Circular No. 08/2022/TT-BYT stipulates the registration for circulation of drugs and drug raw materials

✦ Tóm lược thông minh

This article compiles regulations on drug registration files and drug raw material registration files in Vietnam, including necessary legal documents such as certificates of eligibility to operate pharmaceutical businesses, licenses to establish representative offices, legal documents from foreign regulatory authorities, proof that production facilities meet Good Manufacturing Practice (GMP) standards for drug raw materials, proposed labels and usage instructions for circulation in Vietnam. The article also mentions that certain documents are not required to be submitted if the registering entity is listed on the website of the Drug Administration of Vietnam.

Đối tượng áp dụng

Entities registering drugs and drug raw materials in Vietnam

Các điểm cốt lõi

Requirements for legal documents from domestic and foreign regulatory authorities
Proof that production facilities meet GMP standards
Proposed labels and usage instructions for circulation in Vietnam
Conditions for exemption from submitting certain documents if listed on the published list of the Drug Administration of Vietnam
Regulations on authorization, signing on registration files

🌐 Tác động xã hội từ văn bản này

Ensuring quality and safety for drug users
Facilitating the importation and domestic production of drugs
Developing the pharmaceutical industry in Vietnam

❓ Câu hỏi thường gặp

Does the registering entity need to submit legal documents from foreign regulatory authorities?

For foreign registering entities, legal documents issued by competent foreign authorities granting permission to conduct at least one of the following business activities: manufacturing, wholesaling, exporting, or importing drugs and drug raw materials must be submitted.

Which entities are exempt from submitting legal documents?

If the registering entity is listed on the register of drug and drug raw material registrants published on the website of the Drug Administration of Vietnam, it is exempt from submitting the documents specified in Clauses 7, 8, and 9 of this Article.

What requirements are there for proposed labels and usage instructions for circulation in Vietnam?

Proposed labels and usage instructions must bear the confirmation stamp of the representative office or the registering entity or the production facility. The outer packaging labels of drugs and drug raw materials must have a barcode (Bar code), Quick Response (QR) code, or DataMatrix Code (DMC) printed on them.

Toàn văn

CIRCULAR

PROVISIONS ON THE REGISTRATION OF MEDICINES AND DRUG SUBSTANCES FOR CIRCULATION

Pursuant to the Medicine LawNo. 105/2016/QH13 dated April 6, 2016;

Pursuant to Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law;

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

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

The Minister of Health issues this Circular providing for the registration of medicines and drug substances for circulation.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Circular provides detailed regulations on:

a) Documents, procedures for issuing, extending, changing, supplementing, and revoking certificates for the circulation of chemical drugs, vaccines, biological products, traditional medicine drugs, and drug substances (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 the application for drug registration;

c) Criteria for determining cases exempt from testing, exempting certain 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 certificates for the circulation of medicines and drug substances;

đ) Principles of organization and operation of experts reviewing applications for importing medicines without certificates for circulation as prescribed in point a, Clause 43, Article 5 of Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions under the 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 certificates for the circulation of medicines and drug substances (hereinafter referred to as the Council);

g) Procedures for reviewing applications for issuing, extending, changing, and supplementing certificates for the circulation of medicines and drug substances; procedures for reviewing applications for importing medicines without certificates for circulation.

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

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 applications meeting the common technical requirements of the Association of Southeast Asian Nations (ASEAN) as stipulated in Appendix I attached hereto.

2. ICH-CTD Common Technical Document is a common application form of 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 affect very little the efficacy, quality, and safety of the drug, as defined in Appendix II attached hereto.

5. Drug Registration Applicant is the entity named in the application for issuing, extending, changing, and supplementing certificates for the circulation of medicines and drug substances.

6. Drug Manufacturing Facility is the entity carrying out one or several stages or the entire production process or performing the release of a batch of drugs.

7. Drug Substance Manufacturing Facility is the entity producing raw materials for finished drug products or the entity performing the release of a batch of drug substances.

8. Certificate of Pharmaceutical Product (CPP) (Code of Criminal Procedure) is a certificate issued according to the World Health Organization's (WHO) system for certifying the quality of pharmaceutical products circulating in international trade.

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

a) European Medicines Agency (EMA);

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

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

- Pre-October 23, 2015 ICH observer members, including: European Free Trade Association (EFTA) drug regulatory agency 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 Certificate of Pharmaceutical Product (CPP) issued according to WHO's model.

11. Semi-finished Traditional Medicine Product is raw material for producing traditional medicine drugs in the form of extract, powder, decoction, essential oil, resin, gum, jelly.

Article 3. Responsibilities of the drug registration entity

1. Shall be fully responsible under the law for the accuracy, legality, and honesty of all documents in the registration dossier. Cooperate with the production entity, competent authorities both domestically and internationally to respond 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.

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 written update request during the validity period of the drug marketing authorization without having to submit a change or supplement registration dossier.

4. Ensure that the quality, safety, and efficacy of drugs and drug ingredients comply 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 for the drug or drug ingredient at any country worldwide, if such authorization has been granted in Vietnam and specify 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 its 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 according to 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. 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 ingredients registered for circulation in Vietnam.

10. Coordinate with the production entity to update the quality standards of drugs and drug ingredients according to Circular No. 11/2018/TT-BYT dated May 4, 2018, of the Minister of Health on drug 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 for issuance or extension of the marketing authorization for vaccines.

12. Shall be responsible according to Clause 2, Article 57 of the Medicine Law and the provisions of this Article for drugs and drug ingredients from the date the Drug Administration signs the letter approving the change of the registration entity, including those drugs and drug ingredients 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 according to this Circular and other relevant laws.

Article 4. Responsibilities of Pharmaceutical Production Facilities

1. Must produce pharmaceuticals and drug raw materials at the correct facility with a production permit or business registration certificate for pharmaceuticals and drug raw materials issued by the competent authority.

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

3. Cooperate with the pharmaceutical registration facility, 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 production facility when requested by the competent authority.

4. Propose the revocation of the pharmaceutical registration for circulation certificate for pharmaceuticals and drug raw materials produced by the facility in cases where the quality, safety, and efficacy of the pharmaceuticals 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 production facility within the validity period of the pharmaceutical registration for circulation certificate.

6. In case the pharmaceutical registration facility does not meet the operating conditions as notified by the competent authority, the production facility may change the pharmaceutical registration facility within thirty days from the date of receipt of the notification document.

7. Update the quality standards of pharmaceuticals 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 production 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. Pharmaceutical businesses and medical examination and treatment facilities must implement monitoring, supervision, collection, synthesis, 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 Drug Law, national pharmacovigilance guidelines issued by the Ministry of Health, and relevant regulations.

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

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

b) When submitting an application for extension of the registration for circulation certificate to the Drug Administration Department.

3. Medical examination and treatment facilities using pharmaceuticals must report the situation of pharmaceutical use according to Form 2C/TT issued together with this Circular annually every six months during the validity period of the registration for circulation certificate for pharmaceuticals 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 synthesizing, 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. Fees for drug registration and raw material registration

The entity registering drugs and raw materials must pay fees related to drug and raw material registration in accordance with current laws on fees and charges.

Article 8. Validity period, designation of drug circulation registration certificate, and time limit for submitting extension registration applications; number of circulation registration certificates for drugs with the same active ingredient or herbal component, dosage form, route of administration, strength, or concentration in a single unit dose

1. The validity period of the drug circulation registration certificate is five (5) years from the date of issuance or extension, except in cases provided for in Clause 2 of this Article.

2. The validity period of the circulation registration certificate is three (3) years from the date of issuance for the following drugs:

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

b) Drugs with the same active ingredient, concentration, strength, and dosage form as new drugs that have not been issued a circulation registration certificate with a five (5)-year validity period;

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

d) Drugs specified in points a, b, and c of this clause but at the time of submitting an application for extending the circulation registration certificate, there is no safety and efficacy report due to non-circulation or limited usage quantity, patient number, and usage duration according to the Council's opinion or recommendations from healthcare facilities regarding the need for continued monitoring of safety and efficacy.

3. Each drug or raw material receiving a circulation registration certificate will be assigned a registration number structured as prescribed in Appendix VI attached to this Circular.

4. Time limit for submitting an extension registration application: Within twelve (12) months before the circulation registration certificate expires, the entity applying for registration must submit an extension registration application.

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. Number of circulation registration certificates for drugs produced by the same manufacturer with the same active ingredient or herbal component; dosage form; route of administration; strength 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 drugs and drugs manufactured solely for export.

Article 9. Criteria for classification and cases of announcing original brand-name drugs and reference biological products

1. Criteria for classifying original brand-name drugs and reference biological products

a) A drug issued a circulation registration certificate in Vietnam shall be classified as an original brand-name drug or reference biological product if it meets the following criteria simultaneously:

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

For reference biological products specifically, they must have complete files and data on quality, preclinical, and clinical aspects according to the development of a biological product from the beginning, not developed as a biosimilar;

- It is licensed for circulation by one of the regulatory authorities specified in Clause 9 of Article 2 of this Circular, except for newly produced drugs in Vietnam.

b) For drugs already announced as original brand-name drugs or reference biological products by the Ministry of Health, which subsequently undergo contract manufacturing or technology transfer of one, several, or all production stages at a drug manufacturing facility in Vietnam, the following criteria must be met simultaneously:

- Same formulation process;

- Same production process;

- Same raw material quality standards;

- Same finished product quality standards;

In case of changes to any of these criteria or other changes related to drug quality, 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 drug for circulation, or the entity applying for registration must provide data proving that the drug produced in Vietnam is equivalent in quality to the original brand-name drug or reference biological product before contract manufacturing or technology transfer.

c) If a drug already classified as an original brand-name drug or reference biological product changes its manufacturing site, the new circulation registration certificate issued by the changed manufacturing site will also be classified as an original brand-name drug or reference biological product based on a written request from the entity applying for registration if it meets the following criteria simultaneously:

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

- It meets the criteria stipulated in point b of Clause 1 of this Article simultaneously.

In case of changes to any of these criteria or other changes related to drug quality, 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 drug for circulation, or the entity applying for registration must provide data proving that the drug produced at the new site is equivalent in quality to the original brand-name drug or reference biological product before changing the manufacturing site.

2. Cases where drugs are classified as original brand-name drugs or reference biological products:

a) Drugs already announced as original brand-name drugs or reference biological products produced entirely in a country with a regulatory authority specified in Clause 9 of Article 2 of this Circular will continue to be classified as original brand-name drugs or reference biological products if they fall under any of the following circumstances:

- They have a valid circulation registration certificate or have been extended or modified without falling under the provisions of point b of Clause 2 of Article 55 of the Drug Law. The entity applying for registration does not need to submit an application for classification as an original brand-name drug or reference biological product.

- Medicines that are newly registered for circulation according to the re-registration procedure prescribed in Circular No. 44/2014/TT-BYT dated November 25, 2014, issued by the Minister of Health on the registration of medicines (hereinafter referred to as Circular No. 44/2014/TT-BYT), which have the same formulation, production process, quality standards of raw materials, and finished product quality standards compared to the original brand medicine or reference biological product already announced, or have changes related to the above content approved by the Drug Administration of Vietnam or the competent authority of the country where they are produced. The registration entity shall submit an updated classification application for the original brand medicine or reference biological product in accordance with Appendix II attached to this Circular.

- Medicines that change their place of production and are newly registered for circulation in compliance with the provisions set out in point c, Clause 1 of this Article. The registration entity shall submit an updated classification application for the original brand medicine or reference biological product in accordance with Appendix II attached to this Circular.

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

- Medicines that have a valid registration certificate for circulation, or have had their validity extended, or have undergone changes or supplements that do not fall within the scope of point b, Clause 2, Article 55 of the Medicine Law;

- Medicines that are newly registered for circulation according to the re-registration procedure prescribed in Circular No. 44/2014/TT-BYT, which have the same formulation, production process, quality standards of raw materials, and finished product quality standards compared to the original brand medicine or reference biological product already announced, or have changes related to the above content approved by the competent authority of Vietnam or the country where they are produced. The registration entity shall submit an updated classification application for the original brand medicine or reference biological product in accordance with Appendix II attached to this Circular.

- Medicines that change their place of production and are newly registered for circulation and comply with the provisions set out in point c, Clause 1 of this Article;

The registration entity shall submit an updated classification application for the original brand medicine or reference biological product in accordance with Appendix II attached to this Circular for the three cases mentioned above.

c) Medicines that have been announced by the Ministry of Health as original brand medicines or reference biological products, which are entirely produced in all stages in Vietnam or are produced in one or several stages in Vietnam and the remaining production stages are carried out entirely in a country whose regulatory authority is specified in Clause 9, Article 2 of this Circular, shall continue to be classified as original brand medicines or reference biological products if they fall under one of the following cases:

- Medicines that change their place of production and are newly registered for circulation and comply with the provisions set out in point c, Clause 1 of this Article. The registration entity shall submit an updated classification application for the original brand medicine or reference biological product in accordance with Appendix II attached to this Circular.

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

- Medicines that change their place of production and are newly registered for circulation and comply with the provisions set out in point c, Clause 1 of this Article;

đ) Medicines that have been announced by the Ministry of Health as original brand medicines or reference biological products, which are entirely produced in a country whose regulatory authority is specified in Clause 9, Article 2 of this Circular, and are processed or transferred technology for production in Vietnam, then the medicines processed or transferred technology for production in one, several, or all production stages in Vietnam and newly registered for circulation shall continue to be classified as original brand medicines or reference biological products if they comply with the provisions set out in point b, Clause 1 of this Article. The registration entity placing processing or transferring technology for production in Vietnam shall submit an updated classification application for the original brand medicine or reference biological product in accordance with Appendix II attached to this Circular.

e) Medicines that have been announced by the Ministry of Health as original brand medicines or reference biological products, which are not entirely produced in a country whose regulatory authority is specified in Clause 9, Article 2 of this Circular, but are permitted to circulate in a country whose regulatory authority is specified in Clause 9, Article 2 of this Circular, and are processed or transferred technology for production in Vietnam, then the medicines processed or transferred technology for production in one, several, or all production stages in Vietnam and newly registered for circulation shall continue to be classified as original brand medicines or reference biological products if they comply with the provisions set out in point b, Clause 1 of this Article. The registration entity processing or transferring technology for production in Vietnam shall submit an updated classification application for the original brand medicine or reference biological product in accordance with Appendix II attached to this Circular.

g) Medicines that have not been announced by the Ministry of Health as original brand medicines or reference biological products, if they comply with the provisions set out in point a, Clause 1 of this Article, shall be classified as original brand medicines or reference biological products. The registration entity shall submit an updated classification application for the original brand medicine or reference biological product in accordance with Appendix II attached to this Circular.

Article 10. Criteria for classifying drugs with bioequivalence proven

Drugs registered for circulation in Vietnam shall be classified as drugs with bioequivalence proven when they have a bioequivalence report that meets the Ministry of Health's regulations on drugs required to undergo bioequivalence testing and the requirements for filing bioequivalence research data in drug circulation registration in Vietnam.

Article 11. Data confidentiality requirements for drug registration files

Drug registrants who require data confidentiality for their drug registration files shall comply with the provisions of Circular 05/2010/TT-BYT and must clearly state their request in the application 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 file in specific cases as follows:

a) For Certificates of Pharmaceutical Product (CPP):

- CPPs showing signs of erasure or alteration of information;

- CPPs in the drug registration files of production establishments and registrants 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 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 and extension applications;

- CPPs of drugs produced by a first-time registering establishment in Vietnam, except where multiple establishments participate in production and at least one has already obtained a registration certificate for circulation in Vietnam;

- Electronic CPPs provided through self-searching from the electronic information website or English-language database of the issuing authority or competent authority of other countries, which cannot be verified online via the link provided in the file;

- CPPs 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 registrant and production establishment: Verification of authenticity applies to the legal documents of first-time registering and producing establishments in Vietnam.

2. For drugs already registered for circulation, the Drug Administration shall verify the authenticity of legal documents upon receiving written or email notifications, or public media information reflecting issues regarding licensing and circulation status in the home country requiring clarification, or information about non-compliance with operating conditions of foreign production and registration establishments.

3. Verification of the authenticity of CPPs and legal documents submitted in the drug registration file shall be conducted through written or official email correspondence as follows:

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 abroad 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 of 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 specified in item 1, 4, 5, 6 of point a of 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 of the drug registration file within the time limit set forth in Clause 5 of Article 56 of the Medicine Law. A drug will only be considered for issuance of a registration certificate if the verification results meet the requirements of the competent authorities mentioned in Clause 3 of this Article.

The request for verification of legal documents shall be sent simultaneously to the drug registrant. If the Drug Administration does not receive the verification result from the competent authority within six months of initiating the verification process, the Drug Administration shall report to the Council on the status of legal document verification and propose not to issue a registration certificate.

Chapter II

REQUIREMENTS FOR CLINICAL DATA TO ENSURE SAFETY, EFFECTIVENESS AND CRITERIA FOR DETERMINING CASES OF EXEMPTION FROM TRIAL, EXEMPTION FROM SOME STAGES OF CLINICAL TRIALS, DRUGS REQUIRED TO UNDERGO CLINICAL TRIAL STAGE 4 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;

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.

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.

- 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 for 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 producing and circulating medicines, vaccines, biological products;

g) Information displayed on the Certificate of Conformity (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 regarding 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 power of attorney.

In case of multiple drugs, the power of attorney letter must have 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 by consular authentication 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; dosage form;

- Content of the power of attorney;

- Validity of the power of attorney letter.

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

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

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

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

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

- In case 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 submitted with one power of attorney letter for signing on the registration dossier.

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

8. Permit to establish a Representative Office in Vietnam.

In case the name and address of the registering entity on the permit to establish a Representative Office in Vietnam differ from those 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: production, wholesale, export, import of drugs, raw materials for drugs (for foreign registering entities).

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

In case countries do not issue permits for production, wholesale, export, import of drugs, raw materials for drugs, they must provide a business establishment or registration certificate with a scope of business being at least one of the following forms: production, wholesale, export, import of drugs, raw materials for drugs, along with a certificate from the competent authority certifying that the entity meets the conditions and is currently 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 case the host country does not issue pharmaceutical business permits for raw material trading entities, accept permits according to the regulations of the host country which specify that the business scope of the entity includes one of the following: production, wholesale, export, import of raw materials for drugs.

10. In case 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, it is not necessary 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 production of herbal medicines) comply with Good Manufacturing Practices (GMP) can be one of the following types of documents:

a) GMP certificate;

b) Production permit with confirmation that the manufacturing facility complies with GMP;

c) CPP for active ingredients containing GMP compliance content;

d) Certificate of suitability of European Pharmacopoeia Monographs (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 (revised and supplemented at 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 the principles and standards of GMP that the excipient production facility complies with, and commit to 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 must provide a certificate of 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 complies with GMP, 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 circulated 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 entity (accepting color printouts matching the labels currently circulating in the home country). In cases where the actual user guide in the home country is not in English, a translation into English or Vietnamese with the confirmation stamp of the representative office or the registration entity or the production entity 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 as stipulated by the Minister of Health, and meet 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 entity.

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 compliant with GMP on the website of the Drug Administration of Vietnam, there is no requirement 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; in case of submitting copies, they must bear the confirmation stamp of the registration entity (accepting the stamp of the representative office for imported drugs).

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

The test report must include the following information: administrative information (name, 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 schedule of the Ministry of Health or those notified by the Drug Administration of Vietnam 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) or a drug testing service business entity 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 certificate.

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

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

a) Application form according to Model 5/TT issued together with this Circular;

b) Power of attorney bearing the name of 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) Business operation permit for the Vietnamese registering entity;

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 Model 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) Test report from the testing facility as stipulated in Clause 16, Article 22 of this Circular;

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

l) Sample labels and actual drug usage instructions circulating in the country of manufacture or the country granting the Certificate of Pharmaceutical Product (CPP) 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 when 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 registration certificate for generic drugs, herbal medicines, and drug ingredients as specified 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 registration certificate for explosive drugs, vaccines, biological products, herbal medicines, and drug ingredients as specified in points a, c, đ, e, m, n of Clause 1 of this Article and the following documents:

a) Power of attorney bearing the name of the registering entity for cases where the registering entity changes at the time of submitting the extension application;

b) Circulation report of drugs and drug ingredients according to Model 8/TT issued together with this Circular;

c) Copy of the drug registration certificate in Vietnam;

d) Monitoring and evaluation report on safety and efficacy; drug usage situation according to Model 2/TT issued together with this Circular for applications to extend the registration of chemical drugs, vaccines, biological products, and herbal medicines that require monitoring and evaluation reports on safety and efficacy as stipulated in Clause 2 of Article 5 of this Circular;

đ) Certificate of permission to produce or circulate drug ingredients in the country of manufacture for applications to extend the registration of foreign-produced drug ingredients;

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

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

Section 2. APPLICATION FILES FOR ISSUANCE, EXTENSION, CHANGE, AND SUPPLEMENTATION OF REGISTRATION LICENSES FOR CHEMICAL DRUGS, VACCINES, AND BIOPRODUCTS

Article 24. Quality Documents in Application Files for Issuance, Change, and Supplement of Registration Licenses for Chemical Drugs, Vaccines, and Bioproducts

Quality documents shall be prepared in accordance with Part II - ASEAN Common Technical Document (ACTD) or Module 3-ICH Common Technical Document (CTD) and the following provisions:

1. For vaccines and sera containing antibodies, blood derivatives:

a) A certificate of batch release issued by the competent authority of the exporting country or one of the regulatory authorities 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 Biologicals.

2. For rare drugs, drugs to meet defense and security needs; to prevent, control epidemics, diseases, mitigate the consequences of natural disasters, and special treatment needs:

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

b) Drugs to meet defense and security needs; to prevent, control epidemics, diseases, mitigate the consequences of natural disasters, and disasters:

Acceptable stability data at the time of application filing will be considered for determining the shelf life based on the Council's opinion in cases where the study period does not meet the minimum research time stipulated by ASEAN guidelines.

After obtaining the registration license, the entity must continue to submit finished product stability study files until the actual research period meets the minimum stability study period according to ASEAN guidelines through changes or supplements as stipulated in Appendix II of this Circular to review and update the shelf life as required.

In cases where the drug fails to meet the stability study results outlined in the registration file, the entity must immediately report to the Drug Administration Bureau for the Council to consider the drug's shelf life.

Based on the Council's advisory opinion, the Drug Administration Bureau will review and decide on the shelf life of the drug, including batches already produced, based on actual stability study data.

c) Special treatment drugs: available stability data 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 Region IVb climate conditions.

3. In cases where the manufacturing entity uses raw materials that have been granted a registration license 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 file;

b) The registering entity must submit:

- One test report for raw material drugs conducted by the finished drug manufacturer, which must include all quality criteria at equivalent or stricter levels 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 testing service provider that has obtained a business license;

- One test report for raw material drugs conducted by the raw material manufacturer.

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

a) Drug substance section:

- Name of drug substance (listed according to the International Nonproprietary Name);

- Name and address of the drug substance and intermediate manufacturers;

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

- One test report for drug substances and intermediates from the drug substance manufacturer and one test report for drug substances and intermediates from the finished drug manufacturer;

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

b) Finished product section:

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

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

- Finished product production, 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 study report.

c) Remaining quality file documents shall be prepared in accordance with Part II - ACTD or Module 3-ICH CTD and kept by the registering entity and the manufacturer.

5. Documents stipulated in this Article must comply with the following provisions:

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

- ASEAN Common Technical Document (ACTD);

- Stability study guidance;

- Production process evaluation guidance;

- Analytical method validation guidance;

- Bioavailability and bioequivalence study guidance;

b) For drug applications prepared according to ICH-CTD format and corresponding technical guidance, there is no requirement to convert the application according to point a of this clause;

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

- Certificate of Suitability (CEP) for drug substances along with all appendices issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

- Data from the analysis of batches of drug substances;

- If the retest period for the quality of the drug substance is not specified in the Certificate of Suitability (CEP), submit data on the stability study of the drug substance.

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

Preclinical documentation shall be carried out in accordance with the guidance provided in Part III-ACTD or Module 4-ICH-CTD.

For probiotic biologics originating from strains of bacteria with similar sources, concentrations, contents, indications, and dosages to those already approved by one of the regulatory authorities specified in Clause 9, Article 2 of this Circular, preclinical documentation need not be submitted.

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

Clinical documentation shall be carried out in accordance with the guidance provided in Part IV-ACTD or Module 5-ICH-CTD.

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

1. Application documents for issuing a new registration certificate for chemical drugs, vaccines, and biologics include:

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

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

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

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

e) In cases where the applicant requests classification of the original drug substance or reference biologic when submitting an application for issuance of a registration certificate for the drug, 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. Application documents for issuing a registration certificate for generic drugs include:

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

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

3. Application documents for extending a drug registration certificate include:

a) Administrative documents as prescribed in Clause 3, Article 23 of this Circular;

b) Relevant documents as prescribed in Appendix II issued together with this Circular for cases involving changes to administrative files (excluding changes to the drug label and drug usage instructions).

In cases where the applicant has submitted changes to the administrative file prior to the submission of the extension application but such changes have not yet been approved, there is no need to resubmit these documents in the extension application.

4. Application documents for amending or supplementing a drug registration certificate include:

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

b) Corresponding documents related to major and minor changes as prescribed in Appendix II issued together with this Circular. For vaccines produced by the same manufacturer or owner of the drug marketing authorization that accepts changes in the production site within the same country or outside the country where the marketing authorization was granted.

5. Application documents for issuing a drug registration certificate through a streamlined review process include:

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

b) Quality documentation carried out in accordance with the provisions of points a and b of Clause 4 of Article 24 of this Circular.

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

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

1. Raw Materials

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

b) Quality Standards and Testing Methods

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

- For semi-finished herbal products, similar quality standards and testing methods applicable to non-semi-finished herbal products as stipulated in Circular No. 38/2021/TT-BYT shall be applied.

c) Raw Material Test Report

- One test report of herbal drugs from the finished drug manufacturer. In case 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 providers that have obtained business licenses for drug testing services;

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

2. Finished Products

a) Production Process

- Formula for the smallest packaging unit: name, quantity, concentration, weight, and applicable standard of each component in the formula for one smallest packaging unit. In case the production is from semi-finished herbal products or herbal extracts, the corresponding amount of herbal raw material equivalent to semi-finished herbal products or herbal extracts or the ratio of herbal extracts to semi-finished herbal products relative to the initial herbal raw material or accompanied by the percentage content of active ingredients or quantified compound groups according to each herbal raw material must be clearly stated;

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

- Production process flow diagram: 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 production process: fully and detailedly describe each step in the production process including all technical parameters of each stage;

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

- Control during production: fully and detailedly describe the inspection 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

- 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 indicators, quality level, and testing methods;

đ) Stability Research Report following the stability research guidelines set forth in Appendix I attached to this Circular.

Article 29. Safety and efficacy documentation in the application dossier for registration, extension, change, and supplement of drug registration certificates 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. The documents specified in point b, Clause 1, Article 18 of this Circular (if applicable).

Article 30. Application dossier for registration, extension, change, and supplement of drug registration certificates for herbal medicines

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

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

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

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

2. The application dossier for extension of drug registration certificates for herbal medicines:

a) Administrative documents as prescribed in Clause 3, Article 23 of this Circular;

b) Relevant documents as prescribed in Section D of Appendix II issued together with this Circular for cases where there are administrative file changes at the time of extending the drug registration certificate (excluding changes in drug labels and drug usage instructions).

3. The application dossier for changing and supplementing drug registration certificates 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 prescribed in Section D of Appendix II issued together with this Circular.

Chapter 4. REGISTRATION DOCUMENTATION FOR DRUG RAW MATERIALS

Article 31. Quality Documentation in the Application Dossier for Registration, Change, and Supplement of Drug Raw Material Registration Certificates

1. For drug active ingredients: Follow the ACTD filing for active ingredients. In cases where the quality of the active ingredient is registered according to the manufacturer's standard, the overall active ingredient filing (Drug Master File) must be submitted.

2. For semi-finished raw materials containing active ingredients: Follow the ACTD filing as for finished drug products, wherein the finished product filing section is replaced by the semi-finished product filing; formulas for a single dose and smallest unit packaging are replaced by production batch formulas.

3. For semi-finished herbal medicine raw materials, excipients, and capsules:

a) Formulation for semi-finished herbal medicine raw materials, pre-mixed excipients, and capsules: components, weight, volume, quality standards of each component in the formula. In cases where raw materials originate from animals, 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 aligning 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 raw materials, apply similar provisions regarding quality standards and testing methods for non-semi-finished herbal medicine raw materials as stipulated in Circular No. 38/2021/TT-BYT;

- For excipients and capsules: 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, or 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:

a) Administrative documents as prescribed in Clause 3, Article 23 of this Circular;

b) Relevant documents as prescribed in Section B of Appendix II issued together with this Circular for cases where there are changes in administrative documents at the time of extending the circulation registration certificate (excluding changes in the raw material drug label design).

3. Documents for application to amend or supplement the drug raw material circulation registration certificate, including:

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

b) Corresponding documents for 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 DRUG AND DRUG RAW MATERIAL CIRCULATION REGISTRATION CERTIFICATES; SEQUENCE OF REVIEWING IMPORT DOCUMENTS FOR DRUGS WITHOUT A CIRCULATION REGISTRATION CERTIFICATE

Article 33. Cases to be processed through expedited review procedures or abbreviated review procedures

1. Cases to be processed through expedited review procedures

The drug registration dossier will be reviewed through an expedited procedure if it meets one of the following conditions:

a) Drugs listed in the Ministry of Health's Rare Drugs List;

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

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

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

đ) Specialized therapeutic drugs, drugs with special dosage forms, where there are no more than two (two) similar drugs (same active ingredient, same dosage form, same strength) with valid drug 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 under contract 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 meet 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 under contract 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 processed through abbreviated review procedures

The drug registration dossier will be reviewed through an abbreviated procedure if it meets 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 List;

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

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

2. Drug Administration:

a) Issue, extend, approve changes, and supplements to drug registration certificates, announce original brand names, reference medicinal products, and biological equivalent study reports on drugs, based on the advisory opinions of 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 b of this clause;

b) Announce on the Drug Administration Department's electronic information website the contents of changes and supplements to drug registration certificates and raw material registration certificates that only require notification (Notification).

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

1. Applications may be submitted online, directly, or via postal service to the Drug Administration Department.

2. After receiving complete applications, the Drug Administration Department shall issue an Application Receipt Form No. 9/TT to the applicant according to the Circular accompanying this Decision.

The Drug Administration Department shall accept applications without requiring the submission of CPP in cases stipulated in point e, Clause 4, Article 22 of this Circular and documents specified in point b, Clause 1, Article 24 of this Circular at the time of application submission.

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

4. Organizing the appraisal of applications for issuing, extending, changing, and supplementing drug registration certificates and raw material registration certificates, and applications for importing drugs without a registration certificate:

a) The Drug Administration Department shall transfer applications to experts or units assigned tasks by the Ministry of Health for organization of appraisal based on the list of experts established and approved by the Drug Administration Department or the appraisal units;

b) Based on the consolidated opinions of the experts or appraisal units and consideration of related information, the Drug Administration Department shall be responsible for proposing issuance, extension, change, and supplementation or non-issuance, extension, change, and supplementation of drug registration certificates and raw material registration certificates; issuance, non-issuance, or non-granting of import permits for drugs without a registration certificate. The proposal opinion of the Drug Administration Department shall be reflected in the appraisal minutes;

c) The Drug Administration Department shall submit the proposals of the Drug Administration Department as stipulated in point b of this clause to the Council for examination and advisory opinions in the following cases:

- Issuing, not issuing; extending, not extending; approving, not approving changes and supplements to drug registration certificates and raw material registration certificates, except in cases provided for in Clause 5 of this Article;

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

- Issuing, not issuing import permits for drugs without a registration certificate;

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

5. For applications for issuing, extending, changing, and supplementing drug registration certificates and raw material registration certificates, the entity may only be allowed to modify and supplement up to three times. If the number of modifications and supplements exceeds the aforementioned limit and the modified and supplemented application still fails to meet requirements, the Drug Administration Department shall issue a notice disagreeing with issuance, extension of the registration certificate, and approval of the modification and supplement application. The submitted application will lose its 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;

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 and Raw Material for Drugs

1. Within three months from the date of receiving all necessary documents, the Drug Administration shall extend the drug registration certificate and raw material for drugs. In cases where extension is not granted or has not been granted, 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 receiving the documents, the Drug Administration shall review, classify, and send the documents to the experts or units for assessment. Within one month from the date of receiving the documents from the Drug Administration, the experts or units for assessment must complete the assessment report and submit it to the Drug Administration 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 Drug Administration shall issue a written response for the assessment documents that have not met the requirements and state the reasons. For documents proposed for extension, non-extension, or requiring the opinion of the Council, the Drug Administration shall transfer them to the Council Office to organize a Council meeting;

c) Within six working days from the date of receiving the documents from the Drug Administration, the Council Office shall organize a Council meeting and send the Council meeting minutes back to the Drug Administration;

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

2. Within twelve months from the date the Drug Administration issues a notification regarding additional documents, the registering entity must submit supplementary documents as required. After this period, if the registering entity does not submit supplementary documents, the submitted documents will lose their validity.

The registering entity is permitted to update in writing to the Drug Administration about the submitted documents and during the assessment period for cases updating information related to the safety and efficacy of drugs or legal documents of the registering entity, drug manufacturing entity, raw material for drugs compared to the submitted documents.

3. Within three months from the date of receiving all supplementary documents, the Drug Administration shall issue a decision to extend the drug registration certificate for documents that meet the requirements; the Drug Administration shall issue a written response according to the Council's conclusion for documents that have not met the requirements and state the reasons.

The procedure and timeframe for reviewing supplementary documents shall be carried out according to the provisions of Clause 1 of this Article.

Article 38. Procedure for Changing and Supplementing the Drug Registration Certificate and Raw Material for Drugs During the Validity Period of the Drug Registration Certificate and Raw Material for Drugs

1. Changing and supplementing the drug registration certificate and raw material for drugs, except in cases stipulated in Clause 2 of this Article

Within three months from the date of receiving all necessary documents, the Drug Administration shall approve the changes and supplements. In cases where approval is not granted or has not been granted, 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 receiving all necessary documents, the Drug Administration shall review, classify, and send the documents to the experts or units for assessment. Within one month from the date of receiving the documents from the Drug Administration, the experts and units for assessment must complete the assessment report and submit it to the Drug Administration 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 from the experts or units for assessment, the Drug Administration shall issue a written response for the assessment documents that have not met the requirements and state the reasons. For assessment documents that meet the requirements or other cases requiring the opinion of the Council, the Drug Administration shall transfer them to the Council Office to organize a Council meeting;

c) Within six working days from the date of receiving the documents from the Drug Administration, the Council Office shall organize a Council meeting and issue the Council meeting minutes to the Drug Administration;

d) Within eighteen working days from the date of receiving the Council meeting minutes, the Drug Administration shall publish the original brand name, reference biological product, biosimilar drug with bioequivalence study report, approve the changes and supplements, or issue a written response according to the Council's conclusion for assessment documents that have not met the requirements and state the reasons.

2. Changing and supplementing the drug registration certificate and raw material for drugs for minor changes only requiring notification (Notification):

Within fifteen working days from the date of receiving all necessary documents, the Drug Administration shall classify and publish minor changes only requiring notification on the Drug Administration's electronic information website. If the changes and supplements do not comply with the classification for minor changes only requiring notification, the Drug Administration shall issue a notification.

The entity is responsible for implementing and bearing full responsibility for the changes and supplements from the date recorded on the receipt of the documents. The drug registering entity and the drug manufacturing entity bear legal responsibility for the accuracy and truthfulness of the information for changes and supplements only requiring notification, and must retain relevant documents for post-market inspection by competent authorities.

3. Within thirty-six months for cases requiring preclinical and clinical data, bioequivalence data, stability research data, or within twelve months for other supplementary data, from the date the Drug Administration issues a notification, the registering entity must submit supplementary data as required. After this period, if the registering entity does not submit supplementary data, the submitted documents will lose their validity.

4. Within two months from the date of receiving complete supplementary documents for the dossier specified in Clause 1 of this Article, the Drug Administration shall approve changes and supplements to the registration certificate for dossiers meeting the requirements; provide a written response for dossiers that do not meet the requirements, specifying the reasons. The timeframes for each step are specifically as follows:

a) Within five working days from the date of receiving complete dossiers, the Drug Administration shall review, classify, and forward the dossiers to experts or units for assessment. Within eight working days from the date of receiving the dossiers from the Drug Administration, the experts or units for assessment must complete the assessment record 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 receiving the assessment records from the experts or units for assessment, the Drug Administration shall provide a written response for dossiers that do not meet the requirements, specifying the reasons. For dossiers that meet the requirements or other cases requiring the opinion of the Council, the Drug Administration shall transfer them to the Council's Office to organize a Council meeting;

d) Within eighteen working days from the date of receiving the Council meeting minutes, the Drug Administration shall announce the original brand name, reference biological product, and drug with a bioequivalence study report; approve the content of changes and supplements to the drug for dossiers meeting the requirements. The Drug Administration shall provide a written response according to the Council's conclusion for dossiers that do not meet the requirements, specifying the reasons.

5. The timeframe 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. In some cases of changes and supplements, the drug registration entity and the drug manufacturing entity are responsible for updating on the label and drug usage instructions without having to submit a dossier or notify the Drug Administration, including the following cases:

a) Implementing the labeling of drugs, drug ingredients, and drug usage instructions as stipulated in Clause 2 of Article 35 of Circular No. 01/2018/TT-BYT dated January 18, 2018, issued by the Minister of Health regarding drug labeling and drug ingredient labeling and the drug usage instruction sheet;

b) Implementing changes and supplements to the content of the label and drug usage instructions according to the Drug Administration's circular guiding the Council's policy;

c) Apart from the cases where samples of labels and drug usage instructions must be resubmitted upon changes and supplements as prescribed in Appendix II attached to this Circular, other changes related to information on the label and drug usage instructions, registration entity, and manufacturing entity must be self-updated once approved by the Drug Administration for these changes and supplements;

d) Other contents:

- Changing the position or information of the drug import entity or drug ingredient import entity on the label or drug usage instruction sheet;

- Correcting typographical errors on the label or drug usage instruction sheet;

- Changing the layout of sections in the drug usage instruction sheet without altering the content of the drug usage instruction sheet already approved according to the regulations for the drug usage instruction sheet;

- Supplementing quality standard information on the label and drug usage instruction sheet based on the dossier already approved by the Drug Administration;

- Removing non-mandatory information on the label and drug usage instruction sheet.

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

1. Within six months from the date of receiving all necessary documents, the Drug Administration Department shall issue a drug registration certificate for drugs and drug ingredients. In case of non-issuance or delay in issuance, the Drug Administration Department shall provide a written response specifying the 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 documents to experts or reviewing units. Within three months from the date of receiving the documents 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 for the non-compliant review documents and specify the reasons. For compliant review documents, those that do not meet requirements, or other cases requiring the opinion of the Drug Registration Certificate Issuing Advisory Board, the Drug Administration Department shall transfer the documents to the Board's Office to convene a meeting of the Board;

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

3. Within three months from the date of receiving supplementary materials, the Drug Administration Department shall issue a decision on the issuance of a drug registration certificate for compliant documents; the Drug Administration Department shall provide a written response based on the Board's conclusion for non-compliant review documents and specify the reasons. The timeframes for each step are specified as follows:

a) Within ten working days from the date of receiving the documents, the Drug Administration Department shall conduct a review, classification, and forward the documents to the reviewing experts or units. Within sixteen working days from the date of receiving the documents 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 recommendation 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 for non-compliant review documents and specify the reasons. For documents recommended for issuance, non-issuance, or requiring further consultation from the Board, the Drug Administration Department shall transfer them to the Board's Office to convene a meeting of the Board;

Chapter V

REVOCATION OF DRUG REGISTRATION CERTIFICATE, SUSPENSION OF APPLICATION FOR ISSUANCE, EXTENSION OF DRUG REGISTRATION CERTIFICATE

Article 40. Authority and procedures for revoking a drug registration certificate

1. Authority to revoke and responsibility to notify the revocation of a drug registration certificate:

a) The Drug Administration Department shall revoke the drug registration certificate for drugs and drug ingredients in cases stipulated in Clause 1, Article 58 of the Medicine Law;

b) Provincial Health Departments under the Central Government and Health Departments of various sectors shall notify the decision of the Drug Administration Department regarding the revocation of the drug registration certificate for drugs and drug ingredients within their jurisdiction;

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

Within thirty days from the date of the competent authority's decision to revoke the drug, the Drug Administration Department shall issue a decision to revoke the drug registration certificate for drugs and drug ingredients;

3. Procedures for revoking a drug registration certificate for drugs and drug ingredients as stipulated in points d and đ of Clause 1, Article 58 of the Medicine Law:

Within thirty days from the date of the competent authority's written conclusion that the application for a drug registration certificate is fraudulent or that the drug or drug ingredient was produced at a location different from that stated in the application, the Drug Administration Department shall issue a decision to revoke the drug registration certificate for drugs and drug ingredients;

4. Procedures for revoking a drug registration certificate for drugs and drug ingredients 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 upon receipt of a notification from WHO or the country of origin recommending that the drug is unsafe or ineffective for users or that the foreign competent authority has revoked the product certification, the Drug Administration Department shall issue a decision to revoke the drug registration certificate for drugs and drug ingredients;

5. Procedures for revoking a drug registration certificate for drugs and drug ingredients as stipulated in point g of Clause 1, Article 58 of the Medicine Law:

a) The entity shall submit a request for revocation of the drug registration certificate for drugs and drug ingredients in Vietnam by the manufacturing entity or the registering entity using Form 1/TT issued together with this Circular;

b) Within twenty days from the date of receiving the request for revocation, the Drug Administration Department shall issue a decision to revoke the drug registration certificate for drugs and drug ingredients.

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

1. The 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 Medicine 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 ISSUANCE OF DRUG REGISTRATION CERTIFICATES, RAW MATERIALS FOR DRUGS, 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 Issuance of Drug Registration Certificates. Members of the Board shall be experts with appropriate professional qualifications and experience to ensure the ability to review applications, provide critical feedback on the opinions of reviewing experts, proposals from the Department of Medicine Management, and advise the Minister of Health on issues related to pharmaceutical regulations, quality, safety, and efficacy of drugs and raw materials for drugs.

2. The Board shall be responsible for advising the Minister of Health on issuing, extending, changing, and supplementing drug registration certificates; granting import permits for drugs not yet registered in Vietnam based on the results of reviews by experts, proposals from the Department of Medicine Management, and other issues requested by the Minister of Health. The Board shall be accountable 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 based on legal grounds, scientific foundations, consideration of the results of application reviews by reviewing experts, practical clinical evidence, and proposals from the Department of Medicine Management;

b) The Board shall convene when at least two-thirds of its members who meet the conditions (as stipulated in the Organizational and Operational Regulations of the Board issued by the Ministry of Health) attend. In cases where members cannot attend but submit their opinions in writing, 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 with the conclusion of the Board.

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 submitting opinions has passed, the Chairman of the Board or a person authorized to do so shall draw 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 conclusion of the Board 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 from the Department of Medicine Management;

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

d) When necessary, Board members may examine and review applications, and the Chairman of the Board may seek additional opinions from independent experts outside the Board before drawing a final conclusion. These experts may directly participate in the Board meeting or provide opinions in writing, bearing responsibilities and rights similar to those of regular Board members;

e) Not to violate principles concerning conflicts of interest.

4. The Department of Medicine Management shall advise the Minister of Health to issue regulations on the organization and operation of the Board, mechanisms for coordination between the Board and reviewing experts during the process of issuing, extending, changing, and supplementing drug registration certificates, and import permits for drugs not yet registered in Vietnam.

5. Operating expenses of the Board shall be carried out in accordance with the provisions of the law.

6. The Standing Committee of the Board shall be located at the Department of Medicine Management.

Article 43. Organization and activities of units for reviewing applications for issuing, extending, changing, supplementing drug registration certificates and raw materials for drugs, and reviewing applications for importing drugs without a registration certificate.

1. The Drug Administration of Vietnam, the reviewing unit, shall establish specialized review subcommittees: legal affairs; quality standards; pharmacology; clinical trials; formulation and stability; bioequivalence, and lists of experts in these subcommittees for reviewing applications for issuing, extending, changing, supplementing drug registration certificates and raw materials for drugs, and reviewing applications for importing drugs without a registration certificate. The structure of the specialized review subcommittees must be appropriate to the classification of registered products and registration forms or products proposed for importation permits and proposed importation permit forms.

2. Review experts shall operate according to the principle that review opinions must ensure legal grounds, scientific bases, and must be reflected in the minutes of the review of applications for issuing, extending, changing, supplementing drug registration certificates and raw materials for drugs, or the minutes of the review of applications for importation permits for drugs without a registration certificate. Review experts are responsible before the Director of the Drug Administration of Vietnam and before the reviewing unit for the contents of the review, recommendations related to the review of applications for issuing, extending, changing, supplementing drug registration certificates and raw materials for drugs, and the review of importation applications for drugs without a registration certificate.

3. The Drug Administration of Vietnam, based on its assigned functions and tasks, shall develop and promulgate regulations on the organization and operation of review expert groups (including experts from the reviewing unit) for applications for issuing, extending, changing, supplementing drug registration certificates and raw materials for drugs, and importation applications for drugs without a registration certificate; sign contracts with review experts or reviewing units.

The Drug Administration of Vietnam and the reviewing unit shall organize training courses and training for review experts; conduct evaluations of the professional capabilities of review experts established by the unit and compliance with regulations to adjust and supplement review experts appropriately.

4. The budget for organizing the review of applications shall be implemented in accordance with the provisions of the law.

Chapter VII

IMPLEMENTING PROVISIONS

Article 44. Effective date of implementation

1. This Circular takes effect from October 20, 2022.

2. The following regulations are abolished:

a) Circular No. 32/2018/TT-BYT dated November 12, 2018, issued by the Minister of Health, stipulating drug registration procedures;

b) Clause 3, Article 1 of Circular No. 23/2021/TT-BYT dated December 9, 2021, issued by the Minister of Health, amending and supplementing certain legal normative documents issued by the Minister of Health;

c) Clause 5, Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020, issued by the Minister of Health, amending and supplementing and abolishing certain legal normative documents issued by the Minister of Health, jointly issued;

d) Point h, Clause 3, Article 14 of Circular No. 01/2018/TT-BYT dated January 18, 2018, issued by the Minister of Health, stipulating labeling of drugs and raw materials for drugs and instructions for drug use.

Article 45. Transitional Provisions

1. Applications submitted before the date this Circular takes effect shall continue to be processed according to the regulations at the time of submission, except where the registering entity voluntarily implements the regulations from the date of issuance of this Circular.

2. Applications submitted to the receiving authority before the date this Circular takes effect but still under processing shall be applied according to relevant provisions of this Circular or previous regulations up to the date this Circular takes effect, in a manner convenient for enterprises, organizations, and individuals.

3. Drugs submitted for registration according to regulations prior to the effective date of Circular No. 32/2018/TT-BYT and granted a registration certificate or extended registration certificate may only be produced from raw materials manufactured by production facilities meeting good manufacturing practices within the scope specified in Article 141 of Decree No. 54/2017/NĐ-CP. Production facilities and registering entities must retain documentation proving compliance as stipulated in Clause 11, Article 22 of this Circular and present it to relevant authorities upon request.

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 công 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

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.

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.

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./.

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75/2017/NĐ-CP Nghị định số 75/2017/NĐ-CP Quy định chức năng, nhiệm vụ, quyền hạn và cơ cấu tổ chức của Bộ Y tế Còn hiệu lực 54/2017/NĐ-CP Nghị định số 54/2017/NĐ-CP Quy định chi tiết một số điều và biện pháp thi hành Luật dược Hết hiệu lực 155/2018/NĐ-CP Nghị định số 155/2018/NĐ-CP 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 Còn hiệu lực 105/2016/QH13 Luật Dược số 105/2016/QH13 Còn hiệu lực

Bị sửa đổi, bổ sung bởi 1

55/2024/TT-BYT Thông tư số Thông tư 55/2024/TT-BYT sửa đổi gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư 08/2022/TT-BYT quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc do Bộ trưởng Bộ Y tế ban hành Hết hiệu lực

Bị thay thế bởi 1

12/2025/TT-BYT Thông tư số 12/2025/TT-BYT Quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc Còn hiệu lực

Được dẫn chiếu bởi 1

45/2024/TT-BYT Thông tư số Thông tư 45/2024/TT-BYT sửa đổi Thông tư 11/2018/TT-BYT quy định về chất lượng thuốc, nguyên liệu làm thuốc do Bộ trưởng Bộ Y tế ban hành07/02/2025 Hết hiệu lực

08/2022/TT-BYT

Circular No. 08/2022/TT-BYT stipulates the registration for circulation of drugs and drug raw materials

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Tiếng Việt Thông tư số 08/2022/TT-BYT quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc 한국어 시설 제 8 호 2022년 보건 병원부 통일 규칙은 약물 및 약제 원료의 유통 등록에 관한 사항을 규정함 中文通函2022年第8号规定药品和药用原料的流通登记事项

Circular No. 08/2022/TT-BYT stipulates the registration for circulation of drugs and drug raw materials

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