Circular No. 32/2018/TT-BYT provides detailed regulations on the application for issuance, extension, modification, and supplementation of registration certificates for chemical drugs, vaccines, and biological products.

CIRCULAR

PROVISIONS ON THE REGISTRATION OF DRUGS AND DRUG SUBSTANCES FOR CIRCULATION

Pursuant to the Drug Law dated April 6, 2016;

Pursuant to DecreeNo. 54/201Decree No. 7/2017/NĐ-CP dated May 8, 2017 of the Government detailing the implementation of the Drug Law;No. ment detailing some provisions and measuresinternational pursuant to the Medicine Law;

Pursuant to DecreeNo. 75/201Decree No. 7/2017/NĐ-CP dated June 20, 2017 of the Government;"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation.""4. As of March 31, 2021, credit card issuers that issue cards with BINs issued by the State Bank of Vietnam must comply with the Domestic Chip Card Standard."onThe Director of the Office, Heads of Payment Department, Heads of units under the State Bank of Vietnam; credit institutions, foreign bank branches, payment switching organizations, electronic transaction settlement organizations are responsible for implementing this Circular.of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home AffairsFor traditional medicine doctors, traditional medicine practitioners, licensed traditional medicine practitioners, and those with hereditary prescriptions or hereditary treatment methods, the scope of professional activities shall be implemented according to another Circular issued by the Minister of Health.

Pursuant to DecreeNo. 155/201Decree No. 8/2017/NĐ-CP dated November 12, 2016 of the Government amending and supplementing certain provisions related to investment conditions for business activities under the management of the Ministry of Health;June 2024;Decision 11/2018 of the Government amending and supplementing part thereof;No. Decree No. 8/2017/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment conditions for business activities under the management of the Ministry of Health;internationalpharmaceutical business under the State management of the Ministry of Health;

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

The Minister of Health issues this Circular to provide detailed regulations on the registration of drugs 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) Clinical data requirements to ensure safety and efficacy in drug registration documents;

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

d) Principles governing the organization and operation of experts reviewing applications for issuing, extending, changing, and supplementing certificates for the circulation of drugs and drug substances;

đ) Principles governing the organization and operation of experts reviewing applications for importing drugs without certificates for circulation as specified in point a, Clause 43, Article 5 of Decree No. 155/2018/NĐ-CP;

e) Principles governing the organization and operation of advisory boards for issuing certificates for the circulation of drugs and drug substances;

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

2. This Circular does not apply to cases specified in Clause 2, Article 54 of the Drug Law regarding drug substances that do not need to be registered before circulation in Vietnam, semi-finished traditional medicine products produced by the manufacturing facility for finished traditional medicine products.

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 documents 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 document model of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

3. Major Change refers to changes with significant and direct impacts on the quality, safety, and efficacy of drugs, as defined in Appendix II attached hereto.

4. Minor Change refers to changes with no impact or minimal impact on the efficacy, quality, and safety of drugs, as defined in Appendix II attached hereto.

5. Drug Registration Applicant, Drug Substance Registration Applicantintention drugs, raw materials lfor drug production is the entity named in the application for issuing, extending, changing, or supplementing certificates for the circulation of drugs 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 performing the release of a batch of drug substances.

8. Product License Holder or Product Owner in relation to foreign drugsNo.compared to foreign drugs is the legally responsible entity for the product and recorded on the Drug Product Certificate (CPP).

9. Reference Regulatory Authorityintention as defined in this Circular includes: the European Medicines Agency (EMA), the United States, Japan, France, Germany, Sweden, the United Kingdom, Switzerland, Australia, Canada, Belgium, Austria, Ireland, Denmark, and the Netherlands. Strict Regulatory Authority (SRA - Stringent Regulatory Authorities)

10. Reference Regulatory Authorityintention are regulatory authorities classified by the World Health Organization (WHO) in the SRA list, including: a) Pre-October 23, 2015 ICH members, including: the US Food and Drug Administration (US-FDA), the European Commission's Medicines Agency, the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the Japanese Pharmaceutical and Medical Devices Agency (PMDA);

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

c) Members with agreements recognizing each other with pre-October 23, 2015 ICH members including: Australia, Ireland, Liechtenstein, and Norway.

c) Members having an agreement on mutual recognition with ICH Member before October 23, 2015 including: Australia, New Zealand, Liechtenstein and Norway.

11. Drug Product Certificate (CPP) is a certificate issued under the WHO Quality Certification System for circulating pharmaceutical products in international trade.

12. Semi-finished Traditional Medicine Product is raw material for producing traditional medicine-based drugs in the form of extracts, powders, granules, decoctions, essential oils, resins, gums, and jellies.

Article 3. Responsibilities towards the drug registration facility, raw material for drugs

1. Shall be responsible for changing and supplementing the content of the label and instructions for drug use according to the content in the update request document issued by the Ministry of Health (the Drug Administration Department) during the validity period of the drug circulation registration certificate without having to submit a change or supplementary registration application.

2. Shall implement changes and supplements in accordance with Clause 4, Article 28 and Article 40 promulgated together with this Circular during the validity period of the drug circulation registration certificate and raw material for drugs.

3. Ensure the quality, safety, and efficacy of drugs and raw materials for drugs in accordance with the registration dossier.

4. Shall be responsible for the legality and accuracy of all documents in the registration dossier. Coordinate with the drug manufacturing facility and foreign competent authorities in responding to Drug Administration Department documents requesting verification of the authenticity of relevant legal documents in the drug registration dossier.

5. Shall notify the Drug Administration Department in writing within thirty days from the date of the decision to revoke the drug circulation registration certificate at any country worldwide for drugs and raw materials for drugs that have been granted a circulation registration certificate in Vietnam still in effect, and specify the reasons for revocation.

6. Shall closely coordinate with the drug manufacturing facility to ensure that at least one of these two facilities conducts research or provides additional information related to the registered drug when there is information or evidence related to the safety and efficacy of the drug during circulation as required by the competent state management authority.

7. Shall coordinate with the drug manufacturing, importing, and distributing facilities to carry out monitoring, collecting, compiling, evaluating, and reporting adverse drug reactions and post-vaccination reactions to the National Center for Drug Information and Adverse Drug Reaction Monitoring (National DI & ADR Center) in accordance with Clause 5, Article 77 of the Medicine Law, Good Pharmacovigilance Practices guidelines, national pharmacovigilance guidelines, and related regulations.

8. Shall ensure the maintenance of operational conditions of the registration facility during the validity period of the drug circulation registration certificate and raw materials for drugs. In case of non-compliance with operational conditions, the registration facility shall be responsible for implementing a change in the registration facility in accordance with Clause 4, Article 28 and Article 40 of this Circular within thirty days from the date the registration facility no longer meets operational conditions.

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

10. Shall cooperate with the manufacturing facility to update the quality standards of drugs and raw materials for drugs in accordance with Circular No. 11/2018/TT-BYT dated May 4, 2018, of the Minister of Health on drug quality and raw materials for drugs (hereinafter referred to as Circular No. 11/2018/TT-BYT) and Circular No. 13/2018/TT-BYT dated May 15, 2018, of the Minister of Health on herbal medicine and traditional drug quality.

11. Shall implement the risk management plan approved in the application for issuance and extension of the drug circulation registration certificate for vaccines.

12. Shall be responsible in accordance with Clause 2, Article 57 of the Medicine Law and the provisions of this Article for drugs and raw materials for drugs registered by the registration facility from the date the Drug Administration Department issues a letter approving the change of the registration facility, including drugs and raw materials for drugs already in circulation before the Drug Administration Department issues a letter approving the change of the registration facility, in accordance with current laws.

13. Shall bear other responsibilities as prescribed in this Circular and other relevant laws.

Article 4. Responsibilities towards pharmaceutical production facilities and raw material manufacturing facilities

1. Must produce pharmaceuticals and raw materials for pharmaceuticals at the correct facility with a production permit issued by the competent state authority.

2. Propose to revoke the registration certificate for circulation in cases where pharmaceuticals and raw materials for pharmaceuticals have quality, safety, and efficacy issues affecting the health of users according to Model 1/TT attached to this Circular.

3. Coordinate with the registration facility for pharmaceuticals and raw materials for pharmaceuticals to implement the provisions of Clause 1, 2, and 3 of Article 3 of this Circular.

4. Coordinate with the registration facility for pharmaceuticals to fulfill requirements for inspection and evaluation of the production facility when requested by the competent management authority.

5. Ensure the operating conditions of the production facility within the validity period of the registration certificate for pharmaceuticals and raw materials for pharmaceuticals.

6. Implement changes to the registration facility for pharmaceuticals and raw materials for pharmaceuticals that have been granted a registration certificate for circulation within thirty days from the date the Drug Administration Department signs a notification letter regarding the registration facility no longer meeting operational conditions.

7. Update the quality standards for pharmaceuticals and raw materials for pharmaceuticals in accordance with Circular No. 11/2018/TT-BYT.

Article 5. Provisions on monitoring, evaluating safety and efficacy reporting

1. Pharmaceutical business establishments and medical examination and treatment facilities must monitor, supervise, collect, compile, evaluate, and report to the competent state management authority information on post-vaccination reactions and adverse drug reactions in accordance with Article 77, Article 78 of the Medicine Law, Good Pharmacovigilance Practices guidelines, national pharmacovigilance guidelines, and related regulations.

2. The registration facility for pharmaceuticals must report safety and efficacy evaluations for pharmaceuticals specified in Clause 2 of Article 8 of this Circular according to Model 2A/TT (for pharmaceuticals) or Model 2B/TT (for vaccines):

a) Annually within the validity period of the registration certificate, submit to the National Center for DI &ADR for compilation, evaluation, and reporting to the Drug Administration Department;

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

3. Medical examination and treatment facilities using pharmaceuticals must report the situation of pharmaceutical usage according to Model 2C/TT (for pharmaceuticals) issued together with this Circular annually within the validity period of the registration certificate for pharmaceuticals specified in Clause 2 of Article 8 of this Circular and submit to the National Center for DI &ADR for compilation, evaluation, and reporting to the Drug Administration Department.

Article 6. Language, form of application, number of applications, and documents

1. Language used in the registration dossier

The registration dossier for pharmaceuticals and raw materials for pharmaceuticals must be written in Vietnamese or English. The drug user guide and product summary must be written in Vietnamese.

2. The registration dossier for pharmaceuticals and raw materials for pharmaceuticals must be prepared on A4 paper size, securely bound (except for online submissions). The dossier must include a cover page (Model 3/TT), a product information sheet (Model 4/TT) arranged in the correct order according to the table of contents (Model 5/TT), with clear separation between sections. Each section must be numbered for easy reference and must bear the stamp of the registration facility or the pharmaceutical production facility at the first page of each section throughout the entire dossier (accepting the stamp of the representative office for foreign pharmaceuticals).

The following documents must be compiled separately and accompanied by one product information sheet:

a) Bioequivalence research documentation;

b) Preclinical and clinical documentation;

c) Documentation assessing compliance with GMP as stipulated in Articles 95 and 98 of Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government for foreign pharmaceutical production facilities and raw material manufacturing facilities when registering for circulation in Vietnam.

3. Pharmaceuticals (excluding vaccines) 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 per dose unit for solid dosage forms with dosing; identical concentration or content of active ingredient for solid dosage forms without dosing, liquids, or semi-solids; identical concentration or content of active ingredient and direct contact packaging material for injectable and infusion products.

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

a) One complete set of dossier as prescribed in Clause 1, 2, 3, 5, 6, 7 of Article 28 of this Circular for chemical drugs, vaccines, and biological products, and the dossier prescribed in Clause 1, 2 of Article 31, Clause 1, 2 of Article 33 of this Circular for herbal drugs and raw materials for pharmaceuticals;

b) One full copy of the dossier for vaccines; two copies of the application form, drug quality standards, and testing methods for other cases;

c) Two sets of sample drug labels and drug user guides intended for circulation, stamped by the registration facility (accepting the stamp of the representative office for foreign pharmaceuticals) or the production facility. The drug labels are affixed and designed on A4 paper.

5. Number of documents to be submitted in the application dossier for changing and supplementing the registration certificate:

a) One complete set of documents as prescribed in Clause 4 of Article 28 of this Circular for chemical drugs, vaccines, and biological products, and Clause 3 of Article 31, Clause 3 of Article 33 of this Circular for herbal drugs and raw materials for pharmaceuticals.

b) Two sets of sample drug labels and drug user guides proposed for change in case of label and user guide changes, stamped by the registration facility (accepting the stamp of the representative office for foreign pharmaceuticals) or the production facility. The drug labels are affixed and designed on A4 paper.

6. Provisions on the application of online dossiers:

a) Number of documents, composition of the dossier: 01 (one) complete set of documents in accordance with this Circular for online registration and an additional 01 paper copy of the administrative dossier (excluding labels and drug usage instructions) to be submitted to the Drug Administration.

b) The timeline for applying the online dossier as announced by the Minister of Health.

Article 7. Fees for registering drugs and drug ingredients

The entity registering drugs and drug ingredients must pay the relevant fees for drug registration in accordance with current laws on fees and charges.

Article 8. Validity and designation of the drug circulation registration certificate and the deadline for submitting the application for extending the validity period

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

2. The validity period of the circulation registration certificate is three 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, dosage form as new drugs that have not been issued a circulation registration certificate with a five-year validity period;

c) Drugs not falling under the cases specified in Points a and b of this Clause but at the time of submitting the application for extending the circulation registration certificate, there is no safety and efficacy report due to non-circulation or there is a safety and efficacy report but the quantity of drugs used, the number of patients, and the duration of use are limited according to the Advisory Council's opinion on drug circulation registration certificates or there is a recommendation from healthcare facilities to continue monitoring safety and efficacy;

d) Cases where safety and efficacy monitoring continues according to the Advisory Council's advice on drug circulation registration certificates.

3. Within twelve months before the circulation registration certificate expires, the registering entity may submit an application for extending the circulation registration certificate. After the circulation registration certificate has expired, the entity must submit the application in the form of issuing a new circulation registration certificate.

4. Each drug circulation registration certificate has a unique code to distinguish between domestically produced drugs, imported drugs, vaccines, biological products, technology-transferred drugs, and drugs repackaged in Vietnam.

5. During the validity period of the old circulation registration certificate, if the registering entity extends the new circulation registration certificate, the validity of the old circulation registration certificate will continue to be effective concurrently with the new circulation registration certificate for six months from the date the new circulation registration certificate becomes effective.

Article 9. Criteria for Proposing Generic Drugs Classification

1. Drugs proposed to be classified as generic drugs (not applicable to biological products) must be identified in the drug registration application and must meet the following criteria simultaneously:

a) Having complete clinical data on safety and efficacy as prescribed in Article 13 of this Circular;

b) Being approved for circulation by one of the management agencies specified in Clause 9, 10 of Article 2 of this Circular, except for newly produced drugs in Vietnam.

A generic drug before any change in the manufacturing facility or technology transfer in Vietnam as stipulated in Clause 2, 3 of this Article will still be recognized as a generic drug.

2. For drugs that have been announced as generic drugs by the Ministry of Health as stipulated in Clause 1 of this Article and subsequently transferred production technology for one, some, or all stages at a drug manufacturing facility in Vietnam, they must ensure that both the generic drug and the drug manufactured in Vietnam meet the following criteria simultaneously:

a) Same formulation process;

b) Same production process;

c) Same quality standards for raw materials;

d) Same quality standards for finished products;

đ) If there is any change related to the requirements in Points a, b, c, d of this Clause, the registering entity must provide data proving that the drug manufactured in Vietnam is equivalent in quality to the original generic drug before the transfer.

3. Drugs that have been announced as generic drugs and have changed their manufacturing facility, the new circulation registration certificate issued by the changed manufacturing facility will also be announced as a generic drug based on a written request from the registering entity if it meets the following criteria simultaneously:

a) The drug is approved for circulation by one of the management agencies specified in Clause 9, 10 of Article 2 of this Circular;

b) The drug meets the requirements specified in Point a, b, c, d of Clause 2 of this Article.

Article 10. Requirements for registering drugs produced in Vietnam under technology transfer form or secondary packaging

1. Drugs registered under technology transfer form must simultaneously meet the following requirements:

a) The technology transfer for drug production must be carried out in the form of transferring one, several, or all stages of the finished drug production process, excluding cases where only the secondary packaging stage is transferred;

b) The registered drug and the drug before technology transfer must simultaneously meet the following criteria:

- Same formulation;

- Same production process;

- Same quality standard for raw materials;

- Same quality standard for finished drugs;

If there is any change related to the above requirements, the registration entity must provide data proving that the drug produced in Vietnam is equivalent in quality to the drug before technology transfer.

c) Specifically, for generic systemic drugs, the drug before technology transfer must have been proven bioequivalent according to regulations, except in cases where the dosage form is exempted from bioavailability testing according to Circular No. 08/2010/TT-BYT dated April 26, 2010, issued by the Minister of Health guiding the reporting of bioavailability/bioequivalence study data in drug registration;

d) The dossier must comply with the provisions of Clause 5, Article 28 of this Circular.

2. Drugs implementing secondary packaging in Vietnam

a) Within five years from the date of issuance of the circulation permit, the registration entity and the production entity must complete the transfer of all production stages according to the conditions stipulated in Clause 1 of this Article. Three years from the date of issuance of the circulation permit, the registration entity must report on the progress of the technology transfer according to Form 6/TT issued together with this Circular;

b) The dossier must comply with the provisions of Clause 6, Article 28 of this Circular.

3. Drugs before technology transfer and secondary packaging may continue to circulate based on the validity period of the circulation permit already issued.

Article 11. Data confidentiality requirements for drug registration dossiers

Entities registering drugs that require data confidentiality for their registration dossiers shall implement according to the provisions of Circular No. 05/2010/TT-BYT dated March 1, 2010, issued by the Minister of Health guiding data confidentiality in drug registration, and must clearly state the request in the application form according to Form 6/TT issued together with this Circular.

Article 12. Provisions on verifying the authenticity of information on legal documents

1. The Drug Administration of Vietnam will coordinate with diplomatic agencies and relevant domestic and foreign agencies to verify the authenticity of legal documents in drug registration dossiers, specifically as follows:

a) CPP of all applications for issuing, extending, changing, or supplementing drug circulation permits;

b) Legal documents issued by competent foreign authorities for foreign entities registering drugs in Vietnam for the first time.

2. Verification will be conducted concurrently with the dossier examination procedure and within the timeframe specified in Clause 5, Article 56 of the Medicine Law.

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 MUST BE TRIED IN CLINICAL PHASE 4 IN VIETNAM

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

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

a) Clinical studies of the drug and clinical data in the 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, reference regulatory agency guidelines as stipulated in Clause 9, Article 2 of this Circular), except in cases provided for in Clause 2 of this Article;

b) Clinical data (excluding biosimilar biological products and vaccines similar to vaccines already registered 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, Clause 1 of this Article, or must have bridging study data according to ICH-E5 guidelines to extrapolate clinical data on the Asian population;

c) Vaccines that have been granted permission for circulation and comply with the provisions of Point g, Clause 4, Article 23 of this Circular and have complete clinical data on safety and efficacy as required in Points a and b, Clause 1 of this Article but have not yet been produced entirely on production lines in countries specified in Clause 10, Article 2 of this Circular must have clinical data related to the evaluation of safety and immunogenicity in the target population in Vietnam before being granted permission for circulation.

d) Vaccines that have complete clinical data evaluating safety and efficacy as required in Points a and b, Clause 1 of this Article but do not meet the requirements of Point g, Clause 4, Article 23 of this Circular must have clinical data related to the evaluation of safety and immunogenicity in the target population in Vietnam before being granted permission for circulation.

2. In cases where research was conducted prior to the issuance of regulations and guidelines for drug development research as specified in Point a, Clause 1 of this Article, such research data will be considered for acceptance for review.

Article 14. Requirements for clinical data to ensure safety and efficacy in the registration dossier for new drug combinations and biosimilars

1. New drug combinations must have complete clinical data in accordance with the guidelines of the US FDA, EMA, or WHO regarding the clinical development of fixed-dose combination drugs as implemented in Appendix IV attached to this Circular.

2. Biosimilars must have complete clinical data in accordance with the guidelines for developing biosimilars issued by the Ministry of Health of Vietnam or the WHO. Guidelines from the US FDA, EMA, and guidelines based on these guidelines are accepted. The WHO, US FDA, and EMA guidelines are as specified in Appendix IV attached to 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 drugs

1. For drugs approved for circulation in the country of origin as prescription drugs (except in cases where the drug is manufactured 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 regulatory agencies specified in Clause 10, Article 2 of this Circular, must have clinical data meeting one of the following conditions:

a) Have clinical data of the similar drug itself, permitted for use by the owner. The clinical data of the similar drug must comply with the provisions of Article 13 of this Circular;

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

2. For non-prescription drugs as defined by the country of origin (except in cases where the drug is manufactured in Vietnam and the case specified 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 in at least one country worldwide, must have clinical data meeting one of the following conditions:

a) Have clinical data of the similar drug itself, permitted for use by the owner. The clinical data of the similar drug must comply with the provisions of Article 13 of this Circular;

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

3. For drugs approved for circulation and classified as non-prescription drugs by at least one of the reference regulatory agencies specified in Clause 9, Article 2 of this Circular, must have explanatory documents and evidence proving the use of the active ingredients in the drug (regarding indications, dosages, routes of administration, target populations) clearly recorded in the National Pharmacopoeia of Vietnam, Vietnamese Pharmacopoeia, Pharmacopoeia, or other documents accepted by one of the reference regulatory agencies specified in Clause 9, Article 2 of this Circular.

Article 16. Requirements for clinical data in the registration dossier for chemical drugs with different dosage forms, concentrations, routes of administration, dosages, indications, patient populations compared to the original drug that has been approved for circulation in Vietnam.

For chemical drugs with different dosage forms, concentrations, routes of administration, dosages, indications, patient populations compared to the original drug that has been approved for circulation in Vietnam or with new formulations affecting the pharmacokinetics of the drug, there must be a clinical dossier as prescribed in Article 13 of this Circular.

Article 17. Requirements for clinical data for drugs that have been granted a registration certificate for circulation in Vietnam but have changes or additions related to clinical data compared to the approved registration dossier.

Chemical drugs, vaccines, biological products, traditional medicine drugs that have been granted a registration certificate for circulation in Vietnam and have changes or additions related to clinical data compared to the approved registration dossier must supplement clinical data according to the provisions set out in Appendix II attached to this Circular.

Article 18. 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 not meeting the requirements stipulated in Article 13 of this Circular may be exempted from one or several phases of clinical trials (including reduction of clinical data) upon decision by the Minister of Health based on the advisory opinion of the Advisory Council for Drug Registration when they fall under any of the following cases:

1. Drugs urgently needed for national defense, security, epidemic prevention, disaster relief, which are not available on the market and cannot be replaced by other drugs.

2. Drugs that have been approved for circulation by at least two of the reference regulatory authorities specified in Clause 9, Article 2 of this Circular or have been approved for circulation by the United States (US FDA) or the European Medicines Agency (EMA) based on reduced clinical data as required by these authorities.

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

4. Vaccines, biological products produced in Vietnam through technology transfer of one or more stages of the production process of finished products, where the vaccines, biological products prior to technology transfer meet the requirements stipulated in Clause 1, Articles 13 and 14 of this Circular.

Article 19. Requirements for clinical data in the registration dossier for new traditional medicine drugs.

1. Requirements for clinical data to ensure safety and efficacy in the registration dossier for new traditional medicine drugs.

a) Clinical studies of the drug, data in the clinical dossier must comply with the Preclinical and Clinical Research Guidelines for Traditional Medicine Drugs issued by the Ministry of Health or recognized organizations in Vietnam, including: WHO Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines or regulatory authorities specified in Clause 10, Article 2 of this Circular. In cases where research was conducted before the issuance of such regulations and guidelines on drug development, the research data will be considered acceptable for evaluation.

b) Traditional medicine drugs with data extracted from the following sources are accepted as clinical data for assessing the safety and efficacy of the drug:

- Monographs related to the safety and efficacy of the drug mentioned in Vietnamese or international pharmacopoeias and pharmaceutical compendia;

- 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 published scientific works;

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

2. Traditional medicine 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) Traditional medicine drugs with the same active ingredients, herbal mass, indications, and route of administration as another traditional medicine drug that has been granted a registration certificate (including cases where the registration certificate has expired), except for traditional medicine drugs identified as traditional Chinese medicine and not indicated for diseases listed in the Disease List issued by the Minister of Health pursuant to Point b, Clause 1, Article 89 of the Pharmacy Law.

b) If a traditional medicine drug has the same active ingredients, herbal mass, indications, and route of administration as a newly approved traditional medicine drug 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 Pharmacy Law, it can only be considered for approval for circulation when the other traditional medicine drug has been circulating for at least five years.

Article 20. Criteria for determining cases eligible for exemption from one or several clinical trial phases before granting marketing authorization

Medicinal drugs that have not met the requirements stipulated in Article 19 of this Circular shall be considered for exemption from one or several clinical trial phases (including exemption from clinical data) by the Minister of Health based on the advisory opinion of the Advisory Council for Drug Registration upon meeting one of the following conditions:

1. Drugs urgently needed for national defense, security, epidemic prevention, disaster relief, which are not available on the market and cannot be replaced by other drugs.

2. The drug has been granted marketing authorization by at least one of the reference regulatory authorities specified in Clause 9 and 10, Article 2 of this Circular based on a reduced clinical dossier.

3. The drug is intended 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 cases exempted from clinical trials as stipulated in Clause 3, Article 21 of this Circular.

4. The drug involves a new combination of medicinal materials previously used as drugs in Vietnam and is not intended 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 21. Criteria for determining cases eligible for exemption from clinical trials in Vietnam before granting marketing authorization

1. A generic drug with the same active ingredient, dosage, concentration, route of administration, method of administration, dose, indication, patient population, and formulation as another drug already granted registration.

2. A new drug (excluding vaccines) that has been granted marketing authorization in at least one country worldwide and has complete clinical data on safety and efficacy as stipulated in Articles 13 and 19 of this Circular.

3. A medicinal drug that has been granted registration prior to the effective date of the Medicine Law and is not intended for diseases listed in the Disease List issued by the Minister of Health.

4. A vaccine that meets the provisions of Point g, Clause 4, Article 23 of this Circular, produced entirely on the production lines of member countries specified in Clause 10, Article 2 of this Circular, and has complete clinical data on safety and efficacy as stipulated in Article 13 of this Circular.

Article 22. Criteria for determining cases required to conduct Phase IV clinical trials in Vietnam

Drugs that have been granted registration but require additional evaluation of safety and efficacy based on the advisory opinion of the Advisory Council for Drug Registration.

Chapter III

APPLICATION FOR DRUG REGISTRATION AND RAW MATERIALS FOR DRUGS

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

Article 23. Provisions for documents in the application for granting, extending, amending, and supplementing drug registration certificates and raw materials for drugs

1. Documents issued by foreign regulatory authorities must be legalized according to the laws on legalization of foreign public documents, except for cases exempted by law.

2. Permits, certificates, confirmations, registrations (collectively referred to as legal documents) in the dossier must still be valid at the time of receipt as recorded on the Application Receipt Form and must be in English or Vietnamese. In cases where the legal document does not indicate its validity period, the validity period will be calculated as 24 months from the date of issuance.

3. Legal documents must be original or certified copies:

a) Originals must bear full signatures, names of signatories, and stamps of competent state management agencies of the issuing country;

b) Certified copies must be certified by authorized Vietnamese agencies according to Vietnamese laws on certification of copies from originals. In necessary cases, the original must be presented for verification;

c) In cases where the legal document is an electronic version that does not fully display the signature, name of the signatory, and stamp of the competent state management agency of the issuing country, the registering entity must provide a document providing information about the website link (English website) of the issuing authority and commit to the legality of these legal documents.

4. Provisions for Certificates of Pharmaceutical Product (CPP):

a) The CPP must bear the signature, name of the signatory, issuance date, and stamp of the issuing authority;

b) The CPP must be issued by a national-level pharmaceutical regulatory authority;

In cases where the CPP is issued by a pharmaceutical regulatory authority but not a national-level pharmaceutical regulatory authority: The drug registering entity must provide legal documents proving that this authority is competent and that the national pharmaceutical regulatory authority in that country does not issue CPPs according to local laws;

In cases where the CPP is issued by an authority other than a pharmaceutical regulatory authority: The drug registering entity must provide documents proving that this authority is competent and that the pharmaceutical regulatory authority in that country does not issue CPPs according to local laws;

c) The signature, name of the signatory, and stamp of the issuing authority of the CPP must be certified by an authorized body; if this confirmation is not in English, it must be translated and notarized into Vietnamese or English;

d) The content of the CPP must include all information as prescribed in Model 7/TT attached to this Circular and the following contents:

- The formulation of the drug, specifying the name, components, concentration, and quantity of each active ingredient, medicinal material, excipient; for soft gel capsules and hard gel capsules, additional information on the formula of the capsule shell must be provided;

- Finished product standards, active ingredient standards, medicinal material standards, name, and address of the manufacturing facility for active ingredients and medicinal materials;

- If the drug is manufactured by multiple facilities, the CPP must clearly specify the name, address, and role of each facility;

- If the CPP does not contain information on the drug manufacturing facility complying with Good Manufacturing Practice (GMP), the registering entity must submit GMP certificates of all facilities complying with the provisions of Clauses 1, 2, and 3 of this Article;

- Any appendices accompanying the CPP (if any) must be confirmed by the issuing authority.

d) For generic drugs, herbal medicines, probiotic live biotherapeutic products (digestive enzymes), extended, changed, or supplementary registration drugs: The Certificate of Pharmaceutical Product (CPP) confirms that the drug has been authorized and marketed in the country of production. In cases where the drug has not been authorized for marketing in the country of production or has been authorized but not actually marketed in the country of production, the registering entity must provide a CPP confirming that the drug has been authorized and marketed in one of the countries specified in Clause 10, Article 2 of this Circular.

e) For new chemical drugs and imported live biotherapeutic products, excluding probiotic live biotherapeutic products (digestive enzymes): A CPP issued by the country of production and a CPP issued by one of the other regulatory authorities specified in Clause 10, Article 2 of this Circular confirming that the drug has been authorized and actually marketed.

g) For imported vaccines: A CPP issued by the country of production and a CPP issued by one of the other regulatory authorities specified in Clause 9, Article 2 of this Circular confirming that the vaccine has been authorized and actually marketed.

h) For generic drugs with a bioequivalence study report: A CPP issued by one of the regulatory authorities specified in Clause 10, Article 2 of this Circular confirming that the drug has been authorized and actually marketed.

In cases where there is no CPP meeting the requirements set forth herein, there must be a bioequivalence study report of the drug conducted at a bioequivalence testing service business establishment in Vietnam or at a bioequivalence testing facility recognized by the Minister of Health according to the regulations of the Ministry of Health or pursuant to international agreements to which Vietnam is a party.

i) For drugs proposed to be classified as original brand-name drugs, a CPP issued by one of the regulatory authorities specified in Clauses 9 and 10, Article 2 of this Circular, except for drugs produced in Vietnam.

k) For imported drugs, vaccines, and live biotherapeutic products that cannot provide a CPP meeting the requirements set forth in points d, e, g, and h of this clause, the Minister of Health shall consider and decide based on the advisory opinion of the Advisory Council for Drug Registration when the drug has been authorized for marketing by at least one regulatory authority worldwide and falls under one of the following circumstances:

- Drugs, vaccines, and live biotherapeutic products to meet the needs for national defense, security; prevention, control of epidemics, diseases, mitigation of disaster consequences, catastrophes, and drugs serving state health programs;

- Vaccines used in the national expanded immunization program where there is no alternative vaccine available on the market in terms of quantity, quality, safety, efficacy, or cost of vaccine usage;

- Other special cases with mutual recognition agreements between regulatory authorities regarding conditions for manufacturing and marketing of drugs, vaccines, and live biotherapeutic products.

l) Information displayed on the CPP must be consistent with relevant information in the drug registration dossier.

5. The application form and other administrative documents in the dossier must be signed and stamped directly by one of the positions of Chairman of the Board of Members, Board of Directors, General Director, Director of the entity, or a person authorized by those individuals, without using a stamp signature.

6. The power of attorney shall be implemented according to Model 8/TT issued together with this Circular and required to be submitted in the following cases:

a) The power of attorney shall be named after the registering entity according to Model 8A/TT issued together with this Circular. The power of attorney named after the registering entity for foreign drugs must be certified and legalized according to the regulations.

Each dossier must be accompanied by an original or certified copy of the power of attorney.

b) Power of attorney for signing the registration dossier according to Model 8B/TT issued together with this Circular; in cases where the person authorized to sign the dossier is not the head of the representative office, the power of attorney must have the seal and signature confirmation of the head of the representative office in Vietnam.

Each dossier must be accompanied by an original or certified copy of the power of attorney bearing the confirmation seal of the representative office (in case of a foreign registering entity) or the confirmation seal of the domestic registering entity.

7. A certified copy of the technology transfer agreement with the seal confirmation of the registering entity or the manufacturing entity or the representative office (in case of a foreign registering entity).

8. Certificate of eligibility for pharmaceutical business operations with one of the business forms: production, wholesale, export, import of drugs, drug ingredients (for domestic registering entities).

9. License for establishing a Representative Office in Vietnam.

In cases where the name and address of the registering entity on the License for Establishing a Representative Office in Vietnam differ from the name and address on the legal documents of the registering entity issued by the competent authority of a foreign country, evidence must be provided.

10. Legal documents issued by the competent authority of a foreign country authorizing at least one of the following business forms: production, wholesale, export, import of drugs, drug ingredients (for foreign registering entities).

In cases where the registering entity for drugs is also the manufacturing entity listed on the CPP, submission of the legal documents as stipulated in this clause is not required.

In cases where countries do not issue licenses for production, wholesale, export, or import of drugs, drug ingredients, a license for establishment or business registration with a scope of business including at least one of the following: production, wholesale, export, import of drugs, drug ingredients, along with a certificate from the competent authority certifying that the entity meets the conditions and is currently operating in pharmaceuticals or one of the Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Supply Practice (GSP), or Good Storage Practice (GSP) certificates.

For registering entities for drug ingredients, in cases where the host country does not issue a pharmaceutical business license for entities dealing in drug ingredients, acceptance of legal documents according to the regulations of the host country, which include a determination of the business scope of the entity as one of the following: production, wholesale, export, import of drug ingredients, is permitted.

11. In case the registration entity is already listed in the directory of drug registration entities published on the website of the Drug Administration Department, it shall not be required to submit the documents specified in Clauses 8, 9, and 10 of this Article.

12. The legal documents of the production facilities for active pharmaceutical ingredients, excipients, gelatin capsules, semi-finished herbal materials, and herbal materials (for the production of traditional medicine) proving compliance with Good Manufacturing Practice (GMP) may be one of the following types of documents:

a) GMP certificate;

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

c) Certificate from the competent authority (CPP) for active pharmaceutical ingredients containing information on GMP compliance;

d) Certificate of Suitability (CEP) issued by the European Pharmacopoeia.

13. The drug label samples, raw material labels, and the actual drug user instructions circulated in the country of manufacture or the country issuing the CPP must bear the confirmation stamp of the representative office, the registration entity, or the production facility. If the drug user instructions in the country of origin are not in English, a Vietnamese translation confirmed by the representative office, the registration entity, or the production facility must be submitted.

14. The drug label samples, raw material labels, and the proposed drug user instructions for circulation in Vietnam must comply with the labeling regulations stipulated by the Minister of Health and the specific requirements set forth below:

a) The proposed label and user instruction samples must bear the confirmation stamp of the representative office, the registration entity, or the production facility;

b) The outer packaging label of drugs and raw materials must be printed with a barcode, QR code, or DataMatrix Code (DMC) according to the schedule specified in Point 1, Clause 1, Article 50 of this Circular.

15. In cases where the drug manufacturing facility or raw material manufacturing facility is listed in the directory of production facilities published on the website of the Drug Administration Department as having been evaluated and found to comply with GMP, there is no requirement to submit an evaluation report on compliance with Good Manufacturing Practices in the drug registration dossier.

16. Quality standards, testing methods, test reports, and stability study documentation (applicable to both the active pharmaceutical ingredient section and the finished product section) must be original documents bearing signatures and confirmation stamps from the production facility; if copies are submitted, they must be confirmed by the registration entity (accepting the stamp of the representative office for foreign drugs).

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

17. Regulations concerning test reports, results of quality standard assessments, and experimental testing methods in Vietnam:

Test reports, results of quality standard assessments, and experimental testing methods (for production facilities that have not yet met GMP requirements according to the Ministry of Health's schedule or those notified by the Drug Administration Department in accordance with Appendix III attached to this Circular) must be originals or certified copies confirmed by state drug testing laboratories meeting Good Laboratory Practice (GLP) standards or drug testing service providers who have obtained a business license appropriate to their scope of activities.

18. The certificate permitting the production or circulation of raw materials 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 certificate.

Article 24. General provisions on administrative documents in the application dossier for issuing, extending, changing, or supplementing the drug registration certificate

Administrative documents include:

1. The registration form according to Model 6/TT issued together with this Circular.

2. Power of attorney (if any) according to Model 8/TT issued together with this Circular.

3. Certificate of business conditions for pharmaceuticals for the registering entity in Vietnam.

4. Legal documents for the registering entity in foreign countries.

5. License to establish a representative office in Vietnam for the registering entity in foreign countries.

6. Certificate of Good Manufacturing Practice (GMP) according to Model 7/TT issued together with this Circular.

7. Sample labels of drugs and raw materials for drugs and the patient information leaflet expected to be circulated.

8. Sample labels of drugs and raw materials for drugs and the patient information leaflet actually circulating in the country of production or the country granting the GMP certificate.

9. Product characteristics summary for new chemical drugs, vaccines, and biological products according to Model 9/TT issued together with this Circular.

10. Evaluation documents regarding compliance with Good Manufacturing Practices (GMP) for cases stipulated in Article 95 of Decree No. 54/2017/NĐ-CP for foreign drug manufacturing facilities when applying for circulation in Vietnam.

11. Legal documents of the manufacturing facility for active pharmaceutical ingredients, excipients, gelatin capsules, semi-finished herbal medicines, and medicinal herbs.

12. Certificate of permission to produce or circulate raw materials for drugs in the country of production.

13. Certificate of Good Laboratory Practice (GLP) of the testing facility for cases stipulated in Clause 17, Article 23 of this Circular.

14. Risk management plan (for vaccines) according to Model 10/TT issued together with this Circular.

15. Technology transfer agreement for technology transferred drugs.

16. Safety, efficacy, and usage reports of drugs according to Model 2/TT issued together with this Circular.

17. Circulation report of drugs and raw materials for drugs according to Model 11/TT issued together with this Circular.

18. Certificates, intellectual property protection documents, agreements transferring rights to intellectual property objects, and documents certifying the origin of raw materials (GACP, CEP, domestic herbal medicine sources, imported herbal medicine sources, etc.) and related documents (if any).

19. Copy of the drug registration certificate for circulation in Vietnam.

Section 2. APPLICATION DOSSIER FOR ISSUING, EXTENDING, CHANGING, OR SUPPLEMENTING THE DRUG REGISTRATION CERTIFICATE

Article 25. Quality Documents in the Application Dossier for Issuing, Extending, Changing, or Supplementing the Drug Registration Certificate for Chemical Drugs, Vaccines, and Biological Products

Quality documents shall be implemented in accordance with the guidance in Part II - ACTD or Component 3-ICH-CTD and the following regulations:

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

a) A batch release certificate issued by the competent authority of the country granting the GMP certificate as prescribed;

b) Test report, quality standards, and testing methods confirmed by the National Institute of Hygiene and Epidemiology's Vaccine and Biological Product Testing Center;

2. For rare drugs and drugs for special treatment needs:

a) Rare drugs for treating rare diseases: existing stability data in accordance with ASEAN or ICH guidelines;

b) Drugs necessary for special treatment needs: existing stability data in accordance with ASEAN or ICH guidelines decided by the Minister of Health based on the opinion of the Advisory Council for Drug Registration and Raw Material Registration in cases where the registering entity proves that the drug cannot be stored under climate zone IVb conditions as prescribed by ASEAN.

3. In cases where the manufacturing facility uses raw materials for drugs already registered for circulation in Vietnam:

a) There is no requirement to submit quality-related documents for raw materials and documents specified in Clause 11, Article 24 of this Circular in the finished drug registration dossier.

b) The registering entity must submit:

- One test report for raw materials for drugs conducted by the finished drug manufacturing facility, which must include all quality criteria at equivalent or stricter levels than those in the raw material manufacturer's quality standards;

- One test report for raw materials for drugs conducted by the raw material manufacturing facility.

4. For technology transferred drugs in Vietnam:

a) The entire quality dossier of the drug before technology transfer, implemented in accordance with the guidance in Part II - ACTD specified in Appendix I issued together with this Circular or Component 3-ICH-CTD of the drug before technology transfer (in cases where the drug before technology transfer has not been granted a registration certificate for circulation in Vietnam);

b) Detailed comparison table of changes and supplements (if any) between the drug before technology transfer and the registered drug, guided by Appendix II issued together with this Circular;

c) Active Pharmaceutical Ingredient (API) section dossier of the registered drug provided by the technology recipient when there is a change in API manufacturers compared to the drug before technology transfer;

d) Finished product section dossier of the registered drug, carried out by the technology recipient, including:

- Production process of the registered drug.

- Process validation report (for production stages carried out by the technology recipient).

- Suitability evaluation report of analytical procedures (which may be replaced by the analytical procedure transfer dossier jointly executed by the technology donor and recipient).

- Batch analysis data (Finished Product Test Report).

- Stability study report of the registered drug. If the drug before technology transfer has already been granted a registration certificate for circulation in Vietnam or has suitable stability data in accordance with ASEAN stability research guidelines, accept stability data applicable to major or minor changes (depending on the changes between the drug before technology transfer and the registered drug) as guided by ASEAN stability research guidelines.

- A biological equivalence study report of the registered drug (for original brand-name drugs proposed for publication or drugs required to submit a biological equivalence study report according to Circular No. 08/2010/TT-BYT dated April 26, 2010, issued by the Minister of Health on guidelines for bioavailability and bioequivalence studies when registering drugs, or drugs not required to submit a biological equivalence study report according to the regulations of the Minister of Health but the registration entity requests classification as a drug with proven biological equivalence). In cases where all of the following conditions are met, it may be replaced by a dissolution equivalence study report between the registered drug and the drug before technology transfer:

+ The drug before technology transfer has been granted a circulation registration certificate in Vietnam and has been published as an original brand-name drug with proven biological equivalence.

+ The registered drug must be similar to the drug before technology transfer regarding the drug formulation, raw material manufacturer used in production, quality standards, and analytical procedures for raw materials used in production, production process, equipment used in production, and environmental conditions during production. Any changes related to these contents, if any, must belong to levels that do not require submission of a post-change biological equivalence study report of the drug according to the provisions in the scale-up batch and post-approval change guidance for solid oral dosage forms of US-FDA (SUPACs), and the dossier must provide relevant documents for each change specified in these guidelines.

5. For drugs packaged secondarily in Vietnam

The entire quality dossier part of the drug before secondary packaging in Vietnam according to the guidance in Part II - ACTD or Section 3-ICH-CTD in the case where the drug has not yet been granted a circulation registration certificate in Vietnam before technology transfer.

6. For drugs proposed to be implemented under the abbreviated review procedure

a) Drug substance dossier section:

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

- Name and address of the drug substance manufacturing facility, semi-finished product containing the drug substance;

- Quality standards and testing methods for the drug substance, semi-finished products containing the drug substance. In cases where the registered drug follows the Vietnamese Pharmacopoeia standard or the reference pharmacopoeia standard according to the regulations of the Ministry of Health, only the name of the pharmacopoeia, the version of the pharmacopoeia applied, or the current pharmacopoeia should be recorded;

- One test report of the drug substance, semi-finished product from the drug substance manufacturing facility, semi-finished product, and one test report of the drug substance, semi-finished product from the finished drug manufacturing facility;

- For drug substances in semi-finished form, there must also be a formulation and production process of the semi-finished product containing the drug substance from the semi-finished product manufacturing facility.

b) Finished product dossier section:

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

- Quality standards and testing methods for the finished drug. In cases where the registration follows the Vietnamese Pharmacopoeia standard or the reference pharmacopoeia standard according to the regulations of the Ministry of Health, the name of the pharmacopoeia, the version of the pharmacopoeia, or the current pharmacopoeia should be recorded;

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

- Finished product test report;

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

- Stability of the finished drug.

c) Remaining quality dossier documents shall be carried out according to the guidance in Part II - ACTD or Section 3-ICH-CTD and stored at the registration entity and the manufacturing facility.

Documents stipulated in this Article must be implemented according to the following regulations:

a) Apply the provisions in Appendix I promulgated together with this Circular, including:

- ASEAN Common Technical Document (ACTD);

- Stability study guidance;

- Production process validation guidance;

- Analytical method validation guidance;

- Bioavailability and bioequivalence study guidance;

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

Article 26. Preclinical data in the application dossier for the issuance, extension, amendment, or supplement of the drug registration certificate for chemical drugs, vaccines, and biological products.

Preclinical data shall be prepared in accordance with the guidelines set out in Part III-ACTD or Section 4-ICH-CTD.

For probiotic biological products (digestive enzymes) originating from strains of bacteria with similar concentrations, contents, indications, and dosages to those already permitted by one of the regulatory authorities specified in Clause 9 and Clause 10 of Article 2 of this Circular, there is no need to submit preclinical data.

Article 27. Clinical data in the application dossier for the issuance, extension, amendment, or supplement of the drug registration certificate for chemical drugs, vaccines, and biological products.

Clinical data shall be prepared in accordance with the guidelines set out in Part IV-ACTD or Section 5-ICH-CTD.

For probiotic biological products (digestive enzymes) originating from strains of bacteria with similar concentrations, contents, indications, and dosages to those already permitted by one of the regulatory authorities specified in Clause 9 and Clause 10 of Article 2 of this Circular, clinical data is not required.

Article 28. Application dossier for the issuance, extension, amendment, or supplement of the drug registration certificate for chemical drugs, vaccines, and biological products.

1. The application dossier for the issuance of a new chemical drug registration certificate, vaccine, or biological product registration certificate includes:

a) Administrative documents as prescribed in Clause 1, Clause 2, Clause 7, Clause 9, Clause 11, Clause 13, Clause 14, and Clause 18 of Article 24 of this Circular, and the following documents:

- Documents prescribed in Clause 3 of Article 24 of this Circular for domestic registrants;

- Documents prescribed in Clause 4 and Clause 5 of Article 24 of this Circular for foreign registrants;

- Documents prescribed in Clause 6, Clause 8, and Clause 10 of Article 24 of this Circular for foreign drug registration dossiers.

b) Quality-related documents as prescribed in Article 25 of this Circular;

c) Preclinical data as prescribed in Article 26 of this Circular;

d) Clinical data as prescribed in Article 27 of this Circular;

đ) In cases where the registrant requests classification of the original brand name when submitting the application dossier for the issuance of a drug registration certificate, it shall be carried out in accordance with the provisions of point a, b, c, and d of Clause 1 of this Article and point b of Clause 1 of Article 9 of this Circular.

2. The application dossier for the issuance of a registration certificate for generic drugs includes:

a) Administrative documents as prescribed in Clause 1, Clause 2, Clause 7, Clause 11, Clause 13, and Clause 18 of Article 24 of this Circular, and the following documents:

- Documents prescribed in Clause 3 of Article 24 of this Circular for domestic registrants;

- Documents prescribed in Clause 4 and Clause 5 of Article 24 of this Circular for foreign registrants;

- Documents prescribed in Clause 6, Clause 8, and Clause 10 of Article 24 of this Circular for foreign drug registration dossiers.

b) Quality-related documents as prescribed in Article 25 of this Circular.

3. The application dossier for the extension of the drug registration certificate includes:

a) Administrative documents as prescribed in Clause 1, Clause 2, Clause 14, Clause 16, Clause 17, Clause 18, and Clause 19 of Article 24 of this Circular, and the following documents:

- Documents prescribed in Clause 3 of Article 24 of this Circular for domestic registrants;

- Documents prescribed in Clause 4 and Clause 5 of Article 24 of this Circular for foreign registrants;

- Documents prescribed in Clause 6 and Clause 10 of Article 24 of this Circular for foreign drug registration dossiers.

b) Relevant documents as prescribed in Appendix II attached to this Circular for cases where there are changes to the administrative dossier at the time of extending the drug registration certificate.

If the registrant has submitted changes to the administrative dossier before submitting the extension application dossier but such changes have not yet been approved, there is no need to resubmit these documents in the extension application dossier.

4. The application dossier for the amendment or supplementation of the drug registration certificate includes:

a) A request form for amending or supplementing the drug registration certificate according to Form 6/TT issued together with this Circular;

b) Corresponding documents related to major and minor amendments as prescribed in Appendix II attached to this Circular. For vaccines owned by the same product owner or produced by the same production facility or the holder of the drug registration certificate who accepts a change in the production site within the same country or outside the country where the registration certificate was issued.

5. The application dossier for the issuance of a drug registration certificate through technology transfer

a) The application dossier for the issuance of a drug registration certificate through technology transfer for drugs that have an existing valid registration certificate in Vietnam:

- Administrative documents as prescribed in Clause 1, Clause 2, Clause 7, Clause 13, Clause 14, Clause 15, Clause 16, Clause 17, Clause 18, and Clause 19 of Article 24 of this Circular, and the following documents:

+ Documents prescribed in Clause 3 of Article 24 of this Circular for domestic registrants;

+ Documents prescribed in Clause 4 and Clause 5 of Article 24 of this Circular for foreign registrants.

- Quality-related documents as prescribed in Clause 4 of Article 25 of this Circular;

- Relevant documents as prescribed in Appendix II attached to this Circular for cases where there are changes compared to the transferred drug that has already been granted a registration certificate.

b) The application dossier for the issuance of a drug registration certificate through technology transfer for drugs that do not have a registration certificate in Vietnam or whose registration certificate in Vietnam has expired:

- Dossier of the drug prior to technology transfer as prescribed in Clause 1 or Clause 2 of this Article and Clause 15 of Article 24 of this Circular;

- Quality-related documents as prescribed in Clause 4 of Article 25 of this Circular.

6. The application dossier for the issuance of a drug registration certificate for secondary packaging in Vietnam

a) The application dossier for the issuance of a drug registration certificate for secondary packaging in Vietnam for drugs that have an existing valid registration certificate in Vietnam: To be implemented in accordance with the regulations on changing the secondary packaging facility as prescribed in Appendix II attached to this Circular;

b) The application dossier for the issuance of a drug registration certificate for secondary packaging in Vietnam for drugs that do not have a registration certificate in Vietnam or whose registration certificate in Vietnam has expired:

- Dossier of the drug prior to secondary packaging as prescribed in Clause 1 or Clause 2 of this Article;

- Good Manufacturing Practice (GMP) certification of the secondary packaging facility in Vietnam;

- Quality-related documents as prescribed in Clause 5 of Article 25 of this Circular.

7. The application dossier for the issuance of a drug registration certificate through expedited review procedures

a) Administrative documents as prescribed in Clause 1, Clause 2, Clause 7, Clause 11, Clause 13, and Clause 18 of Article 24 of this Circular, and the following documents:

- Documents prescribed in Clause 3 of Article 24 of this Circular for domestic registrants;

- Documents prescribed in Clause 4 and Clause 5 of Article 24 of this Circular for foreign registrants;

- Documents prescribed in Clause 6 and Clause 8 of Article 24 of this Circular for foreign drug registration dossiers.

b) Quality-related documents as prescribed in point a and point b of Clause 6 of Article 25 of this Circular.

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

Article 29. Quality Documents in Application Documents for the Issue, Extension, Modification, and Supplementation of the Drug and Medicinal Material Registration License

1. Raw Materials

a) Production Process (applicable only to medicinal material raw materials): Detailed description of the entire process of preliminary processing and manufacturing of medicinal material raw materials. If the raw material is semi-finished medicinal material or medicinal extract, it must detail the production process of semi-finished medicinal material or medicinal extract from medicinal material raw materials (except when the semi-finished medicinal material or medicinal extract has already been issued a registration license).

b) Quality Standards and Testing Methods

- For medicinal materials not in the form of semi-finished medicinal materials: carried out according to the provisions of Circular No. 13/2018/TT-BYT dated May 15, 2018 of the Ministry of Health on the quality of medicinal materials and traditional medicine.

- For semi-finished medicinal materials, similar quality standards and testing methods for medicinal materials not in the form of semi-finished medicinal materials as stipulated in Circular No. 13/2018/TT-BYT dated May 15, 2018 of the Ministry of Health on the quality of medicinal materials and traditional medicine shall be applied.

c) Raw Material Test Report

- One test report of medicinal material from the finished drug manufacturer.

- One test report of semi-finished medicinal material or medicinal extract from the semi-finished medicinal material or medicinal extract manufacturer and one test report of semi-finished medicinal material or medicinal extract from the finished drug manufacturer.

2. Finished Products

a) Production Process

- Formula for the smallest packaging unit: name, content, concentration, weight, applicable standard of each component in the formula for one smallest packaging unit. In case of production from semi-finished medicinal material or medicinal extract, the corresponding weight of medicinal material for semi-finished medicinal material or medicinal extract or the ratio of medicinal extract, semi-finished medicinal material to initial medicinal material or accompanied by the percentage content (%) of medicinal substance, quantified compound according to each medicinal material must be clearly stated.

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

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

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

- Equipment list: equipment name, specifications, purpose.

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

b) Quality Standards and Testing Methods

- Formula for the smallest packaging unit: name, content, concentration, weight, applicable standard of each component in the formula for one smallest packaging unit. In case of production from semi-finished medicinal material or medicinal extract, the corresponding weight of medicinal material for semi-finished medicinal material or medicinal extract or the ratio of medicinal extract, semi-finished medicinal material to initial medicinal material or accompanied by the percentage content (%) of medicinal substance, quantified compound according to each medicinal material must be clearly stated.

- Finished product standards: carried out according to the provisions of Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Ministry of Health on the quality of drugs and drug raw materials.

c) Finished Product Test Report.

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

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

Article 30. Safety and efficacy documents in the application dossier for registration, extension, change, or supplementation of drug registration certificates for herbal medicines

1. Safety and efficacy documents for herbal medicines shall be implemented according to the provisions of Appendix V attached hereto or according to the ASEAN (ACTD), ICH-CTD regulations.

2. Documents specified in point b, Clause 1, Article 19 of this Circular (if applicable).

Article 31. Application dossier for registration, extension, change, or supplementation of drug registration certificates for herbal medicines

1. Application dossier for registration of drug registration certificates for herbal medicines, including:

a) Administrative documents as prescribed in Clause 1, Clause 2, Clause 7, Clause 11, Clause 13, and Clause 18 of Article 24 of this Circular, and the following documents:

- Documents prescribed in Clause 3 of Article 24 of this Circular for domestic registrants;

- Documents prescribed in Clause 4 and Clause 5 of Article 24 of this Circular for foreign registrants;

- Documents prescribed in Clause 6, Clause 8, and Clause 10 of Article 24 of this Circular for foreign drug registration dossiers.

b) Quality documents as stipulated in Article 29 of this Circular;

c) Safety and efficacy documents as stipulated in Article 30 of this Circular;

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

a) Administrative documents as prescribed in Clauses 1, 2, 16, 17, 18, and 19 of Article 24 of this Circular and the following documents:

- Documents prescribed in Clause 3 of Article 24 of this Circular for domestic registrants;

- Documents prescribed in Clause 4 and Clause 5 of Article 24 of this Circular for foreign registrants;

- Documents prescribed in Clause 6 and Clause 10 of Article 24 of this Circular for foreign drug registration dossiers.

b) Relevant documents as prescribed in Section D of Appendix II attached hereto for cases where there are changes in administrative files at the time of extending the drug registration certificate.

If the registrant has submitted changes to the administrative dossier before submitting the extension application dossier but such changes have not yet been approved, there is no need to resubmit these documents in the extension application dossier.

3. Application dossier for change or supplementation of drug registration certificates for herbal medicines, including:

a) Application form for changing or supplementing drug registration certificates for herbal medicines according to Form 6/TT issued together with this Circular;

b) Documents corresponding to major and minor changes as prescribed in Section D of Appendix II attached hereto.

Chapter 4. APPLICATION DOSSIER FOR RAW MATERIALS USED IN DRUGS

Article 32. Quality documents in the application dossier for registration, extension, change, or supplementation of drug registration certificates for raw materials used in drugs

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

2. For semi-finished products containing drug substances: Implement according to the ACTD dossier as if registering finished drugs, wherein the finished product section of the dossier is replaced by the semi-finished product registration dossier; formulas for a single dose and smallest unit package are replaced by production batch formulas.

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

a) Formulation for semi-finished herbal medicine, pre-mixed excipient, and capsule shell: 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: thoroughly detailing each step in every stage of the production process, including all technical parameters of each stage.

- Equipment list: equipment name, specifications, purpose.

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

c) Quality standards and testing methods

- For semi-finished medicinal materials, similar quality standards and testing methods for medicinal materials not in the form of semi-finished medicinal materials as stipulated in Circular No. 13/2018/TT-BYT dated May 15, 2018 of the Ministry of Health on the quality of medicinal materials and traditional medicine shall be applied.

- For excipients and capsules: implement according to Circular No. 11/2018/TT-BYT dated May 4, 2018, of the Ministry of Health on drug and raw material quality.

d) Test report.

đ) Packaging material standards: Fully and detailedly describing packaging material, quality criteria, quality levels, and testing methods.

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

Article 33. Documents for Application for Issuance, Extension, Amendment, and Supplement of Raw Material Drug Registration Certificates

1. Documents for Application for Issuance of Raw Material Drug Registration Certificate include:

a) Part I. Administrative Documents

- Administrative documents as prescribed in Clauses 1, 2, 7, 11, 13, and 18 of Article 24 of this Circular and the following documents:

- Documents prescribed in Clause 3 of Article 24 of this Circular for domestic registrants;

- Documents prescribed in Clause 4 and Clause 5 of Article 24 of this Circular for foreign registrants;

- Documents as prescribed in Clauses 8, 10, and 12 of Article 24 of this Circular for raw material registration applications produced outside the country.

b) Quality documents as prescribed in Article 32 of this Circular;

2. Documents for Application for Extension of Raw Material Drug Registration Certificate:

a) Administrative documents as prescribed in Clauses 1, 2, 11, 17, 18, and 19 of Article 24 of this Circular and the following documents:

- Documents prescribed in Clause 3 of Article 24 of this Circular for domestic registrants;

- Documents prescribed in Clause 4 and Clause 5 of Article 24 of this Circular for foreign registrants;

- Documents as prescribed in Clauses 10 and 12 of Article 24 of this Circular for cases where raw materials are produced outside the country.

b) Related documents as prescribed in Section B of Appendix II issued together with this Circular for cases where raw materials have changes in administrative documents at the time of extension of the registration certificate.

If the registrant has submitted changes to the administrative dossier before submitting the extension application dossier but such changes have not yet been approved, there is no need to resubmit these documents in the extension application dossier.

3. Documents for Application for Amendment and Supplement of Raw Material Drug Registration Certificate include:

a) Request form for amendment and supplement of drug registration certificate according to Form 06/TT issued together with 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 ISSUANCE, EXTENSION, AMENDMENT, AND SUPPLEMENT OF DRUG AND RAW MATERIAL DRUG REGISTRATION CERTIFICATES; SEQUENCE OF REVIEW FOR IMPORTATION OF DRUGS WITHOUT REGISTRATION CERTIFICATE

Article 34. Cases to be processed through expedited review procedures

1. Drugs listed in the Rare Drugs Directory issued by the Minister of Health.

2. Drugs meeting urgent needs for national defense, security, epidemic control, disaster relief, and post-disaster recovery.

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

4. Vaccines pre-evaluated and found satisfactory by the World Health Organization, vaccines used in national expanded immunization programs.

5. Specialized therapeutic drugs, drugs with special dosage forms, including no more than two (two) similar drugs (same active ingredient, same dosage form, same strength) having valid drug registration certificates in Vietnam at the time of application submission, including:

a) Cancer treatment drugs;

b) New generation antiviral drugs;

c) New generation antibiotics;

d) Drugs used in dengue fever, tuberculosis, malaria treatment.

6. Domestic drugs, including:

a) Drugs manufactured under contract or technology transfer in Vietnam for cancer treatments, vaccines, biologics, new generation antiviral drugs, and new generation antibiotics;

b) Herbal drugs with national, ministry-level, or provincial-level scientific and technological projects that have been successfully completed and meet requirements, drugs entirely produced from domestic herbal sources that comply with Good Agricultural and Collection Practices (GACP) as per WHO standards;

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

7. New drugs (for cancer treatment, new generation antivirals, new generation antibiotics), biologics.

8. Original brand drugs manufactured under contract or technology transfer in Vietnam.

Article 35. Cases for Expedited Review

The drug registration dossier shall be reviewed through the expedited review process when meeting the following conditions simultaneously:

1. The drug is produced at a facility that the Drug Administration regularly evaluates for compliance with good manufacturing practices for drugs.

2. The drug is included in the List of Over-the-Counter Drugs.

3. The drug is not a modified release formulation.

4. The drug is not intended for direct application to the eye.

Article 36. Authority to issue, extend, change, and supplement the drug circulation registration certificate, raw material for drug production

1. The Minister of Health assigns the Drug Administration to organize the review of dossiers, issue, extend the drug circulation registration certificate, raw material for drug production, approve major changes to the drug circulation registration certificate including changes in indications, dosage, target population, and announce the original brand name, and bioequivalent study reported drugs based on the review opinions of the dossier, advisory opinions of the Advisory Council for issuing the drug circulation registration certificate, raw material for drug production.

2. The Minister of Health assigns the Drug Administration to review dossiers and approve changes and supplements to the drug circulation registration certificate, raw material for drug production, except for major changes as stipulated in Clause 1 of this Article.

Article 37. General Provisions

1. The dossier is submitted online, directly, or sent via postal service to the Drug Administration.

2. After receiving the complete dossier, the Drug Administration issues the applicant a Receipt of Dossier Acceptance Form No. 12/TT accompanying this Circular.

3. For dossiers of imported drugs without a circulation registration certificate, the acceptance of dossiers shall be carried out according to the provisions of point b, Clause 1, Article 77 of Decree No. 54/2017/NĐ-CP.

4. Organization of dossier review for issuance, extension, change, and supplementation of the drug circulation registration certificate, raw material for drug production, and dossiers of imported drugs without a circulation registration certificate:

a) The Drug Administration transfers the dossier to experts for review or units determined by the Minister of Health (hereinafter referred to as the reviewing unit) to organize the review based on the list of experts for review established and approved by the Drug Administration or the reviewing units.

b) Based on the consolidated review opinions of the experts for review, the reviewing unit specified in point a of this clause, and considering related information, the Drug Administration is responsible for proposing the issuance, extension, change, and supplementation or non-issuance, non-extension, non-change, non-supplementation of the drug circulation registration certificate, raw material for drug production; issuance, non-issuance, or non-issuance of import permit for drugs without a circulation registration certificate. The proposal opinion of the Drug Administration is reflected in the review minutes.

c) The Drug Administration submits the review and advisory opinions of the Advisory Council for issuing the drug circulation registration certificate, raw material for drug production on the proposals of the Drug Administration specified in point b of this clause for the following cases:

- Issuing, not issuing the drug circulation registration certificate, raw material for drug production;

- Extending, not extending the drug circulation registration certificate, raw material for drug production;

- Approving, not approving major changes to the drug circulation registration certificate concerning changes in indications, dosage, target population;

- Announcing, not announcing the original brand name, drugs with bioequivalence study reports;

- Issuing, not issuing the import permit for drugs without a circulation registration certificate;

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

Article 38. Procedures for Issuing Drug Registration Certificates, Review Process for Importing Drugs Without Registration Certificates

1. Within a maximum period of twelve months from the date of receiving complete application files for issuing drug registration certificates (except for cases stipulated in Article 41 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 three months from the date of receiving complete application files, the Department of Medicines Management shall conduct a review, classify, and forward the files to experts or reviewing units. Within six months from the date of receiving the files from the Department of Medicines Management, the experts and reviewing units must complete the review report and submit it to the Department of Medicines Management for consolidation and recommendation according to Clause 4, Article 37 of this Circular.

b) Within two months from the date of receiving the review report, the Department of Medicines Management shall provide a written response to applications that do not meet the requirements, specifying the reasons. For applications recommended for issuance or requiring further review and consultation with the Advisory Council on Drug Registration, the Department of Medicines Management shall present them to the Council at its next meeting.

c) Within thirty days from the date of the Council's meeting, the Department of Medicines Management shall issue a decision to grant drug registration certificates for applications that meet the requirements; the Department of Medicines Management shall provide a written response based on the Council's conclusion for applications that do not meet the requirements, specifying the reasons.

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

The applicant must notify the Department of Medicines Management in writing of any updated information related to the safety and efficacy of the drug compared to the previously submitted application and currently under review.

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

3. Within six months from the date of receiving complete supplementary data, the Department of Medicines Management shall issue a decision to grant drug registration certificates for applications that meet the requirements; the Department of Medicines Management shall provide a written response based on the Council's conclusion for applications that do not meet the requirements, specifying the reasons.

The procedure for examining supplementary data shall be carried out according to the provisions of Clause 1 of this Article.

4. Review process for importing drugs without registration certificates:

a) Within five working days from the date of receiving complete application files, the Department of Medicines Management shall transfer the files to the experts or reviewing units.

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

b) Within twenty days from the date of receiving the reviewed report in accordance with the operational regulations of the experts:

- The Department of Medicines Management shall consolidate the review opinions of the experts or reviewing units and consider relevant information to recommend issuance, non-issuance, or denial of import permits for drugs without registration certificates.

- For applications that require presentation to the Council according to Point c, Clause 4, Article 37 of this Circular, the Department of Medicines Management shall present them to the Council at its next meeting.

- For applications recommended for non-issuance, the Department of Medicines Management shall provide a written response specifying the reasons.

c) Within five working days from the date of the Council's meeting or receipt of the Advisory Council's conclusion on drug registration certificates, the Department of Medicines Management shall issue an Import Permit for applications that meet the requirements; or provide a written response based on the Council's conclusion for applications that do not meet the requirements, specifying the reasons.

d) After receiving modified and supplemented application files from the importer, the Department of Medicines Management shall follow the provisions of Points a, b, and c of this Clause.

For applications of the Advisory Council on Drug Registration, Raw Material Registration that require modification and supplementation but do not need to be resubmitted to the Council, the Department of Medicines Management shall notify the applicant to modify and supplement; if the modified and supplemented application meets the requirements, the Department of Medicines Management shall issue the permit without resubmitting to the Council.

Article 39. Procedure for Extending the Drug Circulation Registration Certificate and Raw Material for Drugs

1. Within three months from the date of receiving complete files, the Drug Administration Department shall extend the drug circulation registration certificate and raw material for drugs. In cases where extension is not granted or has not been granted, the Drug Administration Department shall issue a written response stating the reasons. The timeframes for each step are specified as follows:

a) Within ten working days from the date of receiving complete files, the Drug Administration Department shall review, classify, and send the files to the sub-committees for examination. Within one month from the date of receiving the files from the Drug Administration Department, the sub-committees must complete the examination report and submit it to the Drug Administration Department for consolidation and conclusion according to Clause 4, Article 37 of this Circular;

b) Within fifteen working days from the date of receiving the examination reports from the sub-committees, the Drug Administration Department shall issue a written response for examination files that have not met or failed to meet the requirements, clearly stating the reasons. For examination files that have met the requirements or other cases requiring the opinion and advice of the Drug Circulation Registration Certificate Advisory Council, the Drug Administration Department shall present them to the Council at the next meeting;

c) Within fifteen working days from the date of the Council meeting, the Drug Administration Department shall issue a decision to extend the drug circulation registration certificate for files that have met the requirements; the Drug Administration Department shall issue a written response according to the Council's conclusion for examination files that have not met or failed to meet the requirements, clearly stating the reasons.

2. Within twelve months for cases requiring additional documentation, from the date the Drug Administration Department issues a notification, the registering entity must submit the required supplementary documentation. After this period, if the registering entity does not submit supplementary documentation, the submitted file will lose its validity.

The applicant must notify the Department of Medicines Management in writing of any updated information related to the safety and efficacy of the drug compared to the previously submitted application and currently under review.

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

3. Within three months from the date of receiving complete supplementary documentation, the Drug Administration Department shall issue a decision to extend the drug circulation registration certificate for files that have met the requirements; the Drug Administration Department shall issue a written response according to the Council's conclusion for examination files that have not met or failed to meet the requirements, clearly stating the reasons.

The procedure for examining supplementary data shall be carried out according to the provisions of Clause 1 of this Article.

Article 40. Procedure for Changing and Supplementing the Drug Circulation Registration Certificate and Raw Material for Drugs During the Validity Period of the Drug Circulation Registration Certificate and Raw Material for Drugs

1. Changing and supplementing the drug circulation registration certificate for significant changes in indications, dosage, target population; classifying original brand-name drugs, drugs with bioequivalence study reports

Within three months from the date of receiving complete files, the Drug Administration Department shall publish the original brand-name drugs and drugs with bioequivalence study reports, and approve significant changes in indications, dosage, and target population for drugs. In cases where approval is not granted or has not been granted, the Drug Administration Department shall issue a written response stating the reasons. The timeframes for each step are specified as follows:

a) Within ten working days from the date of receiving complete files, the Drug Administration Department shall review, classify, and send the files to the sub-committees for examination. Within one month from the date of receiving the files from the Drug Administration Department, the sub-committees must complete the examination report and submit it to the Drug Administration Department for consolidation and conclusion according to Clause 4, Article 37 of this Circular;

b) Within fifteen working days from the date of receiving the examination reports from the sub-committees, the Drug Administration Department shall issue a written response for examination files that have not met or failed to meet the requirements, clearly stating the reasons. For examination files that have met the requirements or other cases requiring the opinion and advice of the Drug Circulation Registration Certificate Advisory Council, the Drug Administration Department shall present them to the Council at the next meeting;

c) Within fifteen working days from the date of the Council meeting, the Drug Administration Department shall publish the original brand-name drugs and drugs with bioequivalence study reports, and approve significant changes in indications, dosage, and target population for files that have met the requirements. The Drug Administration Department shall issue a written response according to the Council's conclusion for examination files that have not met or failed to meet the requirements, clearly stating the reasons.

2. Changing and supplementing the drug circulation registration certificate and raw material for drugs, except for cases stipulated in Clause 1 and 3 of this Article

Within three months from the date of receiving complete files, the Drug Administration Department shall approve changes and supplements. In cases where approval is not granted or has not been granted, the Drug Administration Department shall issue a written response stating the reasons. The timeframes for each step are specified as follows:

a) Within ten days from the date of receiving complete files, the Drug Administration Department shall review, classify, and send the files to the sub-committees for examination. Within sixty days from the date of receiving the files from the Drug Administration Department, the sub-committees must complete the examination report and submit it to the Drug Administration Department for consolidation and conclusion according to Clause 4, Article 37 of this Circular;

b) Within twenty days from the date of receiving the examination reports from the sub-committees, the Drug Administration Department shall approve changes and supplements to the drug circulation registration certificate for files that have met the requirements; issue a written response for examination files that have not met or failed to meet the requirements, clearly stating the reasons.

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

Within fifteen working days from the date of receiving complete files, the Drug Administration Department shall approve changes and supplements to the drug circulation registration certificate for files that have met the requirements; issue a written response for examination files that have not met or failed to meet the requirements, clearly stating the reasons.

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

The applicant must notify the Department of Medicines Management in writing of any updated information related to the safety and efficacy of the drug compared to the previously submitted application and currently under review.

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

5. Within two months from the date of receiving complete supplementary documentation for files stipulated in Clause 1 of this Article, one month from the date of receiving complete supplementary documentation for files stipulated in Clause 2 of this Article, and ten working days from the date of receiving complete supplementary documentation for files stipulated in Clause 3 of this Article, the Drug Administration Department shall approve changes and supplements to the drug circulation registration certificate for files that have met the requirements; issue a written response for examination files that have not met or failed to meet the requirements, clearly stating the reasons.

The procedure for reviewing supplementary documentation shall be carried out according to the provisions of Clauses 1, 2, and 3 of this Article.

6. The deadline for implementing changes and supplements to the drug circulation registration certificate and raw material for drugs: not exceeding twelve months for vaccines and biological products or six months for other drugs and raw materials for drugs from the date the Drug Administration Department signs and issues the approval letter, except for special requirements of the Drug Administration Department.

7. Certain cases for changing, supplementing, registration basis of medicines, medicine production establishments updating on labels, drug usage instructions without having to submit applications or notify the Drug Administration Department include the following situations:

a) Implementing the labeling of drugs, raw materials for drugs, and drug usage instructions according to Clause 2, Article 35 of Circular 01/2018/TT-BYT dated January 18, 2018 of the Ministry of Health regarding the recording of drugs, raw materials for drugs, and drug usage instruction sheets;

b) Implementing changes or supplements to the label content and drug usage instructions in accordance with the content specified in the request document of the Drug Administration Department;

c) Except for cases where samples of labels and drug usage instructions must be resubmitted upon changes or supplements as stipulated in Appendix II issued together with this Circular, other changes related to information on labels, drug usage instructions of the registration basis and production establishments must be self-updated after being approved by the Drug Administration Department for these changes or supplements;

d) Other contents:

- Changing importation information of drugs, raw materials for drugs recorded on labels or drug usage instruction sheets;

- Correcting typographical errors on labels or drug usage instruction sheets;

- Changing the layout of sections in drug usage instruction sheets without altering the already-approved content of the drug usage instruction sheet;

- Supplementing quality standard information on labels and drug usage instructions based on the approved application file;

- Changes and supplements in accordance with the notification results of the drug registration dossier review issued by the Drug Administration Department;

Article 41. The procedure for issuing a drug circulation registration certificate shall be carried out according to the fast review process, simplified review process, and issuance of a raw material for drug circulation registration certificate;

1. Within six months from the date of receiving all necessary documents, the Drug Administration Department issues a drug circulation registration certificate. In case of non-issuance or delay in issuance, the Drug Administration Department shall issue a written response specifying the reasons. The time limits for each step are as follows:

a) Within ten working days from the date of receiving all necessary documents, the Drug Administration Department classifies and forwards the dossier to the specialized review sub-committees. Within three months from the date of receipt of the dossier from the Drug Administration Department, experts and reviewing units must complete the review report and forward it to the Drug Administration Department for consolidation and conclusion according to Clause 4, Article 37 of this Circular;

b) Within twenty working days from the date of receipt of the review reports from the sub-committees, the Drug Administration Department issues a written response for dossiers that do not meet the requirements, specifying the reasons. For dossiers that meet the requirements or require opinions from the Advisory Council for issuing drug circulation registration certificates, the Drug Administration Department shall submit them to the Council at the next meeting;

c) Within thirty working days from the date of the Council meeting, the Drug Administration Department issues a decision to grant a drug circulation registration certificate for dossiers that meet the requirements; the Drug Administration Department issues a written response according to the Council's conclusions for dossiers that do not meet the requirements, specifying the reasons;

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

The registration subject shall notify the Drug Administration Department in writing of any updated information related to the safety and efficacy of drugs, raw materials for drugs compared to the submitted dossier during the review period;

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

3. Within three months from the date of receiving supplementary documents, the Drug Administration Department issues a decision to grant a drug circulation registration certificate for dossiers that meet the requirements; the Drug Administration Department issues a written response according to the Council's conclusions for dossiers that do not meet the requirements, specifying the reasons;

The procedure for examining supplementary data shall be carried out according to the provisions of Clause 1 of this Article.

Chapter V

REVOCATION OF DRUG CIRCULATION REGISTRATION CERTIFICATE, SUSPENSION OF APPLICATION FOR ISSUE AND EXTENSION OF DRUG CIRCULATION REGISTRATION CERTIFICATE

Article 42. Documents, procedures, and authority for revoking drug registration certificates

1. Authority to revoke and responsibility to announce the revocation of drug registration certificates:

a) The Minister of Health shall instruct the Drug Administration Department to revoke drug registration certificates for drugs and raw materials for drugs in cases stipulated in Clause 1 of Article 58 of the Medicine Law;

b) Provincial Departments of Health and Health Departments of sectors shall announce the decisions of the Drug Administration Department regarding the revocation of drug registration certificates within their jurisdiction.

2. Documents for revoking drug registration certificates for drugs and raw materials for drugs in cases stipulated in point g, Clause 1 of Article 58 of the Medicine Law include:

- A request for revocation of the drug registration certificate in Vietnam from the manufacturing facility or the drug registration entity according to Model 1/TT attached to this Circular;

- Original copy of the registration certificate;

- Supporting documents (if available).

3. Procedures for revoking drug registration certificates for drugs and raw materials for drugs as stipulated in points a and b, Clause 1 of 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.

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

Within ten days from the date the competent authority of Vietnam or from the date of receiving the World Health Organization or exporting country's recommendation that the drug is not safe or effective for users, or from the date of receiving the foreign competent authority's decision to revoke the product certification, the Drug Administration Department shall issue a decision to revoke the drug registration certificate.

5. Procedures for revoking drug registration certificates for drugs and raw materials for drugs as stipulated in points d and đ, Clause 1 of Article 58 of the Medicine Law

Within thirty days from the date of the written conclusion of the competent authority regarding the falsified registration dossier or the production of drugs and raw materials at an address different from the registered address, the Drug Administration Department shall issue a decision to revoke the drug registration certificate.

6. Procedures for revoking drug registration certificates for drugs and raw materials for drugs as stipulated in point g, Clause 1 of Article 58 of the Medicine Law

Within twenty days from the date of receipt of complete documents as prescribed in Clause 2 of this Article, the Drug Administration Department shall issue a decision to revoke the drug registration certificate. In case of disagreement with the revocation request, the Drug Administration Department shall provide a written response stating the reasons.

Article 43. Provisions on suspending the acceptance of applications for issuing and extending drug registration certificates

1. Suspension of the acceptance of applications for issuing and extending drug registration certificates shall be carried out in accordance with Clauses 2, 3, and 4 of Article 100 of Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government detailing certain provisions and measures for implementing the Medicine Law.

2. The Drug Administration Department shall announce the suspension of the acceptance of applications for issuing and extending drug registration certificates.

Chapter VI

PRINCIPLES OF ORGANIZATION AND OPERATIONS OF EXPERTS AND ADVISORY BOARDS FOR ISSUING DRUG REGISTRATION CERTIFICATES

Article 44. Organization and Activities of the Advisory Council for Issuing Drug Registration Certificates and Raw Materials for Drugs

1. The Minister of Health shall establish the Advisory Council for Issuing Drug Registration Certificates and Raw Materials for Drugs. The Council shall consist of members who are experts with appropriate professional qualifications and experience to ensure the ability to review applications, provide feedback on the opinions of reviewing experts, and recommendations from the Department of Drug Management, and advise the Minister of Health on issues related to drug regulations, quality, safety, and efficacy of drugs and raw materials for drugs.

2. The Council shall be responsible for reviewing applications, advising the Minister of Health on issuing, extending, changing, and supplementing drug registration certificates and raw materials for drugs; granting import permits for drugs not yet registered in Vietnam based on the recommendations of the Department of Drug Management and other issues requested by the Minister of Health. The Council shall be accountable to the Minister of Health for its review opinions and advice.

3. Principles of Operation of the Council:

a) The Council operates under the principle of consensus, democratic concentration, objectivity, transparency, and openness. The Council's opinions must have a legal basis, scientific foundation, consider the results of application reviews by reviewing experts, rely on practical clinical evidence, and take into account the recommendations of the Department of Drug Management.

b) The Council shall convene when at least two-thirds of its members attend, and in cases where members cannot attend but submit their opinions in writing, such submissions shall be considered as attendance;

The Chairman of the Council or a person authorized by the Chairman shall preside over the Council meeting and conclude based on at least two-thirds of the attending members' agreement. Dissenting opinions from the conclusion of the Council shall be retained.

Opinions of Council members and conclusions of the Council must be recorded in the minutes of the Council meeting, including dissenting opinions from the Council's conclusion.

c) In cases where a Council meeting is not organized, the Chairman of the Council shall solicit opinions in writing from Council members;

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

The Council's concluding opinion shall be based on the consensus of at least two-thirds of the members who have submitted their opinions to the Council's Standing Office and on the basis of a consolidated report and recommendation from the Department of Drug Management;

The Council's concluding opinion shall be reflected in a Presentation Form recording the Council Chairman's or a person authorized by the Chairman's concluding opinion.

d) When necessary, the Chairman of the Council may seek additional opinions from independent experts outside the Council members before making a final conclusion. These experts may directly participate in the Council session or provide written opinions, bearing responsibilities and rights similar to those of official Council members;

e) Not violating conflict of interest principles.

4. The Department of Drug Management shall advise the Minister of Health to promulgate regulations on the organization and operation of the Advisory Council for Issuing Drug Registration Certificates and Raw Materials for Drugs, mechanisms for cooperation between the Council and reviewing experts during the issuance, extension, change, and supplementation of drug registration certificates and raw materials for drugs, and import permits for drugs not yet registered in Vietnam.

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

6. The Council's Standing Office shall be located at the Department of Drug Management.

Article 45. Organization and activities of experts reviewing drug registration files, raw material for drug registration files, and reviewing import permit application files for drugs without circulation registration certificates.

1. The Drug Administration Department shall establish expert sub-committees to review drug registration files, raw material for drug registration files, and import permit application files for drugs without circulation registration certificates (hereinafter referred to as expert sub-committees) based on its assigned functions and tasks. The structure of these expert sub-committees must be appropriate to the classification of registered products and registration forms or products applying for import permits and the form of such applications.

2. Expert reviewers shall operate according to the principle that all review opinions must be legally grounded, scientifically sound, and recorded in the minutes of the drug registration file review or the import permit application file review for drugs without circulation registration certificates. Expert reviewers are responsible to the Director of the Drug Administration Department for the contents of their reviews and recommendations related to the review of drug registration files, raw material for drug registration files, and import permit application files for drugs without circulation registration certificates.

3. Based on its assigned functions and tasks, the Drug Administration Department shall develop and promulgate regulations governing the organization and operation of expert groups reviewing drug registration files, raw material for drug registration files, and import permit application files for drugs without circulation registration certificates; sign contracts with expert reviewers or units participating in the organization of file reviews; organize training sessions and courses for expert reviewers; conduct evaluations of their professional capabilities and compliance with regulations to adjust and supplement expert reviewers as necessary.

4. The costs of organizing file reviews shall be implemented in accordance with the provisions of the law.

Chapter VII

IMPLEMENTING PROVISIONS

Article 46. Effective Date

1. This Circular takes effect from September 1, 2019.

2. Circular No. 44/2014/TT-BYT dated November 25, 2014, of the Minister of Health regarding drug registration becomes invalid from the date this Circular takes effect, except for the provisions concerning the registration of in vitro diagnostic products. 1. Registration files submitted before the date this Circular takes effect shall continue to be processed in accordance with Circular No. 44/2014/TT-BYT dated November 25, 2014, of the Minister of Health regarding drug registration, unless the registrant voluntarily implements the provisions from the date of issuance of this Circular.

Article 47. Transitional Provisions

2. Drugs and raw materials for drugs whose registration certificates expired between January 1, 2018, and June 30, 2020, may continue to maintain the validity of their registration certificates for an additional 12 months if they meet all the following conditions:

a) The drug does not fall under the cases temporarily suspending the acceptance of new or extended drug registration certificate applications as stipulated in Clause 2, Article 100 of Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government detailing certain provisions and measures to implement the Law on Medicines; Clause 54, Article 4 and Point a, Clause 53, 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 within the scope of management by the Ministry of Health;

b) There are no safety or efficacy warnings issued by the World Health Organization or the Vietnamese drug regulatory authority regarding the drug or raw material for drug;

c) The registrant submits a request to continue maintaining the validity of the registration certificate according to Form 6/TT attached to this Circular.

Within twenty days from receiving the request, the Drug Administration Department shall issue a written response.

3. During the validity period of the old registration certificate, if the registrant obtains an extension of a new registration certificate, the old registration certificate will remain valid concurrently with the new registration certificate for six months from the date the new registration certificate takes effect.

4. Original brand names already announced by the Drug Administration Department prior to the effective date of this Circular shall continue to be recognized. Registrants shall update the classification of original brand names according to Appendix II attached to this Circular during the validity period of the drug registration certificate.

4. Original brand-name drugs announced by the Drug Administration prior to the effective date of this Circular shall continue to be recognized. The registration entity shall update the classification of original brand-name drugs in accordance with Appendix II attached hereto within the validity period of the drug circulation registration certificate.

Article 48. Implementation Timeline

1. The deadline for registering excipients and capsule shells shall be implemented in accordance with the provisions of Clause 8, Article 143 of Decree No. 54/2017/NĐ-CP dated May 8, 2017, detailing certain articles and measures to implement the Law on Medicines.

2. The deadline for registering semi-finished herbal products shall be implemented in accordance with the provisions of Point c, Clause 78, Article 5, Chapter II of Decree No. 155/2018/NĐ-CP dated November 12, 2018, amending and supplementing certain regulations related to investment and business conditions under the management of the Ministry of Health.

3. For applications for extension, change, or supplementation of drug registration certificates submitted before January 1, 2020: It is not required that the Common Technical Document (CTD) must contain complete information about finished product standards; active substance and herbal material standards; name and address of the production facility for active substances and herbal materials.

4. For applications for raw materials in the form of semi-finished herbal products, excipients, capsule shells, and excipient raw materials, herbal materials, and semi-finished herbal products included in drug registration applications submitted before January 1, 2021: It is not required to submit legal documents as stipulated in Clause 11, Article 24 of this Circular.

Article 49. Reference Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 50. Responsibility for Implementation

1. The Drug Administration Department, based on its assigned functions and tasks and the ASEAN harmonization timeline for drug registration, shall be responsible for:

a) Organize and implement the provisions of this Circular;

b) Updating the list of drugs and raw materials for drugs granted or extended registration certificates within five days from the date of issuance or extension of the registration certificate, and other registration information on the Drug Administration Department's electronic information website;

c) Updating the list of drugs with proven bioequivalence within five days from the date of issuance of the registration certificate, and changes and supplements to such drugs within seven days from the date of approval of changes and supplements to the registration certificate on the Drug Administration Department's electronic information website;

d) Updating the list of original brand names within five days from the date of issuance of the registration certificate, and changes and supplements to original brand names within seven days from the date of approval of changes and supplements to the registration certificate on the Drug Administration Department's electronic information website;

đ) Reviewing and examining original brand-name drugs when there is evidence that the original brand-name drug no longer meets the criteria as prescribed;

e) Developing and promulgating standard operating procedures (SOPs) and a guidebook for drug registration (QM) for implementation in drug registration;

g) Cooperating with the Traditional Medicine Management Department in extending, changing, or supplementing registration certificates for traditional medicine and herbal materials according to Circular No. 44/2014/TT-BYT dated November 25, 2014, on drug registration issued by the Minister of Health;

In cases where the registrant engages in fraudulent behavior or arbitrarily modifies registration files, documents, or legal papers of Vietnamese or foreign authorities; uses fake seals or forges signatures or stamps of the registrant, manufacturer, or related entities in the registration files, the Drug Administration Department will issue a warning letter to the entity and cease accepting applications for issuing or extending registration certificates for drugs and raw materials in accordance with Clauses 2, 3, and 4, Article 100 of Decree No. 54/2007/NĐ-CP dated May 8, 2017, detailing certain articles and measures to implement the Law on Medicines.

In addition to the above forms, the Drug Administration Department will publicly disclose the violations of the entity on its electronic information website, and simultaneously notify the Inspection Agency and relevant competent authorities to consider and handle according to the law;

i) When necessary, the Drug Administration Department will organize meetings with the registrants, manufacturers, and assessors to clarify issues related to the assessment of drug and raw material registration files;

k) Announce on the Drug Administration Department's electronic information website the list of registrants and manufacturers of drugs and raw materials in accordance with Clauses 11 and 15, Article 23 of this Circular;

l) Develop regulations and implementation timelines for printing barcodes, QR codes, and DataMatrix Codes (DMC) on the outer packaging of drugs and raw materials to manage, identify, and trace the origin of drugs and raw materials circulating in the market, and submit them to the Minister of Health for promulgation;

m) Within thirty days from the date of issuance or extension of the registration certificate for drugs and raw materials, the Drug Administration Department will return the labels and instructions for use of the drugs to the registrant;

n) Within fifteen days from the date of issuance or extension of the registration certificate for drugs and raw materials, and seven days from the date of approval of changes and supplements to the registration certificate for drugs and raw materials, the Drug Administration Department will announce the source of raw materials for drugs produced in Vietnam on its electronic information website.

2. Provincial Departments of Health under the central government are responsible for inspecting and supervising the implementation of this Circular by pharmaceutical production and trading units within their jurisdiction.

3. Units under the Ministry of Health, Vietnam Pharmaceutical Corporation, and drug trading entities are responsible for implementing this Circular.

During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals should reflect them to the Ministry of Health (Drug Administration Department) for consideration and resolution./.