issued by the competent authority of a foreign country allowing at least one of the following forms of business: manufacturing, wholesale, export, import of drugs, raw materials for drugs (for foreign registering entities).

In the case where the registering entity for drugs is simultaneously the manufacturing entity for drugs recorded on the CPP, there is no need to submit legal documents as stipulated in this clause.

In the case where countries do not issue permits for manufacturing, wholesaling, exporting, importing drugs, raw materials for drugs, they must have a business establishment or registration certificate with a scope of business being at least one of the following forms: manufacturing, wholesaling, exporting, importing drugs, raw materials for drugs, accompanied by a certificate from the competent authority certifying that the entity meets the conditions and is operating in the pharmaceutical sector or one of the Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Supply Practice (GSP), Good Storage Practice (GSP) certificates.

For registering entities of raw materials for drugs, in the case where the host country does not issue pharmaceutical business permits for entities dealing in raw materials for drugs, accept permits according to the regulations of the host country which specify that the scope of business of the entity includes at least one of the following forms: manufacturing, wholesaling, exporting, importing raw materials for drugs.

10. In the case where the registering entity is already listed in the register of drug and raw material registering entities published on the website of the Department of Medicine Management, there is no need to submit documents as stipulated in Clauses 7, 8, and 9 of this Article.

11. Documents proving that the manufacturing facilities for active ingredients, excipients, gelatin capsules, semi-finished herbal medicines, and herbal medicines (for the manufacture of herbal medicines) comply with Good Manufacturing Practice (GMP) can be one of the following types of documents:

a) GMP certificate;

b) Production license confirming that the manufacturing facility complies with GMP;

c) CPP for active ingredients containing GMP compliance information;

d) Certificate of Suitability of the European Pharmacopoeia (CEP);

đ) For excipients in the finished drug registration dossier, raw materials for drugs are semi-finished products:

In case the required documents specified in any of points a, b, or d of this clause cannot be provided, the finished drug production facility or semi-finished drug production facility shall self-assess the compliance with good manufacturing practices (GMP) for the excipient production facility according to point đ of Clause 1, Article 3, point b of Clause 3, Article 3, and point đ of Clause 5, Article 20 of Circular No. 35/2018/TT-BYT dated November 22, 2018, issued by the Minister of Health on Good Manufacturing Practices for Drugs and Active Pharmaceutical Ingredients (amended and supplemented by points a, b, and đ of Clause 6, Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020, issued by the Ministry of Health to amend, supplement, and abolish certain legal normative documents promulgated by the Minister of Health and jointly promulgated), and declare in the drug registration dossier regarding the principles and standards of GMP that the excipient production facility complies with, and commit to bear legal responsibility for such declaration according to Model 10/TT attached hereto.

e) For medicinal materials in the drug registration dossier:

In case the required documents specified in points a and b of this clause cannot be provided, the supplier shall provide a certificate confirming compliance with good agricultural and collection practices (GACP) for medicinal materials.

g) Other legal documents issued by authorized agencies must include at least the following contents: name and address of the manufacturer, confirmation that the production facility meets GMP requirements, and the name of the active pharmaceutical ingredient, excipient, capsule shell, semi-finished medicinal material, or medicinal material.

12. The label sample of drugs and raw materials for drugs, and the actual user guide in the country of manufacture or the country issuing the Certificate of Pharmaceutical Product (CPP) must bear the confirmation stamp of the representative office or the registration entity or the production facility (color printouts according to the current label in the home country are acceptable). In cases where the actual user guide in the home country is not in English, a certified translation into English or Vietnamese with the confirmation stamp of the representative office or the registration entity or the production facility must be submitted.

13. The label sample of drugs and raw materials for drugs, and the proposed user guide for circulation in Vietnam must comply with the labeling regulations for drugs and raw materials for drugs stipulated by the Minister of Health and the following specific requirements:

a) The proposed label and user guide for circulation must bear the confirmation stamp of the representative office or the registration entity or the production facility;

b) The outer packaging label of drugs and raw materials for drugs must be printed with a barcode, QR code, or DataMatrix Code (DMC) according to the schedule specified in point l of Clause 1, Article 48 of this Circular.

14. If the drug production facility or raw material production facility is listed in the published directory of production facilities evaluated as meeting GMP requirements on the website of the Drug Administration Department, there is no need to submit the evaluation dossier for compliance with good manufacturing practices in the drug registration dossier.

15. Quality standards, testing methods, test reports, and stability research files (applicable to both the active pharmaceutical ingredient and finished drug parts) must be original copies bearing the confirmation stamp of the production facility; if multiple production facilities participate in the finished product manufacturing process, the stamp of the facility responsible for quality control or release of the batch is acceptable; if a copy is submitted, it must bear the confirmation stamp of the registration entity (the stamp of the representative office is acceptable for foreign drugs).

If the active pharmaceutical ingredient dossier does not have the confirmation stamp of the active pharmaceutical ingredient production facility, the finished drug production facility must affix its own confirmation stamp and bear legal responsibility for the accuracy, legality, and truthfulness of this document.

The test report must include the following information: administrative information (name and address of the production facility, test report number, name and signature of the person assigned responsibility, date of issuance of the test report) and information about the drug or raw material sample (product name, batch number, expiration date, applicable quality standard, quality specifications, quality requirements, test results, conclusion on the quality of the batch).

16. Requirements for test reports, results of quality standard assessments, and experimental testing methods in Vietnam:

Test reports, results of quality standard assessments, and experimental testing methods for production facilities that have not yet met GMP requirements according to the Ministry of Health's schedule or those notified by the Drug Administration Department according to Appendix III attached to this Circular must be original or certified copies bearing the confirmation stamp of a state drug testing laboratory meeting Good Laboratory Practice (GLP) requirements or a drug testing service business that has been granted a business license appropriate to its scope of operation.

17. The certificate of permission for the production or circulation of raw materials for drugs in the country of manufacture must include the following mandatory information: name of the raw material; name and address of the production facility; country of manufacture; signature, stamp, and full name of the person signing the confirmation letter.

Article 23. General provisions on administrative documents in the application dossier for issuing, extending, changing, and supplementing the drug registration certificate

1. Administrative documents of the application dossier for issuing a new chemical drug, vaccine, or biological product registration certificate include:

a) The registration form according to Form 5/TT issued together with this Circular;

b) Power of attorney for the registering entity (if applicable);

c) Power of attorney for signing the registration dossier (if applicable);

d) Sample labels of drugs and drug ingredients and the proposed drug usage instructions;

đ) Certificate of eligibility for pharmaceutical business operations for domestic registering entities;

e) Legal documents and establishment permits for representative offices in Vietnam for foreign registering entities;

g) Product characteristics summary for new chemical drugs, vaccines, and biological products according to Form 6/TT issued together with this Circular;

h) Legal documents of drug substance, excipient, capsule shell, semi-finished herbal medicine, and herbal medicine production facilities;

i) Certificates from testing laboratories as stipulated in Clause 16, Article 22 of this Circular;

k) Risk management plan (for vaccines) according to Form 7/TT issued together with this Circular;

l) Labels and actual drug usage instructions circulating in the country of manufacture or the country of Certificate of Pharmaceutical Product (CPP) issuance for foreign drug registration dossiers;

m) Certificate of Pharmaceutical Product for foreign drug registration dossiers;

n) Documentation evaluating compliance with Good Manufacturing Practices (GMP) as stipulated in Article 95 of Decree No. 54/2017/NĐ-CP for foreign drug and drug ingredient manufacturing facilities applying for circulation in Vietnam, except where the facility has been publicly announced as compliant with GMP on the website of the Drug Administration or has submitted an application for GMP compliance evaluation to the Drug Administration;

2. Administrative documents of the application dossier for issuing a generic drug, herbal drug, or drug ingredient registration certificate, as provided in points a, b, c, d, đ, e, h, i, l, m, n of Clause 1 of this Article, and a certificate of permission to produce or circulate drug ingredients in the country of manufacture for foreign drug ingredient production registration dossiers;

3. Administrative documents of the application dossier for extending the drug registration certificate for chemical drugs, vaccines, biological products, herbal drugs, and drug ingredients include:

a) Application for extension of the drug registration certificate according to Form 5B/TT issued together with this Circular;

b) Valid Certificate of Pharmaceutical Product for imported drugs;

c) Safety and efficacy reports during circulation according to Form 2D/TT issued together with this Circular.

4. Administrative documents of the application dossier for changing or supplementing the drug registration certificate for chemical drugs, vaccines, biological products, herbal drugs, and drug ingredients as provided in points a, c of Clause 1 of this Article.

5. Administrative documents of the application dossier for issuing a drug registration certificate through the expedited review process as provided in points a, b, c, d, đ, e, h, i, l, m of Clause 1 of this Article.

Section 2. APPLICATION DOSSIER FOR ISSUING, EXTENDING, CHANGING, AND SUPPLEMENTING THE REGISTRATION CERTIFICATE FOR CHEMICAL DRUGS, VACCINES, AND BIOLOGICAL PRODUCTS

Article 24. Quality Documents in the Application for Registration, Change, or Supplement to the Drug Circulation Permit for Chemical Drugs, Vaccines, and Medical Biological Products

Quality documents shall be implemented according to the guidelines in Part II - ACTD or Section 3-ICH-CTD and the following regulations:

1. For vaccines, serum containing antibodies, and human blood derivatives:

a) A batch release certificate issued by the competent authority of the exporting country or one of the regulatory bodies specified in Clause 9, Article 2 of this Circular;

b) Test reports, quality standards, and testing methods confirmed by the National Institute of Vaccines and Medical Biological Products Control.

2. For rare drugs, drugs for defense and security needs; prevention and control of epidemics, diseases, disaster relief, and special treatment needs:

a) Rare drugs for treating rare diseases: stability research data available according to ASEAN or ICH guidelines;

b) Drugs for defense and security needs; prevention and control of epidemics, diseases, disaster relief:

Acceptance of existing stability research data at the time of application submission for consideration of the drug's shelf life based on the Council's opinion in cases where the drug's stability research period does not meet the minimum research time requirements according to ASEAN guidelines.

After obtaining the circulation permit, the entity must continue to submit finished product stability research reports until the actual minimum stability research period meets ASEAN guidelines for the Department of Drug Management through changes or supplements as stipulated in Appendix II of this Circular to review and update the drug's shelf life as required.

In cases where the drug fails to meet the stability research results outlined in the registration dossier, the entity must immediately report to the Department of Drug Management for the Council's review regarding the drug's shelf life.

Based on the Council's advisory opinion, the Department of Drug Management will consider and decide on the drug's shelf life, including batches already produced, based on actual stability research data.

c) Special treatment need drugs: stability research data available according to ASEAN or ICH guidelines decided by the Minister of Health based on the Council's opinion when the registering entity proves that the drug cannot be stored under ASEAN's climate zone IVb conditions.

3. In cases where the manufacturing entity uses raw materials that have already been granted a circulation permit in Vietnam:

a) There is no requirement to submit quality documents related to raw materials and those specified in Point h, Clause 1, Article 23 of this Circular in the finished drug registration dossier;

b) The registering entity must submit:

- One test report on raw material conducted by the finished drug manufacturer with all quality criteria at least equivalent or stricter than the raw material manufacturer's standard. If the finished drug manufacturer lacks the capability to test all quality criteria, it must provide analysis reports for the missing criteria performed by a state inspection agency or a drug raw material testing service provider that has obtained a business license;

- One test report on raw material conducted by the raw material manufacturer.

4. For drugs proposed to follow the abbreviated review process:

a) The active substance dossier section:

- Name of the active substance (recorded according to the international name);

- Name and address of the active substance manufacturer and intermediate product containing the active substance;

- Quality standards and testing methods for the active substance and intermediate products. If the drug is registered according to the Vietnamese Pharmacopoeia or reference pharmacopoeia as prescribed by the Ministry of Health, only the pharmacopoeia name, version, or current pharmacopoeia should be recorded;

- One test report on the active substance and intermediate product from the active substance manufacturer and one test report on the active substance and intermediate product from the finished drug manufacturer;

- For active substances in the form of intermediates, there must also be a formulation and production process for the intermediate product containing the active substance from the intermediate product manufacturer.

b) Finished product dossier section:

- Description and composition according to the guidelines in Part P.1 - ACTD;

- Quality standards and testing methods for the finished drug. If registered according to the Vietnamese Pharmacopoeia or reference pharmacopoeia as prescribed by the Ministry of Health, only the pharmacopoeia name, version, or current pharmacopoeia should be recorded;

- Finished product manufacturing, including batch formula, production process and process control, critical steps control, and intermediate products.

- Finished product test report;

- Primary packaging: Description of form, material, and primary packaging quality standards;

- Finished product stability research report.

c) Remaining quality dossier documents shall be implemented according to the guidelines in Part II - ACTD or Section 3-ICH-CTD kept at the registering entity and the manufacturing entity.

5. The documents specified in this Article must comply with the following regulations:

a) Apply the provisions in Appendix I attached to this Circular, including:

- ASEAN Common Technical Document (ACTD);

- Stability Research Guidelines;

- Production Process Review Guidelines;

- Analytical Method Review Guidelines;

- Bioavailability and Bioequivalence Research Guidelines;

b) For drug dossiers prepared according to ICH-CTD templates and corresponding technical guidance from ICH, there is no requirement to convert the dossier according to the provisions in point a of this clause;

c) In cases where raw materials have a Certificate of Suitability (CEP) for European Pharmacopoeia (EP): The active substance dossier in points a and b of this clause can be replaced by submitting the following documents:

- Certificate of Suitability (CEP) for the active substance along with all appendices issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM);

- Batch analytical data.

- If the retesting period for the drug substance quality is not stated in the Common Technical Document (CTD), submit the research data on the stability of the drug substance.

Article 25. Preclinical Data in the Application for Issuance, Amendment, or Supplement to the Drug Registration Certificate for Chemical Drugs, Vaccines, and Biologics

Preclinical data shall be conducted in accordance with the guidelines set forth in Part III-CTD or Module 4-ICH-CTD.

For probiotic biologics with origins, bacterial strains, concentrations, contents, indications, and dosages similar to those of biologics approved by one of the regulatory authorities specified in Clause 9, Article 2 of this Circular, there is no need to submit preclinical data.

Article 26. Clinical Data in the Application for Issuance, Amendment, or Supplement to the Drug Registration Certificate for Chemical Drugs, Vaccines, and Biologics

Clinical data shall be conducted in accordance with the guidelines set forth in Part IV-CTD or Module 5-ICH-CTD.

For probiotic biologics with origins, bacterial strains, concentrations, contents, indications, and dosages similar to those of biologics approved by one of the regulatory authorities specified in Clause 9, Article 2 of this Circular, clinical data is not required.

Article 27. Application for Issuance, Extension, Amendment, or Supplement to the Drug Registration Certificate for Chemical Drugs, Vaccines, and Biologics

1. The application for issuance of a new chemical drug registration certificate, vaccine, or biologic shall include:

a) Administrative documents as prescribed in Clause 1, Article 23 of this Circular.

b) Quality data as prescribed in Article 24 of this Circular;

c) Preclinical data as prescribed in Article 25 of this Circular;

d) Clinical data as prescribed in Article 26 of this Circular;

đ) In cases where the applicant requests classification of the original brand name or reference biologic when submitting the application for issuance of a drug registration certificate, the provisions of points a, b, c, and d of Clause 1 of this Article and paragraph 2 of point a of Clause 1 of Article 9 of this Circular shall apply.

2. The application for issuance of a generic drug registration certificate shall include:

a) Administrative documents as prescribed in Clause 2, Article 23 of this Circular;

b) Quality data as prescribed in Article 24 of this Circular.

3. [6] The application for extension of the drug registration certificate for chemical drugs, vaccines, and biologics:

Documents as prescribed in Clause 3, Article 23 of this Circular. In cases where administrative information about the drug being extended changes, including the name and address of the registration entity, or the name and address of the manufacturing entity, the registration entity shall submit an application for amendment or supplement according to the provisions of Clause 4 of this Article. In cases where the drug name is changed, the registration entity may implement such change in the application for extension and clearly state it in the Request for Extension of the Drug Registration Certificate.

4. The application for amendment or supplement to the drug registration certificate shall include:

a) Administrative documents as prescribed in Clause 4, Article 23 of this Circular;

b) Relevant documents corresponding to major and minor changes as prescribed in Appendix II issued together with this Circular. For vaccines produced by the same manufacturing entity or the owner of the drug marketing authorization accepting changes in the production site within the same country or outside the country where the drug registration certificate has been issued.

5. The application for issuance of a drug registration certificate through a streamlined review process shall include:

a) Administrative documents as prescribed in Clause 5, Article 23 of this Circular;

b) Quality data as prescribed in points a and b of Clause 4, Article 24 of this Circular.

Section 3. APPLICATION DOCUMENTS FOR THE ISSUE, EXTENSION, CHANGE, AND SUPPLEMENTATION OF THE DRUG REGISTRATION LICENSE

Article 28. Quality Documents in Application Documents for the Issue, Change, and Supplement of the Drug Registration License

1. Raw Materials

a) Production Process (applicable only to raw material of medicinal herbs): Detailed and comprehensive description of the preliminary processing and manufacturing process of medicinal herb raw materials. If the raw material is semi-finished medicinal herb products or medicinal herb extracts, it must detail the production process of semi-finished medicinal herb products or medicinal herb extracts from medicinal herb raw materials (except where semi-finished medicinal herb products or medicinal herb extracts have already been issued a registration license).

b) Quality Standards and Testing Methods

- For medicinal herbs not in the form of semi-finished medicinal herb products: carried out according to the provisions of Circular No. 38/2021/TT-BYT;

- For semi-finished medicinal herb products, similar quality standards and testing methods applicable to medicinal herbs not in the form of semi-finished medicinal herb products as stipulated in Circular No. 38/2021/TT-BYT shall be applied.

c) Raw Material Test Report

- One test report of medicinal herbs from the finished drug manufacturer. In cases where the finished drug manufacturer does not have the capability to test all quality indicators, the manufacturer must provide analysis reports for the missing quality indicators conducted by State Testing Agencies or drug testing service businesses that have obtained a business license for drug testing services;

- One test report of semi-finished medicinal herb products or medicinal herb extracts from the semi-finished medicinal herb product or medicinal herb extract manufacturer and one test report of semi-finished medicinal herb products or medicinal herb extracts from the finished drug manufacturer.

2. Finished Products

a) Production Process

- Formula for the smallest packaging unit: name, content, concentration, weight, and applicable standard of each component in the formula for one smallest packaging unit. In cases where production is from semi-finished medicinal herb products or medicinal herb extracts, the corresponding weight of medicinal herbs for semi-finished medicinal herb products or medicinal herb extracts or the ratio of medicinal herb extracts or semi-finished medicinal herb products to initial medicinal herbs or accompanied by the percentage content of active ingredients or quantified compound groups according to each medicinal herb must be clearly stated;

- Formula for a batch of finished drugs: clearly state the name, weight, volume of each component in the batch formula;

- Production process flowchart: fully display all stages in the drug production process including the path of raw materials and consistent with the described production process;

- Description of the drug production process: fully and detailedly describe each step in the production process stages including all technical parameters of each stage;

- Equipment list: equipment name, specifications, purpose of use;

- Control during production: fully and detailedly describe the inspection and control criteria for each stage including the name of the criterion, acceptance standard, control method, frequency of control, number of samples taken for control;

b) Quality Standards and Testing Methods

- Formula for the smallest packaging unit: name, content, concentration, weight, and applicable standard of each component in the formula for one smallest packaging unit. In cases where production is from semi-finished medicinal herb products or medicinal herb extracts, the corresponding weight of medicinal herbs for semi-finished medicinal herb products or medicinal herb extracts or the ratio of medicinal herb extracts or semi-finished medicinal herb products to initial medicinal herbs or accompanied by the percentage content of active ingredients or quantified compound groups according to each medicinal herb must be clearly stated;

- Finished product standards: carried out according to the provisions of Circular No. 11/2018/TT-BYT;

c) Finished Product Test Report;

d) Packaging Material Standards: fully and detailedly describe the packaging material, quality criteria, quality level, and testing methods;

đ) Stability Research Report according to the stability research guidelines specified in Appendix I attached to this Circular.

Article 29. Safety and efficacy documentation in the application dossier for registration, extension, change, or supplement to the drug registration certificate for herbal medicines

1. Safety and efficacy documentation for herbal medicines shall be carried out according to the provisions of Appendix V issued together with this Circular or the ASEAN (ACTD), ICH-CTD regulations.

2. Documentation as specified in point b, Clause 1, Article 18 of this Circular (if applicable).

Article 30. Application dossier for registration, extension, change, or supplement to the drug registration certificate for herbal medicines

1. The application dossier for registration of the drug registration certificate for herbal medicines includes:

a) Administrative documents as prescribed in Clause 2, Article 23 of this Circular;

b) Quality documentation as stipulated in Article 28 of this Circular;

c) Safety and efficacy documentation as stipulated in Article 29 of this Circular;

2.[7] The application dossier for extension of the drug registration certificate for herbal medicines:

Documents as prescribed in Clause 3, Article 23 of this Circular. In case there are changes to administrative information of the drug being applied for extension of the registration certificate including name, address of the registering entity; name, address of the manufacturing entity, the registering entity shall submit an application dossier for change or supplement as prescribed in Clause 3 of this Article. If the drug name is changed, the entity may implement it in the extension application dossier and clearly record it in the Drug Registration Extension Request Form.

3. The application dossier for change or supplement to the drug registration certificate for herbal medicines includes:

a) Administrative documents as prescribed in Clause 4, Article 23 of this Circular;

b) Documentation corresponding to major and minor changes as specified in Section D of Appendix II issued together with this Circular.

Chapter 4. APPLICATION DOSSIER FOR DRUG RAW MATERIALS

Article 31. Quality documentation in the application dossier for registration, change, or supplement to the drug registration certificate for raw materials

1. For drug active substances: Follow the ACTD dossier for active substances. In cases where the quality of the active substance is registered according to the manufacturer's standard, the overall active substance dossier (Drug Master File) must be submitted along with the general dossier.

2. For semi-finished products containing active substances: Follow the ACTD dossier as for finished drug registration, wherein the finished product dossier is replaced by the semi-finished product registration dossier; dosage formulas and smallest unit packaging formulas are replaced by production batch formulas.

3. For semi-finished herbal medicine, excipient, capsule shell:

a) Formulation for semi-finished herbal medicine, pre-mixed excipient, capsule shell: components, weight, volume, quality standards of each component in the formula. In cases where animal-derived raw materials are used, information on random substances (virus safety data) must be provided.

b) Production process

- Production process flowchart: fully displaying all stages in the production process including the path of raw materials and consistent with the production process description;

- Production process description: fully and detailedly describing each step in the production process including all technical parameters of each stage;

- Equipment list: equipment name, specifications, purpose of use;

- In-process control: Fully and detailedly describing inspection and control criteria for each stage including test item name, acceptance criteria, control method, frequency of control, number of samples taken for control.

c) Quality standards and testing methods

- For semi-finished herbal medicine, apply similar provisions regarding quality standards and testing methods for non-semi-finished herbal medicine as stipulated in Circular No. 38/2021/TT-BYT;

- For excipients, capsule shells: follow the provisions stipulated in Circular No. 11/2018/TT-BYT.

d) Test report;

đ) Packaging material standards: Fully and detailedly describe packaging material, quality criteria, quality level, and testing methods;

e) Stability research report, including stability research outline; stability research data; results and discussion.

Article 32. Documents for Application to Issue, Extend, Amend, and Supplement the Drug Raw Material Circulation Registration Certificate

1. Documents for Application to Issue the Drug Raw Material Circulation Registration Certificate include:

a) Administrative documents as prescribed in Clause 2, Article 23 of this Circular;

b) Quality documents as prescribed in Article 31 of this Circular.

2. Documents for Application to Extend the Drug Raw Material Circulation Registration Certificate:

Documents as prescribed in Clause 3, Article 23 of this Circular. In cases where there are changes in administrative information of the raw material being applied for extension of the registration certificate, including the name and address of the registering entity; the name and address of the manufacturing entity, the registering entity shall submit documents for application to amend and supplement according to the provisions of Clause 3 of this Article. In case of change in the name of the raw material, the entity may implement it in the application for extension and clearly record it in the Application Form for Extension of the Drug and Drug Raw Material Circulation Registration Certificate.

3. Documents for Application to Amend and Supplement the Drug Raw Material Circulation Registration Certificate include:

a) Administrative documents as prescribed in Clause 4, Article 23 of this Circular;

b) Documents corresponding to major and minor changes as prescribed in Part B of Appendix II issued together with this Circular.

Chapter IV

PROCEDURES FOR ISSUING, EXTENDING, AMENDING, AND SUPPLEMENTING THE DRUG AND DRUG RAW MATERIAL CIRCULATION REGISTRATION CERTIFICATE; SEQUENCE OF REVIEWING IMPORT LICENSE APPLICATIONS FOR DRUGS WITHOUT A CIRCULATION REGISTRATION CERTIFICATE

Article 33. Cases to be Implemented According to the Fast Review Process and Simplified Review Process

1. Cases to be Implemented According to the Fast Review Process

The drug registration dossier will be reviewed according to the fast review process when meeting one of the following conditions:

a) Drugs listed in the Rare Drugs Catalogue issued by the Minister of Health;

b) Drugs that meet urgent needs for national defense, security, epidemic prevention, disaster relief;

c) Domestic drugs produced on new production lines meeting GMP standards or upgraded lines meeting GMP-EU, GMP-PIC/S and equivalent standards within a period not exceeding 18 months from the date of issuance of the GMP certificate;

d) Vaccines pre-evaluated and found satisfactory by WHO, vaccines used in the national expanded immunization program;

đ) Specialized therapeutic drugs, drugs with special dosage forms, only having no more than 02 (two) similar drugs (same active ingredient, same dosage form, same strength) with valid circulation registration certificates in Vietnam at the time of submission of the dossier, including:

- Anti-cancer drugs;

- New generation antiviral drugs;

- New generation antibiotics;

- Drugs used in dengue fever, tuberculosis, malaria treatment;

- Immunosuppressants used in organ transplantation.

e) Domestic drugs, including:

- Drugs manufactured through contract manufacturing or technology transfer in Vietnam for anti-cancer drugs, vaccines, biological products, new generation antiviral drugs, new generation antibiotics, immunosuppressants used in organ transplantation;

- Herbal drugs with national, ministry, or provincial-level scientific and technological projects that have been successfully completed and met requirements, drugs entirely produced from domestic herbal materials meeting GAP standards;

- Newly produced domestic drugs that have completed clinical trials in Vietnam;

g) New drugs (anti-cancer drugs, new generation antiviral drugs, new generation antibiotics), reference biological products;

h) Original brand drugs manufactured through contract manufacturing or technology transfer in Vietnam;

i) Drugs changing manufacturing sites leading to the need for a new circulation registration certificate according to Point b, Clause 2, Article 55 of the Medicine Law.

2. Cases to be Reviewed According to the Simplified Review Process

The drug registration dossier will be reviewed according to the simplified review process when meeting all of the following conditions simultaneously:

a) Drugs produced at facilities regularly assessed by the Drug Administration of Vietnam for compliance with Good Manufacturing Practices;

b) Drugs listed in the Over-the-Counter Drugs Catalogue;

c) Drugs not in modified release dosage forms;

d) Drugs not intended for direct use in the eyes.

Article 34. Competence to issue, extend, change, and supplement drug registration certificates and raw material for drug production[9]

1. The Drug Administration of Vietnam and units determined by the Minister of Health (hereinafter referred to as the assessment unit) shall organize the assessment of applications for issuing, extending, changing, and supplementing drug registration certificates and raw material for drug production, except in cases provided for in point d, Clause 2 of this Article.

2. Drug Administration:

a) Issue, approve changes and supplements to drug registration certificates and raw material for drug production, announce original brand names, reference medicinal products, and drugs with bioequivalence study reports based on the assessment of application files and advice from the Council for each specific case or the general policy of the Council applicable to each type of change or supplement, except in cases provided for in point d of this clause;

b) Extend drug registration certificates and raw material for drug production based on the assessment of application files and advice from the Council for the following cases:

- Drugs specified in Clause 2, Article 8 of this Circular;

- Drugs or raw material for drug production subject to compulsory or voluntary recall due to non-compliance with quality standards during circulation since the last issuance or extension of the drug registration certificate;

- Drugs experiencing serious adverse events during circulation reported in Form 2D/TT issued together with this Circular.

c) Extend drug registration certificates and raw material for drug production without requiring the assessment of application files and advice from the Council for cases not covered by point b of this clause.

d) Announce on the Drug Administration of Vietnam's electronic information website the changes and supplements to drug registration certificates and raw material for drug production that only require notification for minor changes without requiring file assessment and Council advice.

Article 35. General provisions on procedures for issuing, extending, changing, and supplementing drug registration certificates and raw material for drug production

1. Application files may be submitted online, directly, or sent via postal service to the Drug Administration of Vietnam.

2. After receiving complete application files, the Drug Administration of Vietnam will issue a receipt for the application files according to Form 9/TT issued together with this Circular to the registering entity.

The Drug Administration of Vietnam accepts application files without the mandatory submission of CPP for cases stipulated in point e, Clause 4, Article 22 of this Circular and documents stipulated in point b, Clause 1, Article 24 of this Circular at the time of submitting the application files.

3. For application files for imported drugs without a registration certificate, the acceptance of application files shall be carried out in accordance with the provisions of point b, Clause 1, Article 77 of Decree No. 54/2017/NĐ-CP.

4. Assessment of application files for issuing, extending, changing, and supplementing drug registration certificates and raw material for drug production and application files for imported drugs without a registration certificate:

a) The Drug Administration of Vietnam transfers application files to experts or units assigned tasks by the Ministry of Health for assessment based on a list of experts established and approved by the Drug Administration of Vietnam or the assessment units;

b) Based on the consolidated opinions of the experts or assessment units and related information, the Drug Administration of Vietnam is responsible for proposing the issuance, extension, change, and supplement or refusal to issue, extend, change, and supplement drug registration certificates and raw material for drug production; issuance or refusal to issue import permits for drugs without a registration certificate. The proposal opinion of the Drug Administration of Vietnam is reflected in the assessment minutes;

c) The Drug Administration of Vietnam submits the Council for review and advice on the proposals of the Drug Administration of Vietnam stipulated in point b of this clause for the following cases:

- Issuance, non-issuance; extension, non-extension for cases specified in point b, Clause 2, Article 34 of this Circular, suspected counterfeit legal documents; approval, non-approval of changes and supplements to drug registration certificates and raw material for drug production;

- Announcement, non-announcement of original brand names, reference medicinal products, except when the drug registration entity does not need to submit an application for classification of original brand names, reference medicinal products as stipulated in Article 9 of this Circular;

- Issuance, non-issuance of import permits for drugs without a registration certificate;

- Other cases proposed by the Drug Administration of Vietnam to meet urgent needs in disease prevention and treatment.

5. For application files requesting issuance, extension, change, and supplement of drug registration certificates and raw material for drug production, the entity is only allowed to modify and supplement up to three times. If the number of modifications and supplements exceeds the above limit and the modified and supplemented files still do not meet requirements, the Drug Administration of Vietnam will issue a notice disagreeing with the issuance, extension of the drug registration certificate, and disapproving the modification and supplement application. Submitted files will lose their validity.

Article 36. Procedures for Issuing Drug Registration Certificates and Review Process for Importing Drugs Without Registration Certificates

1. Within a maximum period of twelve months from the date of receipt of complete application files for issuing drug registration certificates (except for cases stipulated in Article 39 of this Circular), the Department of Medicines Management shall issue drug registration certificates. In case of non-issuance or delay in issuance, the Department of Medicines Management shall provide a written response stating the reasons. The timeframes for each step are specified as follows:

a) Within two months from the date of receiving the file, the Department of Medicines Management will review, classify, and forward the file to experts or units for assessment. Within six months from the date of receiving the file from the Department of Medicines Management, the experts or units for assessment must complete the assessment report and submit it to the Department of Medicines Management for consolidation and proposal of opinions on the assessment report in accordance with Clause 4, Article 35 of this Circular;

b) Within two months from the date of receiving the assessment report, the Department of Medicines Management shall provide a written response to the file that has not met the requirements and clearly state the reasons. For files proposed for issuance, non-issuance, or requiring consultation from the Council by the Department of Medicines Management, the Department of Medicines Management shall transfer them to the Council Office to organize a meeting of the Council;

c) Within one month from the date of receiving materials from the Department of Medicines Management, the Council Office shall organize a Council meeting and send the Council meeting minutes back to the Department of Medicines Management;

d) Within one month from the date of receiving the Council meeting minutes, the Department of Medicines Management shall issue a decision to issue a drug registration certificate for files that meet the requirements; the Department of Medicines Management shall provide a written response according to the Council's conclusion for files that have not met the requirements, not met, and clearly state the reasons.

2. Within thirty-six months for cases requiring additional preclinical and clinical data, bioequivalence data, stability study data, or within twelve months for other cases requiring additional data, from the date the Department of Medicines Management issues a notification, the applicant must submit supplementary materials as required. After this period, if the applicant does not submit supplementary materials, the submitted file will lose its validity.

The applicant is permitted to update in writing to the Department of Medicines Management about the submitted registration file and during the review period for cases updating information related to the safety and efficacy of drugs or legal documents of the applicant, drug manufacturing facility, or raw material production facility compared to the previously submitted file.

The time from the date of the Department of Medicines Management's notification to the date the applicant submits supplementary materials shall not be included in the timeframe specified in Clause 5, Article 56 of the Medicine Law.

3. Within six months from the date of receipt of complete supplementary materials, the Department of Medicines Management shall issue a decision to issue a drug registration certificate for files that meet the requirements or provide a written response for files that have not met the requirements according to the Council's conclusion or provide a written response for files that have not met the requirements and clearly state the reasons. The timeframes for each step are specified as follows:

a) Within one month from the date of receiving the file, the Department of Medicines Management will review, classify, and forward the file to experts or units for assessment. Within two months from the date of receiving the file from the Department of Medicines Management, the experts or units for assessment must complete the assessment report and submit it to the Department of Medicines Management for consolidation and proposal of opinions on the assessment report in accordance with Clause 4, Article 35 of this Circular;

b) Within one month from the date of receiving the assessment report, the Department of Medicines Management shall provide a written response to the file that has not met the requirements and clearly state the reasons. For files proposed for issuance, non-issuance, or requiring consultation from the Council by the Department of Medicines Management, the Department of Medicines Management shall transfer them to the Council Office to organize a Council meeting;

c) Within one month from the date of receiving materials from the Department of Medicines Management, the Council Office shall organize a Council meeting and send the Council meeting minutes back to the Department of Medicines Management;

d) Within one month from the date of receiving the Council meeting minutes, the Department of Medicines Management shall issue a decision to issue a drug registration certificate for files that meet the requirements; the Department of Medicines Management shall provide a written response according to the Council's conclusion for files that have not met the requirements, not met, and clearly state the reasons.

4. Review process for importing drugs without registration certificates:

a) Within five working days from the date of receipt of complete files, the Department of Medicines Management will transfer the files to experts or units for assessment.

The assessment period shall not exceed thirty days for files that do not require clinical data, proof of similarity with reference products, or sixty days for files that require clinical data or proof of similarity with reference products from the date the Department of Medicines Management transfers the files to the experts or units for assessment;

b) Within twenty days from the date of receiving the assessment report:

- The Department of Medicines Management will consolidate the assessment opinions of the experts or units for assessment and consider relevant information to propose the issuance, non-issuance, or refusal of import permits for drugs without registration certificates.

- For files that need to be referred to the Council in accordance with Point c, Clause 4, Article 35 of this Circular, the Department of Medicines Management shall refer them to the Council at the next meeting;

- For files that have not met the requirements, the Department of Medicines Management shall provide a written response and clearly state the reasons.

c) Within five working days from the date of receiving the Council meeting minutes, the Department of Medicines Management shall issue an Import Permit for files that meet the requirements; or provide a written response according to the Council's conclusion for files that have not met the requirements or do not meet the requirements and clearly state the reasons;

d) After receiving the revised and supplemented files from the importer, the Department of Medicines Management shall implement the provisions at Points a, b, and c of this clause.

For files where the Council requires revisions and supplements but does not require referral to the Council again, the Department of Medicines Management shall notify the applicant to make revisions and supplements; if the revised and supplemented files meet the requirements, the Department of Medicines Management shall issue the permit without referring to the Council again.

Article 37. Procedure for Extending the Drug Registration Certificate

1.[11] Within three months from the date of receiving complete files, the Department of Medicine Management shall extend the drug registration certificate for cases specified in point b, Clause 2, Article 34 of this Circular. In case of non-extension or delay in extension, the Department of Medicine Management shall provide a written response specifying the reasons; the timeframes for each step are as follows:

a) Within eight working days from the date of receiving the file, the Department of Medicine Management shall review, classify, and send the file to the experts or units for assessment. Within one month from the date of receiving the file from the Department of Medicine Management, the experts or units for assessment must complete the assessment report and submit it to the Department of Medicine Management for consolidation and conclusion according to Clause 4, Article 35 of this Circular;

b) Within twelve working days from the date of receiving the assessment report, the Department of Medicine Management shall provide a written response for the files that have not met the requirements and specify the reasons. For files proposed for extension, non-extension, or requiring the opinion of the Council, the Department of Medicine Management shall transfer them to the Council Office to organize a meeting of the Council;

c) Within six working days from the date of receiving materials from the Department of Medicine Management, the Council Office shall organize a Council meeting and send the Council meeting minutes back to the Department of Medicine Management;

d) Within eighteen working days from the date of receiving the Council meeting minutes, the Department of Medicine Management shall issue a decision to extend the drug registration certificate for files that meet the requirements; the Department of Medicine Management shall provide a written response according to the Council's conclusion for files that have not met the requirements and specify the reasons.

1a.[12] Within a maximum of three months from the date of receiving complete files, the Department of Medicine Management shall extend the drug registration certificate for cases specified in point c, Clause 2, Article 34 of this Circular. In case of non-extension or delay in extension, the Department of Medicine Management shall provide a written response specifying the reasons; the timeframes for each step are as follows:

a) Within seven working days from the date of receiving the file, the Department of Medicine Management shall review, classify, and send the file to the experts or units for assessment. Within one month from the date of receiving the file from the Department of Medicine Management, the experts or units for assessment must complete the assessment report and submit it to the Department of Medicine Management for consolidation and conclusion according to Clause 4, Article 35 of this Circular;

b) Within seven working days from the date of receiving the assessment report, the Department of Medicine Management shall provide a written response for files that have not met the requirements and specify the reasons;

c) Within fifteen days from the date of receiving the assessment report and for files that have met the requirements, the Department of Medicine Management shall issue a decision to extend the drug registration certificate.

2.[13] Within twelve months for cases supplementing documents, from the date the Department of Medicine Management issues a notification, the registering entity must submit supplementary documents as required. After this period, if the registering entity does not submit supplementary documents, the submitted file will lose its validity.

The registering entity shall notify the Department of Medicine Management in writing about the submitted file and the ongoing assessment process when updating information related to the safety and efficacy of the drug; legal documents of the registering entity, the drug manufacturing facility, and the raw material manufacturing facility; and the actual circulation status of the drug in Vietnam compared to the submitted file. The time taken for the registering entity to update information in writing is included in the processing time for supplementary documents.

The time from the issuance of the notification by the Department of Medicine Management to the submission of supplementary documents by the registering entity shall not be counted towards the deadline stipulated in point c, Clause 6, Article 56 of the Amended Drug Law under Clause 30, Article 1 of the Law Amending and Supplementing Certain Provisions of the Drug Law.

3.[14] Within three months from the date of receiving complete supplementary documents, the Department of Medicine Management shall issue a decision to extend the drug registration certificate for files that meet the requirements; provide a written response for files that have not met the requirements and specify the reasons. The procedure and timeframe for reviewing supplementary documents shall be carried out according to the provisions of Clause 1 and Clause 1a of this Article.

Article 38. Procedures for changing and supplementing the drug registration certificate during the validity period of the drug registration certificate

1. Changing and supplementing the drug registration certificate, except in cases provided for in Clause 2 of this Article

Within three months from the date of receipt of complete files, the Drug Administration shall approve the content of changes and supplements. In case of non-approval or delayed approval, the Drug Administration shall issue a written response stating the reasons. The timeframes for each step are specified as follows:

a) Within eight working days from the date of receipt of complete files, the Drug Administration shall review, classify, and forward the files to experts or evaluation units. Within one month from the date of receiving the files from the Drug Administration, the experts and evaluation units must complete the evaluation report and submit it to the Drug Administration for consolidation and conclusion according to Clause 4 of Article 35 of this Circular;

b) Within twelve working days from the date of receipt of the evaluation report from the experts or evaluation units, the Drug Administration shall issue a written response to the unsatisfactory evaluation files and state the reasons. For satisfactory evaluation files or other cases requiring the opinion of the Council, the Drug Administration shall transfer the files to the Council Office to convene a meeting of the Council;

c) Within six working days from the date of receipt of materials from the Drug Administration, the Council Office shall convene a Council meeting and issue a Council meeting record to be sent to the Drug Administration;

d) Within eighteen working days from the date of receipt of the Council meeting record, the Drug Administration shall publish the original brand name, reference biological product, and biosimilar drugs with bioequivalence reports, approve the content of changes and supplements, or issue a written response based on the Council's conclusions for unsatisfactory evaluation files and state the reasons.

2. Changing and supplementing the drug registration certificate for minor content changes that only require notification (Notification):

Within fifteen working days from the date of receipt of complete files, the Drug Administration shall classify and publish minor content changes that only require notification on its electronic information website. If the content of changes and supplements does not comply with minor content changes that only require notification, the Drug Administration shall issue a notification.

The entity is responsible for implementing and fully accountable for the content of changes and supplements from the date recorded on the file receipt form. The drug registration entity and the manufacturing entity are legally responsible for the accuracy and truthfulness of the information for changes and supplements that only require notification, and must retain relevant files and documents for post-market inspection by competent authorities.

Within thirty-six months for cases requiring preclinical and clinical data, bioequivalence data, stability study data, or within twelve months for other supplementary data, from the date the Drug Administration issues a notification, the drug registration entity must submit supplementary data as required. After this period, if the drug registration entity fails to submit supplementary data, the submitted file will lose its value.

The applicant is permitted to update in writing to the Department of Medicines Management about the submitted registration file and during the review period for cases updating information related to the safety and efficacy of drugs or legal documents of the applicant, drug manufacturing facility, or raw material production facility compared to the previously submitted file.

The time from the date of the Department of Medicines Management's notification to the date the applicant submits supplementary materials shall not be included in the timeframe specified in Clause 5, Article 56 of the Medicine Law.

4. Within two months from the date of receipt of complete supplementary data for the files stipulated in Clause 1 of this Article, the Drug Administration shall approve changes and supplements for files that meet requirements; issue a written response for unsatisfactory evaluation files and state the reasons. The timeframes for each step are specified as follows:

a) Within five working days from the date of receipt of complete files, the Drug Administration shall review, classify, and forward the files to the evaluation experts or evaluation units. Within eight working days from the date of receiving the files from the Drug Administration, the evaluation experts or evaluation units must complete the evaluation report and submit it to the Drug Administration for consolidation and conclusion according to Clause 4 of Article 35 of this Circular;

b) Within seven working days from the date of receipt of the evaluation report from the evaluation experts or evaluation units, the Drug Administration shall issue a written response to unsatisfactory evaluation files and state the reasons. For satisfactory evaluation files or other cases requiring the opinion of the Council, the Drug Administration shall transfer the files to the Council Office to convene a meeting of the Council;

c) Within six working days from the date of receiving materials from the Department of Medicine Management, the Council Office shall organize a Council meeting and send the Council meeting minutes back to the Department of Medicine Management;

d) Within eighteen working days from the date of receipt of the Council meeting record, the Drug Administration shall publish the original brand name, reference biological product, and biosimilar drugs with bioequivalence reports; approve the content of changes and supplements for satisfactory files. The Drug Administration shall issue a written response based on the Council's conclusions for unsatisfactory evaluation files and state the reasons.

5. The deadline for implementing changes and supplements to the drug registration certificate: not exceeding twelve months from the date the Drug Administration signs and issues the approval letter for changes and supplements.

6. Some cases of changes and supplements where the drug registration entity and the drug manufacturing entity are responsible for updating on the label and instructions for use without submitting a file or notifying the Drug Administration, including the following cases:

a) Implementing labeling and instructions for use of drugs according to Clause 2 of Article 35 of Circular 01/2018/TT-BYT dated January 18, 2018, issued by the Minister of Health regarding labeling of drugs and medicinal ingredients and the instruction leaflet for drugs;

b) Implementing changes and supplements to the content of labels and instructions for use of drugs according to the guidance document of the Drug Administration reflecting the Council's policy;

c) Apart from the cases where the label and instructions for use of drugs must be resubmitted when there are changes and supplements according to Appendix II attached to this Circular, other changes related to information on the label and instructions for use of drugs, the registration entity and the manufacturing entity must update them after the Drug Administration has approved these changes and supplements.

d) Other contents:

- Changing the position or information on the drug import label or drug usage instructions;

- Correcting typographical errors on the drug label or drug usage instructions;

- Changing the layout of the sections in the drug usage instructions without altering the content of the approved drug usage instructions;

- Adding quality standard information on the drug label or drug usage instructions according to the dossier approved by the Drug Administration Department;

- Removing non-mandatory information from the drug label or drug usage instructions.

Article 39. The procedure for issuing a drug circulation registration certificate shall be carried out according to the expedited review process, abbreviated review process, and issuance of a raw material drug circulation registration certificate.

1. Within six months from the date of receiving all necessary documents, the Drug Administration Department shall issue a drug circulation registration certificate. In cases where issuance is not granted or delayed, the Drug Administration Department shall provide a written response with specific reasons. The timeframes for each step are specified as follows:

a) Within sixteen working days from the date of receiving all necessary documents, the Drug Administration Department shall classify and forward the dossier to experts or reviewing units. Within three months from the date of receiving the dossier from the Drug Administration Department, the experts and reviewing units must complete the review report and submit it to the Drug Administration Department for consolidation and conclusion in accordance with Clause 4, Article 35 of this Circular;

b) Within eighteen working days from the date of receiving the review report, the Drug Administration Department shall provide a written response to dossiers that do not meet the requirements and specify the reasons. For dossiers that meet the requirements, do not meet the requirements, or other cases requiring the opinion of the Advisory Council for Drug Registration, the Drug Administration Department shall transfer the dossier to the Council's Office to convene a meeting of the Council;

c) Within ten working days from the date of receiving materials from the Drug Administration Department, the Council's Office shall convene a meeting of the Council and send the Council meeting minutes back to the Drug Administration Department;

d) Within one month from the date of receiving the Council meeting minutes, the Department of Medicines Management shall issue a decision to issue a drug registration certificate for files that meet the requirements; the Department of Medicines Management shall provide a written response according to the Council's conclusion for files that have not met the requirements, not met, and clearly state the reasons.

2. Within thirty-six months for cases requiring additional preclinical and clinical data, bioequivalence data, stability study data, or within twelve months for other cases requiring additional data, from the date the Department of Medicines Management issues a notification, the applicant must submit supplementary materials as required. After this period, if the applicant does not submit supplementary materials, the submitted file will lose its validity.

The applicant is permitted to update in writing to the Department of Medicines Management about the submitted registration file and during the review period for cases updating information related to the safety and efficacy of drugs or legal documents of the applicant, drug manufacturing facility, or raw material production facility compared to the previously submitted file.

The time from the date of the Department of Medicines Management's notification to the date the applicant submits supplementary materials shall not be included in the timeframe specified in Clause 5, Article 56 of the Medicine Law.

3. Within three months from the date of receiving supplementary materials, the Drug Administration Department shall issue a decision to grant a drug circulation registration certificate for dossiers that meet the requirements; the Drug Administration Department shall provide a written response based on the Council's conclusion for dossiers that do not meet the requirements and specify the reasons. The timeframes for each step are specified as follows:

a) Within ten working days from the date of receiving the dossier, the Drug Administration Department shall conduct a review, classification, and forward the dossier to reviewing experts or units. Within sixteen working days from the date of receiving the dossier from the Drug Administration Department, the reviewing experts or units must complete the review report and submit it to the Drug Administration Department for consolidation and propose opinions on the review report in accordance with Clause 4, Article 35 of this Circular;

b) Within eight working days from the date of receiving the review report, the Drug Administration Department shall provide a written response to dossiers that do not meet the requirements and specify the reasons. For dossiers proposed for issuance, non-issuance, or requiring the opinion of the Council, the Drug Administration Department shall transfer the dossier to the Council's Office to convene a meeting of the Council;

c) Within ten working days from the date of receiving materials from the Drug Administration Department, the Council's Office shall convene a meeting of the Council and send the Council meeting minutes back to the Drug Administration Department;

d) Within one month from the date of receiving the Council meeting minutes, the Department of Medicines Management shall issue a decision to issue a drug registration certificate for files that meet the requirements; the Department of Medicines Management shall provide a written response according to the Council's conclusion for files that have not met the requirements, not met, and clearly state the reasons.

Chapter V

WITHDRAWAL OF DRUG CIRCULATION REGISTRATION CERTIFICATE, SUSPENSION OF APPLICATION FOR REGISTRATION, EXTENSION OF DRUG CIRCULATION REGISTRATION CERTIFICATE

Article 40. Competence and Procedures for Revoking Drug Registration Certificates

1. Competence to revoke and responsibility to notify revocation of drug registration certificates:

a) The Department of Medicines Management shall revoke drug registration certificates in cases prescribed in Clause 1, Article 58 of the Medicine Law;

b) Provincial Health Departments under the central government and health departments of sectors shall notify decisions of the Department of Medicines Management regarding the revocation of drug registration certificates within their jurisdiction.

2. Procedures for revoking drug registration certificates as stipulated in points a and b of Clause 1, Article 58 of the Medicine Law:

Within thirty days from the date of the decision to revoke drugs by the competent authority, the Department of Medicines Management shall issue a decision to revoke drug registration certificates.

3. Procedures for revoking drug registration certificates as stipulated in points d and e of Clause 1, Article 58 of the Medicine Law:

Within thirty days from the date of the conclusion in writing by the competent authority that the drug registration application file is a false document or that the drug or raw materials were produced at an address not specified in the registration file, the Department of Medicines Management shall issue a decision to revoke drug registration certificates.

4. Procedures for revoking drug registration certificates as stipulated in points c and e of Clause 1, Article 58 of the Medicine Law:

Within ten days from the date the competent authority of Vietnam or from the date of receipt of a notification from WHO or the country of origin recommending that the drug is unsafe or ineffective for users, or from the date of receipt of a notification from a foreign competent authority revoking product certification, the Department of Medicines Management shall issue a decision to revoke drug registration certificates.

5. Procedures for revoking drug registration certificates as stipulated in point g of Clause 1, Article 58 of the Medicine Law:

a) The entity submits a request for revocation of drug registration certificates in Vietnam by the manufacturing entity or the registering entity according to Form 1/TT issued together with this Circular;

b) Within twenty days from the date of receipt of the revocation request, the Department of Medicines Management shall issue a decision to revoke drug registration certificates.

Article 41. Provisions on Suspension of Acceptance of Applications for Issuance and Extension of Drug Registration Certificates

1. Suspension of acceptance of applications for issuance and extension of drug registration certificates shall be implemented in accordance with the provisions of Clauses 2, 3, and 4 of Article 100 of Decree No. 54/2017/NĐ-CP.

2. The Department of Medicines Management shall announce the suspension of acceptance of applications for issuance and extension of drug registration certificates.

Chapter VI

PRINCIPLES OF ORGANIZATION AND OPERATION OF THE ADVISORY BOARD FOR ISSUING DRUG REGISTRATION CERTIFICATES, REVIEWING UNITS, AND REVIEW EXPERTS

Article 42. Organization and Operation of the Advisory Board

1. The Minister of Health shall establish the Advisory Board for issuing drug registration certificates. Members of the Board shall be experts with appropriate professional qualifications and experience to ensure the ability to review files, provide critical opinions on the views of review experts, proposals of the Department of Medicines Management, and advise the Minister of Health on issues related to pharmaceutical regulations, quality, safety, and efficacy of drugs and raw materials.

2. The Board shall have the responsibility to advise the Minister of Health on issuing, extending, changing, and supplementing drug registration certificates; granting import permits for drugs without registration certificates in Vietnam based on the results of expert reviews, proposals of the Department of Medicines Management, and other issues requested by the Minister of Health. The Board shall be responsible to the Minister of Health for its advisory opinions.

3. Principles of operation of the Board:

a) The Board operates on the principle of consensus, democratic concentration, objectivity, transparency, and openness. Opinions of the Board must be legally and scientifically grounded, taking into account the results of expert reviews, practical clinical evidence, and proposals of the Department of Medicines Management;

b) The Board shall convene when at least two-thirds of the Board members who meet the conditions (as per the organizational operation rules of the Board issued by the Ministry of Health) attend, and in cases where Board members do not attend but submit written opinions, they shall be considered as having attended the meeting;

The Chairman of the Board or a person authorized by the Chairman shall chair the meeting and conclude based on at least two-thirds of the opinions of attending members agreeing. Dissenting opinions shall be retained.

Opinions of Board members and conclusions of the Board must be recorded in the minutes of the Board meeting, including dissenting opinions.

c) In cases where the Board does not convene, the Chairman of the Board shall solicit opinions in writing from Board members;

If the deadline for soliciting opinions has passed, the Chairman of the Board or a person authorized shall make a conclusion of the Board when at least two-thirds of the members have submitted their opinions to the Board's Standing Committee for consolidation.

The Board's conclusion shall be based on the consensus of at least two-thirds of the members who have submitted their opinions to the Board's Standing Committee and on the basis of a consolidated report and proposal of the Department of Medicines Management;

The Board's conclusion shall be reflected in the Presentation Report recording the conclusion of the Chairman of the Board or of a person authorized by the Chairman.

d) In necessary cases, Board members have the right to examine and review files, and the Chairman of the Board may seek additional opinions from independent experts outside the Board before making a final conclusion. These experts may directly participate in the Board meeting or provide written opinions, having responsibilities and rights like formal Board members;

đ) Not violating principles of conflict of interest.

4. The Drug Administration Department shall advise the Minister of Health to promulgate regulations on the organization and operation of the Council, and the coordination mechanism between the Council and the experts during the process of issuing, renewing, changing, and supplementing drug registration certificates, raw material registration certificates for drugs, and import permits for drugs not yet registered in Vietnam.

5. The operating funds of the Council shall be implemented in accordance with the provisions of the law.

6. The Council's permanent office shall be located at the Drug Administration Department.

Article 43. Organization and activities of the evaluation unit, evaluation experts for applications for issuance, renewal, change, and supplementation of drug registration certificates, raw material registration certificates for drugs, and evaluation of applications for import permits for drugs not yet registered.

1. The Drug Administration Department and the evaluation unit shall be responsible for establishing specialized expert sub-committees: legal affairs; quality standards; pharmacology; clinical trials; formulation and stability; bioequivalence; and lists of experts in these sub-committees for evaluating applications for issuance, renewal, change, and supplementation of drug registration certificates, raw material registration certificates for drugs, and evaluations of applications for import permits for drugs not yet registered. The structure of the specialized expert sub-committees must be appropriate to the classification of the products being registered and the form of registration, or the products applying for import permits and the form of application for import permits.

2. Evaluation experts shall operate under the principle that all evaluation opinions must be based on legal grounds and scientific foundations and must be reflected in the minutes of the evaluation of applications for issuance, renewal, change, and supplementation of drug registration certificates, raw material registration certificates for drugs, or the minutes of the evaluation of applications for import permits for drugs not yet registered. Evaluation experts shall be accountable to the Director of the Drug Administration Department and to the evaluation unit regarding the contents of the evaluations and recommendations related to the evaluation of applications for issuance, renewal, change, and supplementation of drug registration certificates, raw material registration certificates for drugs, and evaluations of applications for import permits for drugs not yet registered.

3. Cục Quản lý Dược căn cứ chức năng, nhiệm vụ được giao xây dựng và ban hành quy chế tổ chức và hoạt động của các nhóm chuyên gia thẩm định (bao gồm cả chuyên gia của đơn vị thẩm định) hồ sơ đề nghị cấp, gia hạn, thay đổi, bổ sung thuốc, nguyên liệu làm thuốc, hồ sơ nhập khẩu thuốc chưa có giấy đăng ký lưu hành; ký hợp đồng với chuyên gia thẩm định hoặc đơn vị thẩm định hồ sơ;

Cục Quản lý Dược, đơn vị thẩm định tổ chức các khoá tập huấn, đào tạo cho chuyên gia thẩm định; tiến hành đánh giá năng lực chuyên môn của chuyên gia thẩm định do đơn vị thành lập và sự tuân thủ các quy định để có điều chỉnh, bổ sung chuyên gia thẩm định phù hợp.

4. Kinh phí tổ chức thẩm định hồ sơ được thực hiện theo quy định của pháp luật.

Chương VII

ĐIỀU KHOẢN THI HÀNH

Điều 44. Hiệu lực thi hành[15]

1. Thông tư này có hiệu lực thi hành kể từ ngày 20 tháng 10 năm 2022

2. Bãi bỏ các quy định sau:

a) Thông tư số 32/2018/TT-BYT ngày 12 tháng 11 năm 2018 của Bộ trưởng Bộ Y tế quy định việc đăng ký thuốc;

b) Khoản 3 Điều 1 Thông tư số 23/2021/TT-BYT ngày 09 tháng 12 năm 2021 của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số văn bản quy phạm pháp luật do Bộ trưởng Bộ Y tế ban hành;

c) Khoản 5 Điều 1 Thông tư số 29/2020/TT-BYT ngày 31 tháng 12 năm 2020 của Bộ trưởng Bộ Y tế sửa đổi, bổ sung và bãi bỏ một số văn bản quy phạm pháp luật do Bộ trưởng Bộ Y tế ban hành, liên tịch ban hành;

d) Điểm h khoản 3 Điều 14 Thông tư số 01/2018/TT-BYT ngày 18 tháng 01 năm 2018 của Bộ trưởng Bộ Y tế quy định ghi nhãn thuốc, nguyên liệu làm thuốc và tờ hướng dẫn sử dụng thuốc.

Điều 45. Điều khoản chuyển tiếp[16]

1. Các hồ sơ đã nộp trước thời điểm Thông tư này có hiệu lực thi hành được tiếp tục thực hiện theo quy định tại thời điểm nộp hồ sơ, trừ trường hợp cơ sở đăng ký tự nguyện thực hiện theo quy định kể từ ngày ký ban hành Thông tư này.

2. Các hồ sơ đã nộp cho cơ quan tiếp nhận hồ sơ trước ngày Thông tư này có hiệu lực nhưng đang trong quá trình giải quyết được áp dụng theo quy định có liên quan tại Thông tư này hoặc các quy định trước ngày Thông tư này có hiệu lực theo hướng thuận tiện cho doanh nghiệp, tổ chức, cá nhân.

3. Thuốc được nộp hồ sơ đăng ký theo các quy định trước ngày Thông tư số 32/2018/TT-BYT có hiệu lực và được cấp giấy đăng ký lưu hành hoặc gia hạn giấy đăng ký lưu hành, cơ sở chỉ được sản xuất thuốc thành phẩm từ nguyên liệu làm thuốc sản xuất bởi các cơ sở sản xuất đáp ứng thực hành tốt sản xuất với phạm vi phù hợp theo đúng quy định tại Điều 141 Nghị định số 54/2017/NĐ-CP. Cơ sở sản xuất và cơ sở đăng ký phải lưu trữ tài liệu chứng minh theo quy định tại khoản 11 Điều 22 Thông tư này và xuất trình cho các cơ quan có thẩm quyền liên quan khi có yêu cầu.

4. Việc đăng ký lưu hành vắc xin phòng Covid - 19 trong trường hợp cấp bách thực hiện theo quy định tại Thông tư số 11/2021/TT-BYT ngày 19 tháng 8 năm 2021 của Bộ trưởng Bộ Y tế hướng dẫn đăng ký lưu hành vắc xin phòng Covid - 19 trong trường hợp cấp bách.

5. Trường hợp WHO công bố mẫu CPP cập nhật, trong thời hạn 12 tháng kể từ ngày mẫu CPP cập nhật được còng bố trên trang thông tin điện tử của WHO, cơ sở đăng ký phải nộp CPP có đủ nội dung theo mẫu CPP cập nhật trong hồ sơ đăng ký thuốc. Chấp nhận đối với CPP chưa cập nhật (mẫu cũ) nếu CPP còn hiệu lực tại thời điểm tiếp nhận hồ sơ đăng ký thuốc.

6. Nội dung liên quan đến cơ quan quản lý nước tham chiếu quy định tại khoản 9 Điều 2 Thông tư số 32/2018/TT-BYT được dẫn chiếu tại văn bản quy phạm pháp luật khác được tiếp tục thực hiện đến khi văn bản quy phạm pháp luật đó được sửa đổi, bổ sung, thay thế hoặc bãi bỏ.

7. Trường hợp thuốc đã được Bộ Y tế công bố biệt dược gốc trước thời điểm Thông tư này có hiệu lực, giao Cục Quản lý Dược thực hiện điều chỉnh, cập nhật thay đổi, bổ sung thông tin đã công bố biệt dược gốc theo đề nghị của cơ sở đăng ký thuốc.

8. Trường hợp Phụ lục I, III, IV ban hành kèm theo Thông tư này cập nhật theo những yêu cầu kỹ thuật chung Asean, trong thời hạn 06 tháng kể từ ngày các tài liệu cập nhật được công bố trên Cổng thông tin điện tử của Asean (https://asean.org/our-communities/economic-community/standard-and-comformance/key-documents-publications/), Cục Quản lý Dược tổ chức dịch và công bố nội dung cập nhật trên Cổng thông tin điện tử của Bộ Y tế và Trang thông tin điện tử của Cục Quản lý Dược.

Trong thời hạn 06 tháng kể từ ngày Cục Quản lý Dược công bố nội dung cập nhật trên Cổng thông tin điện tử của Bộ Y tế và Trang thông tin điện tử của Cục Quản lý Dược, cơ sở đăng ký, cơ sở sản xuất phải cập nhật trong hồ sơ đăng ký thuốc.

9. Thuốc đăng ký sản xuất tại Việt Nam theo hình thức chuyển giao công nghệ, thuốc thực hiện đóng gói thứ cấp tiếp tục thực hiện theo quy định tại Thông tư 32/2018/TT-BYT đến khi Thông tư quy định việc đăng ký lưu hành đối với thuốc gia công, thuốc chuyển giao công nghệ tại Việt Nam của Bộ Y tế được ban hành và có hiệu lực thi hành.

Điều 46. Lộ trình thực hiện

1. Kể từ ngày Thông tư này có hiệu lực thi hành, cơ sở sản xuất có nhiều hơn 02 thuốc có cùng dược chất hoặc thành phần dược liệu, dạng bào chế, đường dùng, hàm lượng hoặc nồng độ trong một đơn vị phân liều đã được cấp giấy đăng ký lưu hành, khi nộp hồ sơ đề nghị gia hạn giấy đăng ký lưu hành, cơ sở sản xuất phối hợp với cơ sở đăng ký thuốc lựa chọn và đề nghị gia hạn giấy đăng ký lưu hành cho 2 thuốc theo quy định tại khoản 6 Điều 8 Thông tư này, các thuốc đã được cấp giấy đăng ký lưu hành còn lại sẽ được gia hạn hiệu lực giấy đăng ký lưu hành đến hết ngày 31/12/2025.

2. Đối với thuốc, nguyên liệu làm thuốc sản xuất trong nước đã được cấp giấy đăng ký lưu hành trước ngày Thông tư này có hiệu lực thi hành và cơ sở có nhu cầu nhập khẩu nguyên liệu làm thuốc là tá dược, vỏ nang về Việt Nam: Trước khi nhập khẩu lần đầu về Việt Nam, cơ sở đăng ký cập nhật toàn bộ thông tin về nguyên liệu làm thuốc là tá dược, vỏ nang trong hồ sơ đã được phê duyệt lên hệ thống dịch vụ công trực tuyến của Cục Quản lý Dược. Trong thời gian 05 ngày làm việc kể từ ngày cơ sở cập nhật thông tin lên hệ thống, Cục Quản lý Dược phải hoàn thành việc công bố. Cơ sở đăng ký chịu trách nhiệm về tính chính xác của thông tin cập nhật so với thông tin trong hồ sơ đăng ký đã được phê duyệt và không bắt buộc phải cập nhật lại thông tin ở lần nhập khẩu tiếp theo.

3. Việc áp dụng số đăng ký theo cấu trúc quy định tại Phụ lục VI ban hành kèm theo Thông tư này khi cấp mới, gia hạn giấy đăng ký lưu hành thực hiện kể từ ngày 01 tháng 01 năm 2023. Đối với thuốc đã được cấp số đăng ký trước ngày 01 tháng 01 năm 2023 được gia hạn giấy đăng ký lưu hành thì được tiếp tục sử dụng số đăng ký đã cấp trước khi gia hạn trong thời hạn tối đa 12 tháng kể từ ngày được cấp số đăng ký theo cấu trúc quy định tại Phụ lục VI ban hành kèm theo Thông tư này.

Điều 47. Điều khoản tham chiếu

Trong trường hợp các văn bản quy phạm pháp luật và các quy định được viện dẫn trong Thông tư này có sự sửa đổi, bổ sung hoặc được thay thế thì áp dụng theo văn bản quy phạm pháp luật mới.

Điều 48. Trách nhiệm thi hành[17]

1. Cục Quản lý Dược căn cứ chức năng, nhiệm vụ được giao và lộ trình hòa hợp ASEAN trong đăng ký thuốc, có trách nhiệm:

a) Tổ chức hướng dẫn và thực hiện các quy định của Thông tư này;

b) Cập nhật danh mục các thuốc, nguyên liệu làm thuốc được cấp, gia hạn giấy đăng ký lưu hành trong thời hạn 05 ngày kể từ ngày cấp, gia hạn giấy đăng ký lưu hành và các thông tin đăng ký thuốc, nguyên liệu làm thuốc khác trên trang thông tin điện tử của Cục Quản lý Dược;

c) Công bố, cập nhật danh mục các thuốc có chứng minh tương đương sinh học, thuốc được công bố biệt dược gốc, sinh phẩm tham chiếu trong thời hạn 05 ngày kể từ ngày cấp giấy đăng ký lưu hành và các thông tin thay đổi, bổ sung của thuốc có chứng minh tương đương sinh học, thuốc được công bố biệt dược gốc, sinh phẩm tham chiếu trong thời hạn 07 ngày kể từ ngày phê duyệt thay đổi, bổ sung giấy đăng, ký lưu hành thuốc trên trang thông tin điện tử của Cục Quản lý Dược;

d) Xem xét, rà soát thuốc có chứng minh tương đương sinh học, thuốc đã được công bố biệt dược gốc, sinh phẩm tham chiếu không còn đáp ứng các tiêu chí theo quy định;

đ) Xây dựng, ban hành tổ chức triển khai thực hiện các quy trình chuẩn (SOPs) trong đăng ký thuốc và sổ tay hướng dẫn đăng ký thuốc (QM);

e) Phối hợp với Cục Quản lý Y, Dược cổ truyền trong việc gia hạn, thay đổi, bổ sung giấy đăng ký lưu hành thuốc cổ truyền, dược liệu đã được cấp giấy đăng ký lưu hành theo quy định tại Thông tư số 44/2014/TT-BYT ngày 25 tháng 11 năm 2014 của Bộ trưởng Bộ Y tế quy định việc đăng ký thuốc;

g) Trường hợp cơ sở đăng ký thuốc có hành vi giả mạo hoặc tự ý sửa chữa hồ sơ, tài liệu, giấy tờ pháp lý của các cơ quan chức năng của Việt Nam hoặc của nước ngoài; sử dụng con dấu giả hoặc giả mạo chữ ký hoặc dấu của cơ sở đăng ký, cơ sở sản xuất và các cơ sở liên quan trong hồ sơ đăng ký thuốc thì Cục Quản lý Dược sẽ có công văn cảnh báo cơ sở và ngừng nhận hồ sơ cấp, gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc theo quy định tại khoản 2, 3 và 4 Điều 100 Nghị định 54/2017/NĐ-CP ngày 08 tháng 5 năm 2017 của Chính phủ quy định chi tiết một số điều và biện pháp thi hành Luật Dược.

Ngoài các hình thức trên, Cục Quản lý Dược công khai nội dung vi phạm của cơ sở trên trang thông tin điện tử của Cục Quản lý Dược, đồng thời thông báo tới cơ quan Thanh tra và các cơ quan chức năng có thẩm quyền để xem xét, xử lý theo quy định của pháp luật;

h) Trường hợp cơ sở sản xuất thuốc có hành vi giả mạo hoặc tự ý sửa chữa hồ sơ, tài liệu, giấy tờ pháp lý của các cơ quan chức năng của Việt Nam hoặc của nước ngoài; cung cấp hồ sơ cho cơ sở đăng ký thuốc để đăng ký lưu hành tại Việt Nam không dựa trên nghiên cứu, sản xuất thực tế thì Cục Quản lý Dược sẽ có công văn cảnh báo cơ sở và ngừng nhận hồ sơ cấp, gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc theo quy định tại khoản 2, 3 và 4 Điều 100 Nghị định 54/2017/NĐ-CP ngày 08 tháng 5 năm 2017 của Chính phủ quy định chi tiết một số điều và biện pháp thi hành Luật Dược.

Ngoài các hình thức trên, Cục Quản lý Dược công khai nội dung vi phạm của cơ sở trên trang thông tin điện tử của Cục Quản lý Dược, đồng thời thông báo tới cơ quan Thanh tra và các cơ quan chức năng có thẩm quyền để xem xét, xử lý theo quy định của pháp luật;

i) Trong trường hợp cần thiết, Cục Quản lý Dược tổ chức cuộc họp với cơ sở đăng ký, cơ sở sản xuất, chuyên gia thẩm định nhằm làm rõ các vướng mắc liên quan đến việc thẩm định hồ sơ đăng ký thuốc, nguyên liệu làm thuốc;

k) Công bố trên trang thông tin điện tử của Cục Quản lý Dược danh mục các cơ sở đăng ký, cơ sở sản xuất thuốc, nguyên liệu làm thuốc theo quy định tại khoản 10, 14 Điều 22 Thông tư này;

l) Xây dựng quy định việc áp dụng mã vạch (Bar code), mã QR, mã DataMatrix Code (DMC) trên bao bì ngoài của thuốc, nguyên liệu làm thuốc của các cơ sở sản xuất nhằm quản lý, nhận diện, truy xuất nguồn gốc thuốc, nguyên liệu làm thuốc lưu hành trên thị trường và lộ trình thực hiện theo quy định của Bộ trưởng Bộ Y tế;

m) Trong thời hạn 30 ngày kể từ ngày cấp, gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc, Cục Quản lý Dược trả nhãn, hướng dẫn sử dụng thuốc cho cơ sở đăng ký;

n) Trong thời hạn 15 ngày kể từ ngày cấp, gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc, 07 ngày kể từ ngày phê duyệt thay đổi, bổ sung giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc, Cục Quản lý Dược công bố nguồn nguyên liệu làm thuốc đối với các thuốc sản xuất tại Việt Nam trên trang thông tin điện tử của Cục Quản lý Dược.

o)[18] Trong thời hạn 03 ngày làm việc kể từ ngày tiếp nhận hồ sơ đề nghị gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc, Cục Quản lý Dược công khai thông tin tiếp nhận hồ sơ đề nghị gia hạn giấy đăng ký lưu hành trên Cổng thông tin điện tử của Bộ Y tế, Trang thông tin điện tử Cục Quản lý Dược;

p)[19] Trong thời hạn 03 ngày làm việc kể từ ngày Cục Quản lý Dược có văn bản thông báo không gia hạn hoặc thông báo tạm dừng sử dụng giấy đăng ký lưu hành do phát hiện thuốc, nguyên liệu làm thuốc có nguy cơ không an toàn cho người sử dụng hoặc nghi ngờ giả mạo tài liệu pháp lý, Cục Quản lý Dược công khai thông tin trên Cổng thông tin điện tử của Bộ Y tế, Trang thông tin điện tử Cục Quản lý Dược.

2. Sở Y tế các tỉnh, thành phố trực thuộc Trung ương chịu trách nhiệm kiểm tra, thanh tra việc thực hiện Thông tư này đối với các đơn vị sản xuất, kinh doanh dược phẩm trong phạm vi quản lý.

3. Các đơn vị trực thuộc Bộ Y tế, Tổng Công ty Dược Việt Nam - CTCP, các cơ sở kinh doanh thuốc có trách nhiệm thực hiện Thông tư này.

Trong quá trình thực hiện nếu có khó khăn, vướng mắc, các cơ quan, tổ chức, cá nhân phản ánh về Bộ Y tế (Cục Quản lý Dược) để xem xét giải quyết./.

 

 

 

[1] Thông tư số 55/2024/TT-BYT ngày 31 tháng 12 năm 2024 của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc có căn cứ ban hành như sau:

Căn cứ Luật Dược ngày 06 tháng 4 năm 2016;

Căn cứ Luật sửa đổi, bổ sung một số điều của Luật Dược ngày 21 tháng 11 năm 2024;

Căn cứ Nghị định số 54/2017/NĐ-CP ngày 08 tháng 5 năm 2017 của Chính phủ quy định chi tiết một số điều và biện pháp thi hành Luật Dược;

Căn cứ Nghị định số 155/2018/NĐ-CP ngày 12 tháng 11 năm 2018 của Chính phủ sửa đổi, bổ sung một số quy định liên quan đến điều kiện đầu tư kinh doanh thuộc phạm vi quản lý nhà nước của Bộ Y tế;

Căn cứ Nghị định số 88/2023/NĐ-CP ngày 11 tháng 12 năm 2023 của Chính phủ sửa đổi, bổ sung một số điều của Nghị định số 54/2017/NĐ-CP ngày 08 tháng 5 năm 2017 của Chính phủ quy định chi tiết một số điều và biện pháp thi hành Luật Dược và Nghị định số 155/2018/NĐ-CP ngày 12 tháng 11 năm 2018 của Chính phủ sửa đổi, bổ sung một số quy định liên quan đến điều kiện đầu tư kinh doanh thuộc phạm vi quản lý nhà nước của Bộ Y tế;

Căn cứ Nghị định số 95/2022/NĐ-CP ngày 15 ngày 11 năm 2022 của Chính phủ quy định chức năng, nhiệm vụ, quyền hạn và cơ cấu tổ chức của Bộ Y tế;

Theo đề nghị của Cục trưởng Cục Quản lý Dược;

Bộ trưởng Bộ Y tế ban hành Thông tư sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc.

[2] Điểm này được bãi bỏ tại khoản 11 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025

[3] Tiêu đề của khoản này được sửa đổi, bổ sung theo quy định tại điểm a khoản 1 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[4] Khoản này được bổ sung theo quy định tại điểm b khoản 1 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[5] Khoản này được sửa đổi, bổ sung theo quy định tại khoản 2 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[6] Khoản này được sửa đổi, bổ sung theo quy định tại khoản 3 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[7] Khoản này được sửa đổi, bổ sung theo quy định tại khoản 4 Điều 1 Thông tư số 55/2024//TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[8] Khoản này được sửa đổi, bổ sung theo quy định tại khoản 5 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[9] Điều này được sửa đổi, bổ sung theo quy định tại khoản 6 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[10] Tiết này được sửa đổi, bổ sung theo quy định tại khoản 7 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[11] Tiêu đề của khoản được sửa đổi, bổ sung theo quy định tại điểm a khoản 8 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[12] Khoản này được bổ sung theo quy định tại điểm b khoản 8 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[13] Khoản này được sửa đổi theo quy định tại điểm c khoản 8 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[14] Khoản này được sửa đổi theo quy định tại điểm d khoản 8 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[15] Điều 2 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025, quy định như sau:

“Điều 2. Hiệu lực thi hành

Thông tư này có hiệu lực thi hành từ ngày 01 tháng 01 năm 2025.”

[16] Điều 3 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025, quy định như sau:

“Điều 3. Điều khoản chuyển tiếp

Hồ sơ đề nghị gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc nộp trước ngày Thông tư này có hiệu lực thi hành nhưng chưa được gia hạn giấy đăng ký lưu hành thực hiện như sau:

1. Được tiếp tục sử dụng giấy đăng ký lưu hành của thuốc, nguyên liệu làm thuốc theo quy định tại điểm c khoản 8 Điều 56 Luật Dược được sửa đổi tại khoản 30 Điều 1 Luật sửa đổi, bổ sung một số điều của Luật Dược.

2. Được tiếp tục thẩm định, gia hạn giấy đăng ký lưu hành nếu đáp ứng quy định tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc; trường hợp cơ sở đề nghị thực hiện theo quy định của Thông tư này phải hoàn thiện hồ sơ theo quy định để được xem xét gia hạn giấy đăng ký lưu hành.”

[17] Điều 4 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025 quy định như sau:

“Điều 4. Trách nhiệm thi hành

Chánh Văn phòng Bộ, Cục trưởng Cục Quản lý Dược, Chánh Thanh tra Bộ, Thủ trưởng các đơn vị thuộc và trực thuộc Bộ Y tế; Giám đốc Sở Y tế các tỉnh, thành phố trực thuộc Trung ương; các cơ quan, tổ chức, cá nhân có liên quan chịu trách nhiệm thi hành Thông tư này.

Trong quá trình thực hiện, nếu có khó khăn, vướng mắc, đề nghị các cơ quan, tổ chức, cá nhân phản ánh về Bộ Y tế (Cục Quản lý Dược) xem xét, giải quyết./.”

[18] Điểm này được bổ sung theo quy định tại khoản 9 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025.

[19] Điểm này được bổ sung theo quy định tại khoản 9 Điều 1 Thông tư số 55/2024/TT-BYT của Bộ trưởng Bộ Y tế sửa đổi, bổ sung một số điều về gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư số 08/2022/TT-BYT ngày 05 tháng 9 năm 2022 của Bộ trưởng Bộ Y tế quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc, có hiệu lực kể từ ngày 01 tháng 01 năm 2025