Circular 08/2022/TT-BYT marketing authorization of drugs and medicinal materials

• Official number: 08/2022/TT-BYT
• Legislation Type: Circular
• Organization: The Ministry of Health
• Signer: Do Xuan Tuyen
• Issued Date: 05/09/2022

MINISTRY OF HEALTH OF VIETNAM -------	SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom – Happiness ---------------
No.: 08/2022/TT-BYT	Hanoi, September 05, 2022

CIRCULAR

MARKETING AUTHORIZATION OF DRUGS AND MEDICINAL MATERIALS

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

Pursuant to the Government's Decree No. 54/2017/ND-CP dated May 08, 2017 on elaboration of the Law on Pharmacy;

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

Pursuant to the Government's Decree No. 155/2018/ND-CP dated November 12, 2018 amending some regulations on conditions for doing business under management of the Ministry of Health;

At the request of the Director of the Drug Administration of Vietnam. 

The Minister of Health of Vietnam promulgates a Circular prescribing the marketing authorization of drugs and medicinal materials.

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GENERAL PROVISIONS

Article 1. Scope

1. This Circular provides for:

a) Documentation requirements, procedures for issuance, renewal, revision and revocation of the marketing authorization of modern medicines, vaccines, biologicals, herbal drugs and medicinal materials (including active ingredients, semi-finished herbal ingredients, excipients, and capsule shells) for human use in Vietnam;

b) Required clinical data for assurance of safety and efficacy in the application;

c) Requirements for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo Stage 4 clinical trial;

d) Rules for validation of marketing authorization applications (hereinafter referred to as “marketing application”) for drugs/medicinal materials, renewal and revision thereof;

dd) Rules for validation of applications for license to import drugs that are yet to be approved for marketing authorization (hereinafter referred to as “unapproved drugs”) in the cases specified in Point a Clause 43 Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on business conditions under state management of the Ministry of Health of Vietnam (hereinafter referred to as “Decree No. 155/2018/ND-CP”);

e) Rules for organization and operation of Marketing Authorization Advisory Board (hereinafter referred to as “the Advisory Board”);

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2. This Circular does not apply to the cases mentioned in Clause 2 Article 54 of the Law on Pharmacy and semi-finished herbal ingredients produced by the same manufactuers of the drug products as prescribed in Point e Clause 1 Article 93 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on elaboration of the Law on Pharmacy (hereinafter referred to as “Decree No. 54/2017/ND-CP”), unless relevant organizations voluntarily apply the provisions of this Circular.

Article 2. Definitions

For the purpose of this Circular, the terms below are construed as follows:

1. ASEAN common technical dossier (ACTD) means a document providing guidance on the format of a registration application for drug products regarding ASEAN Common Technical Requirements (ACTR) which are specified in Appendix I hereof.

2. ICH-CTD means the common technical document provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

3. “major variations” are variations that may affect significantly and/or directly the aspects of quality, safety and efficacy of the drug, specified in Appendix II hereof.

4.”minor variations” are variations with minimal/no significant impact on the aspects of quality, safety and efficacy of the drug, specified in Appendix II hereof.

5. “applicant” means the establishment whose name is specified in the marketing application, or application for renewal or revision of marketing authorization.

6. “drug manufacturer” means the establishment that carries out one or some or all of the manufacturing processes or release of the batch of drug.

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8. “Certificate of pharmaceutical product (CPP)” means a certificate issued in the format recommended by WHO according to WHO’s Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.

9. European Medicines Agency (EMA) and Stringent Regulatory Authorities (SRA) are the following agencies:

a) European Medicines Agency (EMA);

b) Stringent Regulatory Authorities (SRA): drug regulatory authorities that are considered as SRAs by WHO. SRAs include:

- Members of ICH established before October 23, 2015, including: US-FDA, drug regulatory authorities of European Union, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Japan’s Pharmaceuticals Medical Devices Agency (PMDA);

- ICH observers established before October 23, 2015, including: European Free Trade Association (EFTA), Swissmedic and Health Canada;

- Regulatory authorities associated with ICH members through legally-binding, mutual recognition agreements made before October 23, 2015, including: Australia, Iceland, Liechtenstein and Norway.

10. “product license holder” or “marketing authorization holder” means the establishment that holds the marketing authorization of the drug written on the Certificate of pharmaceutical product (CPP) issued using WHO's format.

Article 3. Responsibilities of applicants

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2. apply for revision according to Clause 4 Article 27, Clause 3 Article 30, Clause 3 Article 32 and Article 38 of this Circular during the validity period of the marketing authorization.

3. take responsibility for any revision to the label or package insert which is made according to the update request of the Drug Administration of Vietnam during the validity period of the marketing authorization without having to submit an application for revision.

4. ensure quality, safety and efficacy of the drugs/medicinal materials as declared in the marketing application.

5. send a written notice to the Drug Administration of Vietnam within 30 days from the day on which the marketing authorization is revoked in any country on the world if the drugs/medicinal materials have been granted the marketing authorization in Vietnam which has not yet been expired. The reasons for such revocation must be also specified in the notice.

6. at the request of a competent authority, cooperate with the drug manufacturer in doing studies or providing additional information about the to-be-marketed drug when there is information or evidence about the safety and efficacy of the drug during the validity period of its marketing authorization.

7. cooperate with the drug manufacturer, importer and distributor in monitoring, collecting, consolidating and analyzing information, and sending a report to the National Centre of Drug Information and Adverse Reactions Monitoring (National DI & ADR Centre) on post-vaccination reactions and adverse reactions of the drug in accordance with Clause 5 Article 77 of the Law on Pharmacy, national pharmacovigilance guidelines issued by the Ministry of Health of Vietnam and relevant regulations. 

8. maintain its satisfaction of eligibility requirements for pharmacy business during the validity period of the marketing authorization. In cases it no longer satisfies eligibility requirements for pharmacy business, the applicant shall follow procedures for changing the applicant in accordance with Clause 4 Article 27, Clause 3 Article 30, Clause 3 Article 32 and Article 38 of this Circular within 30 days from its failure to satisfy eligibility requirements for pharmacy business.

10. cooperate with the manufacturer in updating specifications of drugs/medicinal materials in accordance with the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Minister of Health of Vietnam stipulating quality of drugs and medicinal materials (hereinafter referred to as “Circular No. 11/2018/TT-BYT”) and the Circular No. 38/2021/TT-BYT dated December 31, 2021 of stipulating quality of herbal ingredients, traditional ingredients and traditional drugs (hereinafter referred to as “Circular No. 38/2021/TT-BYT”).

11. implement the approved risk management plan included in the application for issuance or renewal of the marketing authorization of vaccines.

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13. cooperate with the manufacturer in provide one of the documents specified in Clause 11 Article 22 of this Circular to competent authorities as requested.

14. assume other responsibility as prescribed in this Circular and relevant regulations of law.

Article 4. Responsibilities of drug/medicinal material manufacturers

1. Manufacture the drugs/medicinal materials at the facility granted the manufacture license/certificate of eligibility for pharmacy business that allows manufacture of the drugs/medicinal materials by a competent authority.

2. Assume total legal responsibility for the accuracy, legitimacy and truthfulness of all documents about the drugs/medicinal materials provided for the applicant for the marketing authorization in Vietnam.

3. Cooperate with the applicant in:

a) implementation of the provisions of Clauses 2, 3 and 4 Article 3 of this Circular;

b) fulfillment of competent authorities’ request for inspection or evaluation of the manufacturing facility.

4. Submit a request for revocation of the marketing authorization in case the drug/medicinal material may affect users’ health in terms of their quality, safety or efficacy (using Form No. 1/TT enclosed herewith).

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6. If the applicant fails to satisfy eligibility requirements for operation according to the notification given by a competent authority, the manufacturer shall be allowed to follow procedures for changing the applicant within 30 days from the date of the notification.

8. Take responsibility for evaluation and assurance that the medicinal material manufacturing facility complies with good manufacturing practices for medicinal materials, retention and provision of one of the documents specified in Clause 11 Article 22 of this Article to competent authorities at their request.

Article 5. Reporting on monitoring and evaluation of safety and efficacy

1. Pharmacy business establishments and health facilities shall monitor, collect, consolidate and analyze information, and submit reports to competent authorities on post-vaccination reactions and adverse reactions of the drugs in accordance with Article 77 and Article 78 of the Law on Pharmacy, the national pharmacovigilance guidelines issued by the Ministry of Health of Vietnam and relevant regulations.

2. The applicants shall submit reports on safety and efficacy of the drugs specified in Clause 2 Article 8 of this Circular (using Form No. 2A/TT for drugs or Form No. 2B/TT for vaccines):

a) to the National DI & ADR Center on a periodical basis of every 06 months during the validity period of the marketing authorization; and

b) when applying for renewal of the marketing authorization with the Drug Administration of Vietnam.

3. Health facilities that use the drugs specified in Clause 2 Article 8 of this Circular shall submit reports on the use of drugs (using Form No. 2C/TT) to the National DI & ADR Center on a periodical basis of every 06 months during the validity period of the marketing authorization.

4. The National DI & ADR Center shall prepare and submit consolidated reports on a periodical basis of every 06 months to the Drug Administration of Vietnam.

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1. Language of documents included in the marketing application

All documents included in the marketing application shall be written in either Vietnamese or English language. The package insert and summary of product characteristics shall be written in Vietnamese language.

2. Documents included in the marketing application shall be A4-size papers and firmly bound. The application shall have covers (Form No. 3/TT) arranged in the order specified in the Table of Contents (Form No. 4/TT). Different sections are separated from each other. The sections shall be numbered and bear the applicant’s or drug/medicinal material manufacturer’s seal on the first page (for foreign drug, the seal of the representative office shall be acceptable). These provisions shall not apply to online applications.

The following documents shall be bound separately and enclosed with 01 application form:

a) Bioequivalence study documents;

b) Pre-clinical and clinical study documents;

3. Different drugs may be included in the same marketing application if they have the same following elements, including: drug name, dosage form, route of administration, specifications; manufacturer’s name and address, formula, content active ingredient per unit dose (for metered-dose solid drugs), content or concentration of active ingredient (for non-metered solid drugs, liquid drugs or semi-solid drugs); concentration or content of active ingredient and material of the primary package (for parenteral drugs).

4. Quantity of required documents included in the application for issuance or renewal of the marketing authorization:

a) For modern drugs, vaccines, biologicals: 01 set of adequate documents specified in Clauses 1, 2, 3, 5 Article 27 of this Circular; For herbal drugs and medicinal materials: the documents specified in Clauses 1, 2 Article 30, Clauses 1, 2 Article 32 of this Circular;

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c) 02 sets of samples of the label of the drug/medicinal material and the package insert bearing the seal of the applicant (or seal of the representative office for foreign drugs) or of the manufacturer. The labels shall be attached or presented on papers of appropriate size which shall not be smaller than A4 size. In case of online application, only 01 set of samples of the label and the package insert is required.

5. Quantity of required documents included in the application for revision of the marketing authorization:

a) For modern drugs, vaccines and biologicals: 01 set of adequate documents specified in Clause 4 Article 27 of this Circular; For herbal drugs and medicinal materials: the documents specified in Clause 3 Article 30 and Clause 3 Article 32 of this Circular. 

b) For revision to the label or package insert: 02 sets of samples of the label and the package insert bearing the seal of the applicant (or seal of the representative office for foreign drugs) or of the manufacturer. The labels shall be attached or presented on papers of appropriate size which shall not be smaller than A4 size. In case of online application, only 01 set of samples of the label and the package insert is required.

6. Provisions on online application:

b) The online application roadmap shall be announced by the Ministry of Health of Vietnam. Since all documents must be submitted online as prescribed, online applications shall be submitted according to Point a of this Clause. If physical documents are required for verification purpose, the Drug Administration of Vietnam shall give written notification thereof.

Article 7. Marketing authorization application fees

Applicants shall pay the fees for issuance of the marketing authorization of drugs/medicinal materials in accordance with applicable regulations of law on fees and charges.

Article 8. Validity periods, symbols of marketing authorization and deadline for renewal; quantity of marketing authorization of drugs having same active ingredients or herbal ingredients, dosage form, route of administration, content or concentration in a dosage unit

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2. The validity period of the marketing authorization of the following drugs is 03 years:

a) New drugs and vaccines that apply for the marketing authorization of the first time, reference biologicals and similar biologicals that apply for the marketing authorization in Vietnam for the first time;

b) Drugs having the same active ingredient(s), concentration, content or dosage form as those of a new drug which has not been granted a 05-year marketing authorization;

c) Cases in which extension of monitoring of safety and efficacy advised by the Advisory Board;

d) Any of the drugs mentioned in Points a, b, and c of this Clause if a report on their safety and efficacy is not submitted when applying for renewal of the marketing authorization because the drug has not been marketed in reality, or a report on their safety and efficacy has been submitted but the quantity of drug used, quantity of patients or use duration is insufficient according to the Advisory Board, or the health facility recommends extension of monitoring of the safety and efficacy of the drug;

3. Each drug and medicinal material that has been granted the marketing authorization in Vietnam will have a separate registration number with the format specified in Appendix VI hereof.

4. Renewal deadline: Within 12 months before the expiration date of the marketing authorization, an application for renewal must be submitted.

5. In case of changes to the documents in the application for renewal, after 12 months from the issuance date of the decision on renewal of the marketing authorization, its holder shall implement the changes that have been approved in the renewal application.

Article 9. Criteria for classification and cases in which proprietary drugs and reference biologicals are declared

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a) A drug which has been granted marketing authorization in Vietnam shall be classified as proprietary drug or reference biological when it meets all of the following criteria:

- The safety and efficacy data is sufficient as prescribed in Article 13 of this Circular;

With regard to a reference biological, quality, preclinical and clinical documents and data must be sufficient to prove that it is developed as a biological product other than a biosimilar product from the first stage;

- The drug has been granted the marketing authorization by one of the regulatory authorities mentioned in Clause 9 Article 2 of this Circular, except for new drugs that are manufactured in Vietnam.

b) In case a drug has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam, and the drug processing is conducted in Vietnam or one, some or all of its manufacturing processes are transferred to a manufacturer in Vietnam, the proprietary drug or reference biological and the drug products processed or manufactured in Vietnam must satisfy all of the following criteria:

- They have the same formula;

- The manufacturing processes are the same;

- The material quality specifications are the same;

- The drug product specifications are the same;

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c) In case of change of the manufacturer of a drug declared as a proprietary drug or reference biological, the drug granted the new marketing authorization of the new manufacturer will also be classified as a proprietary drug or reference biological if the applicant makes a written request and all of the following criteria are satisfied:

- The drug has been granted the marketing authorization by one of the regulatory authorities mentioned in Clause 9 Article 2 of this Circular;

- The drug satisfies all of the criteria specified in Point b Clause 1 of this Article.

2. Cases in which drugs are classified as proprietary drugs or reference biologicals:

a) The drug which has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam and has been wholly manufactured in the country of one of the regulatory authorities mentioned in Clause 9 Article 2 of this Circular shall continue to be classified as proprietary drug or reference biological in one of the following cases:

- The marketing authorization of the drug has not yet expired or has been renewed or revised in cases other than the one specified in Point b Clause 2 Article 55 of the Law on Pharmacy. The applicant shall not be required to submit an application for classification of proprietary drug or reference biological;

- The drug is granted a new marketing authorization in the form of re-registration as prescribed in the Circular No. 44/2014/TT-BYT dated November 25, 2014 of the Minister of Health of Vietnam prescribing registration of drugs (hereinafter referred to  as “Circular No. 44/2014/TT-BYT”) and has the same formula, manufacturing processes, quality specifications of materials and finished drug products with the declared proprietary drug or reference biological or has any changes in the said contents approved by the Drug Administration of Vietnam or its home country. The applicant shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed herewith;

- The drug manufacturer is changed and the drug has been granted a new marketing authorization according to Point c Clause 1 of this Article. The applicant shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed herewith.

b) The drug which has been manufactured in a foreign country and declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam, and has not been wholly manufactured in the country of one of the regulatory authorities mentioned in Clause 9 Article 2 of this Circular but has been granted the marketing authorization in the country of one of the regulatory authorities mentioned in Clause 9 Article 2 of this Circular shall continue to be classified as proprietary drug or reference biological in one of the following cases:

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- The drug is granted a new marketing authorization in the form of re-registration as prescribed in the Circular No. 44/2014/TT-BYT and has the same formula, manufacturing processes, quality specifications of materials and finished drug products with the declared proprietary drug or reference biological, or has any changes in the said contents approved by Vietnam’s regulatory authority or its home country;

- The drug manufacturer is changed and the drug has been granted a new marketing authorization according to Point c Clause 1 of this Article;

c) The drug which has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam and of which all manufacturing processes are carried out in Vietnam or one or some manufacturing processes are carried out in Vietnam and others are carried wholly in the country of one of regulatory authorities mentioned in Clause 9 Article 2 of this Circular shall continue to be classified as proprietary drug or reference biological in one of the following cases:

- The marketing authorization of the drug has not yet expired or has been renewed or revised in cases other than the one specified in Point b Clause 2 Article 55 of the Law on Pharmacy. The applicant shall not be required to submit an application for classification of proprietary drug or reference biological;

- The drug is granted a new marketing authorization in the form of re-registration as prescribed in the Circular No. 44/2014/TT-BYT and has the same formula, manufacturing processes, quality specifications of materials and finished drug products with the declared proprietary drug or reference biological, or has any changes in the said contents approved by Vietnam’s regulatory authority or its home country. The applicant shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed herewith;

- The drug manufacturer is changed and the drug has been granted a new marketing authorization according to Point c Clause 1 of this Article. The applicant shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed herewith.

d) The drug which has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam, has one or some manufacturing processes carried out in Vietnam and others not carried wholly in the country of one of regulatory authorities mentioned in Clause 9 Article 2 of this Circular but has been granted the marketing authorization in the country of one of the regulatory authorities mentioned in Clause 9 Article 2 of this Circular shall continue to be classified as proprietary drug or reference biological in one of the following cases:

- The marketing authorization of the drug has not yet expired or has been renewed or revised in cases other than the one specified in Point b Clause 2 Article 55 of the Law on Pharmacy;

- The drug manufacturer is changed and the drug has been granted a new marketing authorization according to Point c Clause 1 of this Article;

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dd) If the drug has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam, and wholly manufactured in the country of one of regulatory authorities mentioned in Clause 9 Article 2 of this Circular, and the drug processing is conducted in Vietnam or one, some or all of its manufacturing processes are transferred to a manufacturer in Vietnam, the drug which is processed or manufactured in Vietnam and granted a new marketing authorization shall continue to be classified as a proprietary drug or reference biological provided that it satisfies the criteria in Point b Clause 1 of this Article. The applicant that places processing order or transfers manufacturing processes to a manufacturer in Vietnam shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed herewith;

e) If the drug has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam, has not been wholly manufactured in the country of one of regulatory authorities mentioned in Clause 9 Article 2 of this Circular but has been granted the marketing authorization in the country of one of the regulatory authorities mentioned in Clause 9 Article 2 of this Circular, and the drug processing is conducted in Vietnam or one, some or all of its manufacturing processes are transferred to a manufacturer in Vietnam, the drug which is processed or manufactured in Vietnam and granted a new marketing authorization shall continue to be classified as a proprietary drug or reference biological provided that it satisfies the criteria in Point b Clause 1 of this Article. The applicant that places processing order or transfers manufacturing processes to a manufacturer in Vietnam shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed herewith;

g) The drug which has not yet been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam shall be classified as a proprietary drug or reference biological if it satisfies the criteria in Point b Clause 1 of this Article. The applicant shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed herewith.

Article 10. Criteria for classification of drugs having demonstrated bioequivalence

Drugs granted the marketing authorization in Vietnam shall be classified as drugs having demonstrated bioequivalence when their reports on bioequivalence studies meet the Ministry of Health of Vietnam’s regulations on drugs requiring bioequivalence testing and requirements for reports on bioequivalence studies included in application for marketing authorization in Vietnam.

Article 11. Confidentiality of information in marketing application

Article 12. Verification of legal documents

1. Before granting the marketing authorization, the Drug Administration of Vietnam shall verify the authenticity of legal documents included in the marketing application in the following cases:

a) Regarding CPP:

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- The CPP is included in the marketing application of a manufacturer or applicant that has incurred administrative penalties imposed by Vietnam’s competent authorities for provision of information on technical documents which are not based on research findings or the manufacturer’s actual production as published on the website of the Drug Administration of Vietnam. Verification of CPP shall be applied for 02 years after the suspension of applications for issuance or renewal of marketing authorization has expired;

- The drug covered by the CPP is the drug applying for marketing authorization of the first time in Vietnam of a manufacturer, unless the drug is manufactured by different manufacturers of which at least a manufacturer has drugs granted marketing authorization in Vietnam;

- The CPP is an electronic copy which is obtained from the English database or website of the issuing authority or a foreign competent authority but cannot be verified by accessing the website path specified in the application;

- The CPP does not bear the seal of the issuing authority; 

- The verification is request by the Advisory Board.

b) Regarding legal documents about the applicant/manufacturer: Legal documents of an applicant or manufacturer that applies for marketing authorization in Vietnam for the first time.

2. Regarding drugs granted the marketing authorization, the Drug Administration of Vietnam shall verify legal documents when it receives information, in the form of a written document or public affairs email or through the mass media, about the the licensing and marketing of drugs in the drug’s home country which needs to be verified or clarified, or information about the foreign applicant or manufacturer’s failure to satisfy operating conditions.

3. Verification of the authenticity of the CPP and legal documents included in the marketing application shall be carried out in the form of written document or public affairs email as follows:

b) Verification of authenticity of legal documents: The Drug Administration of Vietnam shall cooperate with issuing authorities to verify the information on such legal documents in the cases specified in Paragraphs 1, 4, 5, 6 Point a Clause 1 of this Article.

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The request for verification of legal documents shall be also sent to the applicant. Within 06 months from the verification procedures initiated by the Drug Administration of Vietnam, if no verification results are provided by competent authorities, the Drug Administration of Vietnam shall submit a report to the Advisory Board on verification of legal documents and request it to suspend the issuance of marketing authorization.

Chapter II

MANDATORY CLINICAL DATA FOR ASSURANCE OF SAFETY AND EFFICACY; CRITERIA FOR EXEMPTION FROM CLINICAL TRIAL OR CERTAIN STAGES THEREOF IN VIETNAM; DRUGS THAT HAVE TO UNDERGO STAGE 4 CLINICAL TRIAL IN VIETNAM

Article 13. Clinical data in an application for marketing authorization of a modern drug, vaccine or biological

1. Mandatory clinical data for safety and efficacy in an application for marketing authorization of a new modern drug, vaccine or biological.

a) Clinical studies of the drug and data in clinical documents shall be conformable with guidelines given by ICH, the Ministry of Health of Vietnam or other organizations recognized by Vietnam (international organizations to which Vietnam is a member, regulatory authorities specified in Clause 9 Article 2 of this Circular), except for the case specified in Clause 3 of this Article;

b) Clinical data (except similar biologicals of reference biologicals granted marketing authorization in Vietnam) shall be sufficient for analysis and justification of the safety and efficacy of the drug in Asian populations for extrapolating clinical data from Asian populations according to instructions in Point a of this Clause, or bridging study data according to ICH-E5 guideline for extrapolating clinical data from Asian populations;

d) If the vaccine has sufficient clinical data for its safety and efficacy as prescribed in Point a and Point b of this Clause but the requirement specified in Point d Clause 4 Article 22 of this Circular is not satisfied, it is required to have clinical data pertinent to safety and immunogenicity in the intended population in Vietnam before granting marketing authorization.

2. If the content or concentration, route of administration, dose, indications, or intended users of a modern drug or dosage form which might affect its biopharmaceutics is different from those of the proprietary drug granted the marketing authorization in Vietnam or those of a drug which has been granted the marketing authorization by one of the regulatory authorities in Clause 9 Article 2 of this Circular but of which the proprietary drug has not yet been granted the marketing authorization in Vietnam, it is required to have clinical data as prescribed in Points a, b Clause 1 and Clause 3 of this Article before granting marketing authorization.

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Article 14. Mandatory clinical data for safety and efficacy in application for marketing authorization of a drug with new combination of similar biologicals or active ingredients 

1. A drug with new combination of active ingredients shall have sufficient clinical data according to guidelines of US FDA, EMA or WHO for clinical development of fixed-dose combination drugs according to Appendix IV enclosed herewith.

2. Similar biologicals shall have sufficient clinical data according to the guidelines of the Ministry of Health of Vietnam or WHO for development of similar biologicals. Guidelines of US FDA or EMA and other guidelines which are developed based on the aforementioned guidelines are acceptable. Guidelines of WHO, US FDA, EMA are provided in Appendix IV enclosed herewith.

Article 15. Mandatory clinical data for safety and efficacy in application for marketing authorization of a new modern drug which is not a proprietary drug

1. If a drug that has been granted the marketing authorization in its home country is a prescription drug (except drugs manufactured in Vietnam) and at least a similar drug (with the same active ingredient, content, concentration thereof, dosage form and route of administration) has been granted the marketing authorization by one of the regulatory authorities specified in Clause 9 Article 2 of this Circular, the clinical data shall satisfy one of the following requirements:

a) The use of clinical data of the similar drug is permitted by its owner. The clinical data shall satisfy the requirements in Article 13 of this Circular;

2. If a drug is considered as OTC drug according to regulations of the home country (except drugs manufactured in Vietnam and the case specified in Clause 3 of this Article) and at least a similar drug (with the same active ingredient, content, concentration thereof, dosage form and route of administration) has been granted the marketing authorization by a foreign country, the clinical data shall satisfy one of the following requirements:

a) The use of clinical data of the similar drug is permitted by its owner. The clinical data shall satisfy the requirements in Article 13 of this Circular;

b) There is clinical data obtained from published researches and bioequivalence studies (unless the drug does not require bioequivalence test according to regulations of its home country).

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Article 16. Mandatory clinical data for drugs granted marketing authorization in Vietnam in case of changes in clinical data thereof

In case of changes to clinical data for a modern drug, vaccine, biological or herbal drug that has been granted marketing authorization in Vietnam, the applicant shall provide the additional clinical data in accordance with Appendix II enclosed herewith.

Article 17. Criteria for exemption of one or some stages of clinical trial of new modern drugs, vaccines, biologicals before marketing authorization

In one of the following cases, the Minister of Health of Vietnam is entitled to exempt one or several stages of clinical trial (including clinical data) of a drug that fails to meet the requirements in Article 13 of this Circular on the basis of opinions given by the Advisory Board:

2. The drug has been granted marketing authorization by at least one of the regulatory authorities specified in Clause 9 Article 2 of this Circular according to the reduced clinical documents they require.

3. The drug is meant to treat a rare or fatal disease.

4. Vaccines and biologicals manufactured in Vietnam through technology transfer of one, some or all of the manufacturing processes and the clinical data of vaccines and biologicals before technology transfer satisfies the requirements in Clause 1 Article 13 and Article 14 of this Circular.

Article 18. Mandatory clinical data in an application for marketing authorization a herbal drug

1. Mandatory clinical data for assurance of safety and efficacy in the application for marketing authorization of a new herbal drug

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b) Data extracted from the following documents is acceptable as clinical data for consideration of safety and efficacy of a herbal drug:

- The treatises about safety and efficacy of the drug mentioned in pharmacopoeias or drug formularies of Vietnam and other countries;

- Evaluations of safety and efficacy of the drug published on SCI (Science Citation Index) journals and clinical data collected from other medical publications;

- Evaluations of safety and efficacy in a national, ministerial or provincial research which has been accepted.

2. Clinical data is not required as prescribed in Clause 1 of this Article if the herbal drug satisfies one of the following requirements:

a) The drug has the same composition, content of herbal ingredients, indications and dosage form as those of another herbal drug which has been granted marketing authorization (even if it has expired), except traditional drugs the indications of which do not include any of the diseases on the list of diseases published by the Minister of Health of Vietnam according to Point b Clause 1 Article 89 of the Law on Pharmacy;

Article 19. Criteria for exemption of one or some stages of clinical trial of herbal drugs before marketing authorization

In one of the following cases, the Minister of Health of Vietnam is entitled to exempt one or several stages of clinical trial (including clinical data) of a herbal drug that fails to meet the requirements in Article 18 of this Circular on the basis of opinions given by the Advisory Board:

1. The drug is meant to serve urgent needs for national defense and security, epidemic control, disaster recovery and cannot be replaced by any other drug on the market.

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3. The drug is meant to treat a disease on the list of diseases published by the Minister of Health of Vietnam according to Point b Clause 1 Article 89 of the Law on Pharmacy but is not exempt from clinical trial as prescribed in Clause 3 Article 20 of this Circular.

4. The drug is new combination of herbal ingredients that have been used in Vietnam and its indications do not include any of the diseases on the list of diseases published by the Minister of Health of Vietnam according to Point b Clause 1 Article 89 of the Law on Pharmacy.

Article 20. Criteria for exemption of clinical trial in Vietnam before marketing authorization

1. A generic drug has the same active ingredients, content and concentration thereof, route of administration, uses, doses, indications, intended users and dosage form as those of another drug that has been granted marketing authorization.

2. A new drug (except vaccines), has been granted marketing authorization in at least another country and has sufficient clinical data about its safety and efficacy according to Article 13 and Article 18 of this Circular.

3. A herbal drug has been granted the marketing authorization before the effective date of the 2016 Law on Pharmacy and has indications which do not include any of the diseases on the list of diseases published by the Minister of Health of Vietnam.

4. A vaccine satisfies the requirements in Point d Clause 4 Article 22 of this Circular, all of the manufacturing processes of which are carried out in the country of one of the regulatory authorities specified in Clause 9 Article 2 of this Circular, and the clinical data for its safety and efficacy is sufficient according to Article 13 of this Circular.

Article 21. Criteria for State IV clinical trial in Vietnam

Chapter III

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Section 1. APPLICATION FOR ISSUANCE, RENEWAL, REVISION OF MARKETING AUTHORIZATION OF DRUGS/MEDICINAL MATERIALS

Article 22. Documents in application for issuance, renewal, revision of marketing authorization of drugs/medicinal materials

1. Documents issued by foreign competent authorities shall bear consular legalization in accordance with regulations of law on consular legalization, except for the cases in which consular legalization is exempted by law.

2. Licenses, certificates, confirmations, registration certificates (hereinafter referred to as “legal documents”) that have effective dates written thereon must be effective on the date of receipt of the application (according to the receipt note). In case the CPP does not specify the effective period, it will be 24 months from the issuance date.

3. Legal documents:

a) Original copies shall bear signatures and names of the signers and seals of competent authorities of the certifying country; certified true copies shall be authenticated by Vietnamese competent authorities or organizations in accordance with Vietnam’s regulations of law on document authentication. Original copies shall be presented for verification purposes where necessary;

b) In case a legal document is an electronic document, which does not have to bear the signature and name of the signer or seal of the competent authority of the certifying country, the applicant shall submit one of the following documents:

- The original copy or certified true copy of the legal document which has been certified by the foreign competent authority and bears consular legalization as per regulations;

- The legal document search result from a website or English database of the issuing authority or competent authority of the foreign country which bear the applicant's seal enclosed with the document providing information about the search link. This shall be sent to the Drug Administration of Vietnam. The applicant shall bear legal responsibility for the legitimacy and accuracy of these documents, information and search result.

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a) The CPP must be issued by a competent authority and contains sufficient information according to the model certificate published on WHO's website (https://www.who.int).

b) The CPP shall bear the signature and name of the signer, and seal of the issuing authority. In case the CPP does not bear the seal of the competent authority of the certifying country, the applicant shall provide documents proving that the CPP does not have to bear the seal according to the certifying country's regulations.

c) For generic drugs, herbal drugs and probiotics, and drugs whose marketing authorization is renewed or revised:

If the drug has not yet been granted the marketing authorization in the country of origin or has been granted the marketing authorization but has not been marketed in reality in the country of origin, the applicant shall provide 01 legal document which is issued by the regulatory authorities prescribed in Clause 9 Article 2 of this Circular which certifies that the drug has been granted the marketing authorization and marketed in reality in such country and contains the following mandatory information: name of drug, active ingredients, concentration or content of active ingredients, dosage form, name and address of the manufacturer.

d) Regarding new modern medicines, vaccines, biologicals that are imported, except probiotics:

There has to be 01 CPP issued by the competent authority of the manufacturing country certifying that the drug is granted marketing authorization and marketed in reality in such country.

In case the issuing authority is one of the regulatory authorities specified in Clause 9 Article 2 of this Circular, only 01 CPP has to be submitted.

In case the issuing authority is not one of the regulatory authorities specified in Clause 9 Article 2 of this Circular, the applicant shall provide legal documents issued by the regulatory authorities prescribed in Clause 9 Article 2 of this Circular certifying that the drug has been granted the marketing authorization and marketed in reality in such country and contains the following mandatory information: name of drug, active ingredients, concentration or content of active ingredients, dosage form, name and address of the manufacturer, or documents proving that the drug in on WHO's prequalified list of medicines.

dd) Regarding drugs applied for classification of proprietary drugs or reference biologicals

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In case the issuing authority is one of the regulatory authorities specified in Clause 9 Article 2 of this Circular, only 01 CPP has to be submitted.

In case the issuing authority is not one of the regulatory authorities specified in Clause 9 Article 2 of this Circular, the applicant shall provide legal documents issued by the regulatory authorities prescribed in Clause 9 Article 2 of this Circular certifying that the drug has been granted the marketing authorization and marketed in reality in such country and contains the following mandatory information: name of drug, active ingredients, concentration or content of active ingredients, dosage form, name and address of the manufacturer.

e) In case an imported drug, vaccine or biological does not have a CPP that satisfies the requirements specified in Point c and Point d of this Clause, the Minister of Health of Vietnam, on the basis of opinions provided by the Advisory Board, shall make the decision if the drug/vaccine/biological has been granted the marketing authorization by at least one regulatory authority in any country and satisfies any of the following requirements:

- The drug/vaccine/biological is meant to serve national defense and security, epidemic control, disaster recovery or a state-level health program;

- In other cases under a mutual recognition agreement between competent authorities in terms of conditions for manufacturing and marketing of drugs, vaccines and biologicals.

g) The information displayed on the CPP must be consistent with relevant information in the marketing application. In case information on the CPP is not consistent with that in the marketing application, the applicant shall provide documentary explanation and evidence.

5. The application form and other administrative documents must bear signatures and seals. Signature seals are not permitted. Applicants and manufacturers may use digital signatures on their documents. The registration and use of digital signatures shall comply with the Government’s Decree No. 130/2018/ND-CP dated September 27, 2018. These documents shall be signed by one of the following persons:

a) The President of the Member Board or Board of Directors; the General Director, chief executive officer, or director of the applying or manufacturing establishment;

b) An assigned person according to the company's charter, authorization letter or other documents proving the authority of the signer;

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6. Regulations on authorization letter:

a) The document authorizing a person to act as the applicant shall have the following information:

- Name and address of the product license holder/marketing authorization holder or the authorizing manufacturer;

- Name and address of the authorized applicant;

- Name of the drug, concentration or content of active ingredients; dosage form;

- Authorization content.

In case the authorization involves multiple drugs, the authorization letter shall have a list of drugs with adequate information as mentioned above.

The authorization letter of a foreign applicant must bear consular legalization as per regulations. The authorization letter must be the original copy or an authenticated copy.

a) The document authorizing a person to sign the marketing application shall have the following information:

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- Names and positions of the authorizing person and authorized person;

- Name of the drug, concentration or content of active ingredients; dosage form;

- Authorization content.

- Effect of the authorization letter.

In case the authorization involves multiple drugs, the authorization letter shall have a list of drugs with adequate information as mentioned above.

The authorization letter shall be the original copy or a copy bearing the seal of the representative office (for foreign applicants) or the Vietnamese applicant.

c) Quantity of authorization letters in an application:

- In case the applicant is not the manufacturer, each application shall include one authorization letter bearing the name of the applicant;

- In case the position of the person who signs the application is not one of those specified in Point a and Point b Clause 5 of this Article, each application shall include one document authorizing that person to sign the application.

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8. The license to establish a representative office in Vietnam.

If the name or address of the applicant on the license to establish a representative office in Vietnam is different from those on the legal documents issued by foreign authorities, documentary evidence must be provided.

9. For foreign applicants: Legal documents issued by foreign authorities permitting at least one of the following: manufacture, wholesaling, export, import of drugs/medicinal materials.

In cases where the applicant is also the manufacturer written on the CPP, the legal documents mentioned in this Clause are not required.

In cases where the license for manufacture, wholesaling, export or import of drugs/medicinal materials is not issued in any country, it is required to have the business license for business registration certificate that permits manufacture, wholesaling, export or import of drugs/medicinal materials and a certification issued by a competent authority that the applicant is qualified and is operating in the pharmaceutical field, or a certificate of Good Manufacturing Practice, Good Distribution Practice, Good Supply Practice or Good Storage Practice.

In case of medicinal materials: if the home country does not grant licenses to traders of medicinal materials, other licenses available in the home country may be accepted if they permit manufacture, wholesaling, export or import of medicinal materials.

10. If the applicant is already included in the list of applicants for drugs/medicinal materials posted on the website of the Drug Administration of Vietnam, the documents mentioned in Clause 7, 8, 9 of this Article are not required.

a) The GMP certificate;

b) The manufacture license that certifies GMP compliance;

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d) The Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP);

dd) For excipients in marketing applications of drug products or semi-finished medicinal materials:

In case the documents specified in Point a, b or d of this Clause cannot be provided, the manufacturer of drug products or semi-finished drug shall carry out self-evaluation of GMP for excipients manufacturers according to regulations in Point dd Clause 1 Article 3, Point b Clause 3 Article 3 and Point dd Clause 5 Article 20 of Circular No. 35/2018/TT-BYT, which is amended by Points a, b, and dd Clause 6 Article 1 of Circular No. 29/2020/TT-BYT, include in the marketing application a self-declaration of GMP conformity, and take legal responsibility for such declaration according to Form No. 10/TT enclosed herewith;

e) For herbal ingredients in marketing applications:

In case the documents specified in Point a and Point b of this Clause cannot be provided, the applicant shall provide a certification of Good Agricultural and Collection Practice (GACP);

g) Other legal documents provided by competent authorities shall have the following mandatory information: name and address of the manufacturer, certification of GMP compliance and names of the active ingredients/excipients/capsule shells/semi-finished and finished herbal ingredients.

12. The label sample and package insert of the drug marketed in reality in the country of manufacture or the country in which the CPP is issued (certifying country) bearing the seal of the representative office, the applicant or the manufacturer (color prints are accepted if the colors thereon match those on the labels marketed in the home country. If the package insert of the drug marketed in the country of origin is not written in English, a Vietnamese translation bearing the seal of the representative office, applicant or manufacturer is required.

13. The label sample, the package insert of the drug to be marketed in Vietnam shall comply with regulations of the Minister of Health of Vietnam on labeling of drugs/medicinal materials and the following requirements:

a) The label sample and package insert shall bear the seal of the representative office, applicant or manufacturer;

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15. Specifications, test method, test report and stability study documents (for both active ingredients and drug product) shall be original copies bearing the seal of the manufacturer; in case there are multiple establishments participating in the manufacture of the product, the seal of the establish responsible for quality inspection of the drug or batch shall be accepted; copies shall bear the seal of the applicant (or representative office of the foreign applicant).

In case the application of an active ingredient does not bear the seal of its manufacture, the drug product manufacturer shall append its seal and take legal responsibility for the accuracy, legitimacy and truthfulness of this document.

The test report shall contain: name and address of the manufacturer, certificate number, name and signature of the responsible person, issuance date of the certificate), information about the drug/medicinal material (name, batch number, expiry date, applied standards, specifications, analysis result, conclusion on quality of the batch).

16. The test report, results of validation of specifications and test method in Vietnam:

For manufacturers that have not applied GMP under the roadmap of the Ministry of Health of Vietnam or those required by the Drug Administration of Vietnam according to Appendix III hereof, the test report, results of validation of specifications and test method in Vietnam shall be certified by a state-owned drug testing laboratory that satisfies GLP requirements or a profitable drug testing laboratory that has a certificate of eligibility (original copy or certified true copy).

17. The certificate that the medicinal material is permitted to be manufactured or marketed in the country of origin, on which the following information is mandatory: name of the ingredient, name and address of the manufacturer, the country of origin, signature and full name of the signer.

Article 23. Administrative documents in application for issuance, renewal, revision of marketing authorization of drugs/medicinal materials

1. Administrative documents in an application for marketing authorization of a new modern drug, vaccine or biological consists of:

a) Form No. 5/TT enclosed herewith;

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d) The label sample, the package insert of the to-be-marketed drug.

dd) The Certificate of Eligibility for Pharmacy Business (for Vietnamese applicants);

e) Legal documents, the license to establish a representative office in Vietnam (for foreign applicants);

g) Summary of product properties for new modern drugs, vaccines and biologicals (Form No. 6/TT enclosed herewith);

h) Legal documents of the manufacturer of active ingredients, excipients, capsule shells, semi-finished and finished herbal ingredients;

i) The certificate of the testing laboratory in the cases specified in Clause 16 Article 22 of this Circular;

k) The risk management plan (for vaccines) according to Form No. 7/TT enclosed herewith;

l) The label sample and the package insert of the drug being marketed in reality in the country of origin or the country in which the CPP is issued (for foreign applicants);

m) The CPP (for foreign applicants);

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2. Administrative documents of the application for marketing authorization of generic drugs, herbal drugs, medicinal materials shall comply with regulations of Points a, b, c, d, dd, e, h, i, l, m, n Clause 1 of this Article (an application for marketing authorization of a medicinal material manufactured in a foreign country also requires the certificate that the medicinal material is approved for manufacture or marketing in such country).

3. Administrative documents of the application for renewal of marketing authorization modern drugs, vaccines, biologicals, herbal drugs, medicinal materials include those specified in Points a, c, dd, e, m, n Clause 1 of this Article and the following documents:

a) The document authorizing a person to act as applicant in case of change of applicant when the application is submitted;

b) The marketing report according to Form No. 8/TT enclosed herewith;

c) A copy of the marketing authorization granted in Vietnam;

d) The report on monitoring and evaluation of safety and efficacy of the drug according to Form No. 2/TT enclosed herewith if the renewal requires such a report according to Clause 2 Article 5 of this Circular;

dd) The certificate that the medicinal material is permitted to be manufactured or marketed in the country of origin (for medicinal materials that are manufactured in foreign countries).

5. Administrative documents of the application for marketing authorization following simplified validation procedures are those specified in Points a, b, c, d, dd, e, h, i, l, m Clause 1 of this Article.

Section 2. APPLICATION FOR ISSUANCE, RENEWAL, REVISION OF MARKETING AUTHORIZATION OF MODERN DRUGS, VACCINES AND BIOLOGICALS

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Quality documents shall comply with Part II – ACTD or 3-ICH-CTD and the following regulations:

1. For vaccines, antiserum, blood extracts and human plasma:

a) The batch release certificate issued by a competent authority of the country in which the CPP is issued or one of the regulatory authorities specified in Clause 9 Article 2 of this Circular;

b) The test report, specifications and test method certified by National Institute for Control of Vaccines and Biologicals (NICVB).

2. For rare drugs, drugs serving national defense and security, epidemic control, disaster recovery, and drugs serving special treatment:

a) Rare drugs for treatment of rare diseases: existing stability studies according to ASEAN or ICH guidelines;

b) Drugs serving national defense and security, epidemic control or disaster recovery:

Stability study data existing at the submission date shall be accepted for consideration of expiry date of the drug according to opinions given by the Advisory Board if the time period of stability study data fails to meet the minimum study period requirement laid down in ASEAN guidelines.

After obtaining the marketing authorization, the applicant shall continue submit stability study documents of finished product, until the minimum period of stability study is satisfied according to ASEAN guidelines, to the Drug Administration of Vietnam in the form of modification as prescribed in Appendix II enclosed herewith for considering and updating the expiry date as prescribed.

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Based on opinions given by the Advisory Board, the Drug Administration of Vietnam shall decide the expiry date of drug, including the batch of drugs manufactured, according to actual stability study data.

3. If the manufacturer uses medicinal materials that are have been granted marketing authorization in Vietnam:

a) Quality documents of the materials and the documents mentioned in Point h Clause 1 Article 23 of this Circular are not required in the application for marketing authorization of the drug product;

b) The applicant shall submit the following documents:

- 01 test report of the medicinal materials provided by the drug product manufacturer the specifications in which are equivalent to or higher than those of the medicinal material manufacturer. Where the drug product manufacturer is unable to inspect all specifications, it shall provide test reports of remaining indicators provided by state testing bodies or testing laboratories granted certificate of eligibility for pharmacy business;

- 01 test report of the medicinal materials provided by the medicinal material manufacturer.

4. For simplified validation procedures:

a) Documents about active ingredients:

- Names of the active ingredients (international nonproprietary names);

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- Specifications and method for testing of the active ingredients and semi-finished product that contain the active ingredients. If a Vietnam’s pharmacopoeia or a reference pharmacopoeia accepted by the Ministry of Health of Vietnam is applied, only the name of the pharmacopoeia is required;

- 01 test report of active ingredients and semi-finished products provided by the manufacturer thereof, and 01 test report of active ingredients and semi-finished products provided by the manufacturer of the drug product;

- For semi-finished active ingredients, the manufacturer shall provide their formula and manufacturing process.

b) Documents about the drug product:

- The description and composition shall comply with Part 1 of ACTD;

- Specifications and method for testing of the drug product. If Vietnam’s pharmacopoeia or a reference pharmacopoeia accepted by the Ministry of Health of Vietnam is applied, only the name of the pharmacopoeia is required;

- Manufacture of the drug product: batch formula, manufacturing process and process controls; control of critical steps and intermediates.

- Test report of drug product;

- Primary package: appearance, materials and specifications;

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c) Other quality documents shall comply with Part II of ACTD or 3-ICH-CTD and shall be retained by the applicant and manufacturer.

5. The documents mentioned in this Article shall:

- ACTD;

- Guideline for stability study;

- Guideline for manufacturing process validation;

- Guideline for analytical method validation;

- Guideline on bioavailability and bioequivalence study;

b) Documents that are prepared according to ICH-CTD and guidelines thereof are not required to be converted to the requirements in Point a of this Clause;

c) If the Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) is available: the active ingredient documents specified in Points a, b of this Clause may be replaced by the following documents:

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- Analytical data of the batch of active ingredients;

- If the time limit for re-inspecting quality of the active ingredients is not specified in CEP, the stability study data of the active ingredients shall be submitted.

Article 25. Pre-clinical documents in application for issuance, renewal or revision of marketing authorization of modern drugs, vaccines or biologicals

Pre-clinical documents shall comply with Part III or ACTD or 4-ICH-CTD.

Pre-clinical documents are not required for probiotics with origins, bacterial strain, concentration or content, indications, doses that are similar to biologicals licensed by one of the regulatory authorities specified in Clause 9 Article 2 of this Circular.

Article 26. Clinical documents in application for issuance, renewal or revision of marketing authorization of modern drugs, vaccines or biologicals

Clinical documents shall comply with Part IV or ACTD or 5-ICH-CTD.

Clinical documents are not required for probiotics with origins, bacterial strain, concentration or content, indications, doses that are similar to biologicals licensed by one of the regulatory authorities specified in Clause 9 Article 2 of this Circular.

Article 27. Application for issuance, renewal or revision of marketing authorization of modern drugs, vaccines or biologicals

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a) The administrative documents specified in Clause 1 Article 23 of this Circular.

b) The quality documents specified in Article 24 of this Circular;

c) The pre-clinical documents specified in Article 25 of this Circular;

d) The clinical documents specified in Article 26 of this Circular;

dd) For proprietary drugs or reference biologicals: the documents specified in Points a, b, c, d Clause 1 of this Article and Paragraph 2 Point a Clause 1 Article 9 of this Circular.

2. An application for issuance of marketing authorization of a generic drug consists of:

a) The administrative documents specified in Clause 2 Article 23 of this Circular;

b) The quality documents specified in Article 24 of this Circular.

a) The administrative documents specified in Clause 3 Article 23 of this Circular;

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If the applicant has submitted the new administrative documents before the renewal application, they are not required in the renewal application even if they are yet to be approved.

4. An application for revision of the marketing authorization consists of:

a) The administrative documents specified in Clause 4 Article 23 of this Circular;

b) Documents suitable for the major variations and minor variations specified in Appendix II enclosed herewith. For vaccines of the same manufacturer or product license holder or marketing authorization holder, the manufacturing location may be changed within or outside the country in which the marketing authorization is granted.

5. An application for marketing authorization following simplified procedures consists of:

a) The administrative documents specified in Clause 5 Article 23 of this Circular;

b) The quality documents specified in Point a and Point b Clause 4 Article 24 of this Circular.

Section 3. APPLICATION FOR ISSUANCE, RENEWAL, REVISION OF MARKETING AUTHORIZATION OF HERBAL DRUGS

Article 28. Quality documents in application for issuance, renewal or revision of marketing authorization of herbal drugs

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a) The manufacturing process (only applied to herbal ingredients): detailed and adequate description of the preparation and processing of herbal ingredients. For semi-finished herbal ingredients and bone glue, it is required to describe in details the manufacturing process thereof, except for those that have been granted marketing authorization;

b) Specifications and test method

- For herbal ingredients other than semi-finished herbal ingredients: follow instructions in Circular No. 38/2021/TT-BYT;

- Regulations on specifications and test methods for herbal ingredients other than semi-finished herbal ingredients specified in Circular No. 38/2021/TT-BYT shall also be applied to semi-finished herbal ingredients.

c) Test report of ingredients

- 01 test report of herbal ingredients provided by the manufacturer of the drug product. Where the drug product manufacturer is unable to inspect all specifications, it shall provide test reports of remaining indicators provided by state testing bodies or testing laboratories granted certificate of eligibility for pharmacy business;

2. Drug product

a) Manufacturing process

- Formula of a smallest packaging unit: name, content, concentration, weight, specifications of each ingredient in a smallest packaging unit. If the drug product is made of semi-finished herbal ingredients or bone glue, it is required to specify the ratio of herbal ingredients to total weight of semi-finished herbal ingredients or bone glue, the the ratio of bone glue or semi-finished herbal ingredients to the initial herbal ingredients and content (%) of the active ingredients or substances therein;

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- Manufacturing process diagram: present all stages in the manufacturing process, including the path of ingredients and its consistency with the manufacturing process description;

- Manufacturing process description: describes in details every step of the manufacturing process, including specifications thereof;

- Equipment list: names, specifications and uses of each equipment;

- Control of manufacturing process: Describe in details control criteria for each stage, including the criterion, specifications, control method, control frequency and sample size;

b) Specifications and test method

- Formula of a smallest packaging unit: name, content, concentration, weight, specifications of each ingredient in a smallest packaging unit. If the drug product is made of semi-finished herbal ingredients or bone glue, it is required to specify the ratio of herbal ingredients to total weight of semi-finished herbal ingredients or bone glue, the the ratio of bone glue or semi-finished herbal ingredients to the initial herbal ingredients and content (%) of the active ingredients or substances therein;

- Specifications of drug product: comply with the Circular No. 11/2018/TT-BYT;

c) The test report of drug product;

d) Specifications of packages: Describe in details the material, specifications, quality and test method;

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Article 29. Safety and efficacy documents in application for issuance, renewal or revision of marketing authorization of herbal drugs

1. Safety and efficacy documents of herbal drugs shall comply with regulations in Appendix V enclosed herewith, ACTD or ICH-CTD.

2. The documents specified in Point b Clause 1 Article 18 of this Circular (if any).

Article 30. Application for issuance, renewal, revision of marketing authorization of herbal drugs

1. An application for issuance of marketing authorization of a herbal drug consists of:

b) The quality documents specified in Article 28 of this Circular;

c) The safety and efficacy documents specified in Article 29 of this Circular;

2. An application for renewal of marketing authorization of a herbal drugs consists of:

a) The administrative documents specified in Clause 3 Article 23 of this Circular;

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If the applicant has submitted the new administrative documents before the renewal application, they are not required in the renewal application even if they are yet to be approved.

3. An application for revision of the marketing authorization of a generic drug consists of:

a) The administrative documents specified in Clause 4 Article 23 of this Circular;

b) Documents about major variations and minor variations according to Section D Appendix II enclosed herewith.

Section 4. APPLICATION FOR MARKETING APPLICATION OF MEDICINAL MATERIALS

Article 31. Quality documents in application for issuance, renewal or revision of marketing authorization of medicinal materials

1. For active ingredients: Documents of active ingredients specified in ACTD. Submit the Drug Master File if the manufacturer’s specifications are applied.

2. For semi-finished active ingredients: The same documents specified in ACTD as those of drug products, in which the documents about the drug product will be replaced with documents about the semi-finished products; the formula of a single dose or smallest packaging unit will be replaced with the batch formula.

3. For semi-finished herbal ingredients, excipients and capsule shells:

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b) Manufacturing process

- Manufacturing process description: describes in details every step of the manufacturing process, including specifications thereof;

- Equipment list: names, specifications and uses of each equipment;

- Control of manufacturing process: Describe in details control criteria for each stage, including the criterion, specifications, control method, control frequency and sample size.

c) Specifications and test method

- Regulations on specifications and test methods for herbal ingredients other than semi-finished herbal ingredients specified in Circular No. 38/2021/TT-BYT shall also be applied to semi-finished herbal ingredients;

- Specifications of excipients and capsule shells shall comply with Circular No. 11/2018/TT-BYT.

d) The test report;

dd) Specifications of packages: Describe in details the material, specifications, quality and test method;

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Article 32. Application for issuance, renewal, revision of marketing authorization of medicinal materials

1. An application for issuance of marketing authorization of a medicinal material consists of:

a) The administrative documents specified in Clause 2 Article 23 of this Circular;

b) The quality documents specified in Article 31 of this Circular.

2. An application for renewal of marketing authorization of a medicinal material consists of:

a) The administrative documents specified in Clause 3 Article 23 of this Circular;

b) Relevant documents according to Section B of Appendix II enclosed herewith if there are changes to the administrative documents of the medicinal material at the time of application for renewal of the marketing authorization (excluding changes in samples of the label).

If the applicant has submitted the new administrative documents before the renewal application, they are not required in the renewal application even if they are yet to be approved.

3. An application for revision of the marketing authorization of a medicinal material consists of:

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b) Documents about major variations and minor variations according to Section B Appendix II enclosed herewith.

Chapter IV

PROCEDURES FOR ISSUANCE, RENEWAL, REVISION OF MARKETING AUTHORIZATION OF DRUGS/MEDICINAL MATERIALS; PROCESSING OF APPLICATIONS FOR IMPORT OF DRUGS WITH MARKETING AUTHORIZATION

Article 33. Drugs eligible for quick and simplified validation

1. Drugs eligible for quick validation

a) A drug included in the list of rare drugs announced by the Minister of Health of Vietnam;

b) Drugs serving urgent needs for national defense and security, epidemic control or disaster recovery;

c) Domestic drugs that are manufactured by production lines that satisfy GMP, GMP-EU, GMP-PIC/S standards and equivalent standards within 18 months from the issuance date of the GMP certificate;

d) Vaccines that have been prequalified by WHO; vaccines used for national expanded immunization programs;

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- Antineoplastic drugs;

- Next-gen antiviral drugs;

- Next-gen antibiotics;

- Drugs for treatment of haemorrhagic fever, tuberculosis, malaria;

- Immunosuppresive drugs used in organ transplantation.

e) Drugs that can be domestically manufactured, including:

- Antineoplastic drugs, vaccines, biologicals, next-gen antiviral drugs, next-gen antibiotics, and immunosuppresive drugs used in organ transplantation that are manufactured in Vietnam under a processing agreement or technology transfers agreement;

- Herbal drugs under a national, ministerial or provincial research which has been accepted; drugs wholly obtained from domestic herbal ingredients that satisfy GACP standards;

- New domestic drugs that have undergone clinical trial in Vietnam;

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h) Proprietary drugs that are manufactured in Vietnam under a processing agreement or technology transfer agreement;

i) Drug whose manufacturer is changed resulting in application for issuance of a new marketing authorization as prescribed in Point b Clause 2 Article 55 of the Law on Pharmacy.

2. Drugs eligible for simplified validation procedures

A marketing application will be eligible for simplified validation procedures if all of the following conditions are satisfied:

a) The drug is manufactured in a factory that periodically undergoes GMP inspection by the Drug Administration of Vietnam;

b) The drug is included in the list of OTC drugs;

c) The dosage form of the drug is not modified-release;

d) The drug is not directly applied to the eye.

Article 34. Authority to approve issuance, renewal, revision of marketing authorization of drugs and medicinal materials

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2. The Drug Administration of Vietnam shall:

b) publish on its website the minor variations to the marketing authorization of drugs/medicinal materials that only require notification.

Article 35. General procedures for issuance, renewal, revision of marketing authorization of drugs/medicinal materials

1. Applications can be submitted online, in person or by post to the Drug Administration of Vietnam.

2. After receiving adequate documents, the Drug Administration of Vietnam shall issue the receipt note (using form No. 9/TT enclosed herewith) to the applicant.

The Drug Administration of Vietnam shall receive application without requesting the applicant to submit CPP in the case prescribed in Point e Clause 4 Article 22 of this Circular and the documents specified in Point b Clause 1 Article 24 of this Circular at the submission time.

3. Receipt of applications for import of unapproved drugs shall comply with the provisions of Point b Clause 1 Article 77 of Decree No. 54/2017/ND-CP.

4. Validation of applications for issuance, renewal, revision of the marketing authorization of drugs/medicinal materials and applications for import of unapproved drugs:

a) The Drug Administration of Vietnam shall send received applications to validators or units assigned by the Ministry of Health of Vietnam on the basis of the list of validators approved by the Drug Administration of Vietnam or validating units;

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c) The Drug Administration of Vietnam shall consult with the Advisory Board about its proposal as prescribed in Point b of this Clause in the following cases:

- Whether to grant, renew or approve the revision of the marketing authorization of drugs/medicinal materials, except for the cases specified in Clause 5 of this Article;

- Whether to declare the proprietary drug or reference biological, unless the applicant is not required to submit application for classification of proprietary drug or reference biological as prescribed in Article 9 of this Circular;

- Whether to grant the license to import an unapproved drug;

- Other cases proposed by the Drug Administration of Vietnam to serve urgent treatment.

Article 36. Procedures for granting marketing authorization of drugs and validation of applications for import of unapproved drugs

1. Within 12 months from the receipt of an adequate application for issuance of the marketing authorization (except the case specified in Article 39 of this Circular), the Drug Administration of Vietnam shall issue marketing authorization. If an application is rejected or yet to be approved, the Drug Administration of Vietnam shall respond in writing and provide explanation. Processing deadlines:

a) Within 02 months from the receipt of an application, the Drug Administration of Vietnam shall consider, classify and transfer it to the validator or validating unit. Within 06 months from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for making proposal in accordance with Clause 4 Article 35 of this Circular;

b) Within 02 months from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response if the application is rejected and provide explanation. If the Drug Administration of Vietnam makes the proposal or needs to obtain opinions from the Advisory Board about an application, it shall transfer the application to the Office of the Advisory Board for holding a meeting;

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d) Within 01 month from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board.

2. Within 36 months from the day on which the Drug Administration of Vietnam requests submission of additional pre-clinical and clinical documents, bioequivalence documents, or stability study documents (or 12 months for other documents), the applicant shall provide the additional documents as requested. Otherwise, the application will be rejected.

During the validation of the submitted application, the applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug or legal documents about the applicant, the drug or medicinal material manufacturer.

3. Within 06 months from the receipt of adequate additional documents, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application is satisfactory, or give written response to rejected application according to the conclusions given by the Advisory Board, or give written response and provide explanation for the application yet to be approved. Processing deadlines:

a) Within 01 month from the receipt of an application, the Drug Administration of Vietnam shall consider, classify and transfer it to the validator or validating unit. Within 02 months from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for making proposal in accordance with Clause 4 Article 35 of this Circular;

b) Within 01 month from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response and provide explanation for the rejected application. If the Drug Administration of Vietnam makes the proposal or needs to obtain opinions from the Advisory Board about an application, it shall transfer the application to the Office of the Advisory Board for holding a meeting;

c) Within 01 month from the receipt of documents from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 01 month from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board.

4. Validation of applications for import of unapproved drugs:

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b) Within 20 days from the receipt of the validation record:

- The Drug Administration of Vietnam shall consolidate opinions from the validators or validating units and consider relevant information to decide whether to propose the grant of the import license.

- If an application needs to be submitted to the Advisory Board as prescribed in Point c Clause 4 Article 35 of this Circular, the Drug Administration of Vietnam shall submit it in the next meeting;

- If an application is unsatisfactory, the Drug Administration of Vietnam shall send written response and provide explanation.

c) Within 05 working days from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall grant the import license if the application is satisfactory, or give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board;

d) After receiving the modified application from the applicant, the Drug Administration of Vietnam shall follow instructions in Points a, b and c of this Clause.

If the Advisory Board requests modification of the application without resubmission of the application, the Drug Administration of Vietnam shall inform the applicant and, if the modified application is satisfactory, grant the license without resubmitting to the Advisory Board.

Article 37. Procedures for renewal of marketing authorization of drugs/medicinal materials

1. Within 03 months from the receipt of an adequate application, the Drug Administration of Vietnam shall renew the marketing authorization of drug/medicinal material. If the renewal application is rejected or yet to be approved, the Drug Administration of Vietnam shall give a written response and provide explanation. Processing deadlines:

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b) Within 12 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response and provide explanation for the rejected application. If the Drug Administration of Vietnam makes the proposal or needs to obtain opinions from the Advisory Board about an application, it shall transfer the application to the Office of the Advisory Board for holding a meeting;

d) Within 18 working days from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall issue a decision to renew the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board.

2. The applicant shall provide additional documents within 12 months from the day on which it receives a request from the Drug Administration of Vietnam. Otherwise, the application will be rejected.

During the validation of the submitted application, the applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug or legal documents about the applicant, the drug or medicinal material manufacturer.

The time limit prescribed in Clause 5 Article 56 of the Law on Pharmacy shall exclude the period from the date on which the Drug Administration of Vietnam issues the request for additional documents to the date on which additional documents are submitted.

3. Within 03 months from the receipt of adequate additional documents, the Drug Administration of Vietnam shall issue a decision to renew the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board.

Additional documents shall be examined in accordance with the provisions of Clause 1 of this Article.

Article 38. Procedures for revision of unexpired marketing authorization of drugs/medicinal materials

1. Revision of the marketing authorization of drug/medicinal material, except for the cases specified in Clause 2 of this Article

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a) Within 08 working days from the receipt of an adequate application, the Drug Administration of Vietnam shall consider, classify and transfer it to the validator or validating unit. Within 01 month from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for consideration in accordance with Clause 4 Article 35 of this Circular;

c) Within 06 working days from the receipt of the application from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 18 working days from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall declare the proprietary drug, reference biological or drug with demonstrated bioequivalence, approve revised contents or give written response and provide explanation for the application which is rejected or yet to be approved according to conclusions given by the Advisory Board.

2. Minor variations that only require notification:

Within 15 working days from the receipt of an adequate application, the Drug Administration of Vietnam shall classify and publish minor variations that only require notification on its website. If revised contents can not be classified as minor variations that only require notification, the Drug Administration of Vietnam shall give a written notification.

The applicant shall make and assume the full responsibility for revised contents from the date of the application receipt note. The applicant/drug manufacturer shall assume legal responsibility for the accuracy and truthfulness of minor variations that only require notification, and retain relevant documents to serve competent authorities’ post-sale inspection.

3. Within 36 months from the day on which the Drug Administration of Vietnam requests submission of additional pre-clinical and clinical documents, bioequivalence documents or stability study documents (or 12 months for other documents), the applicant shall provide the additional documents as requested. Otherwise, the application will be rejected.

During the validation of the submitted application, the applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug or legal documents about the applicant, the drug or medicinal material manufacturer.

The time limit prescribed in Clause 5 Article 56 of the Law on Pharmacy shall exclude the period from the date on which the Drug Administration of Vietnam issues the request for additional documents to the date on which additional documents are submitted.

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b) Within 07 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response and provide explanation for the application which is rejected or yet to be approved. If an application is satisfactory or requires opinions from the Advisory Board, the Drug Administration of Vietnam shall transfer it to the Office of the Advisory Board for holding a meeting;

c) Within 06 working days from the receipt of documents from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 18 working days from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall declare the proprietary drug, reference biological or drug with demonstrated bioequivalence; approve the revision if the application is satisfactory. The Drug Administration of Vietnam shall send written response and provide explanation for the application which is rejected or yet to be approved according to conclusions given by the Advisory Board.

5. The implementation of the revisions to the marketing authorization must be completed within 12 months from the day on which the Drug Administration of Vietnam gives approval for such revisions.

6. The applicant or drug manufacturer shall update the label and package insert of the drug without submitting a revision application or sending notification to the Drug Administration of Vietnam in the following cases:

a) The label or package insert is provided in accordance with Clause 2 Article 35 of the Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health of Vietnam;

b) The label or package insert is revised according to the Official Dispatch given by the Drug Administration of Vietnam to instruct the implementation of guidelines of the Advisory Board;

d) Other contents:

- Change to information position or information about the importer on the label or package insert;

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- Change in the order of information on the package insert without change to information thereof which has been approved;

- Addition of specifications to the label or package insert approved by the Drug Administration of Vietnam;

- Removal of information other than the compulsory one on the label or package insert.

Article 39. Issuance of marketing authorization of drugs following quick and simplified validation procedures and grant of marketing authorization of medicinal materials

1. Within 06 months from the receipt of an adequate application, the Drug Administration of Vietnam shall grant the marketing authorization of drugs/medicinal materials. If an application is rejected or yet to be approved, the Drug Administration of Vietnam shall a written response and provide explanation. Processing deadlines:

a) Within 16 working days from the receipt of an adequate application, the Drug Administration of Vietnam shall classify and transfer it to the validator or validating unit. Within 03 months from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for consideration in accordance with Clause 4 Article 35 of this Circular;

b) Within 18 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response and provide explanation for the application which is yet to be approved. If an application is satisfactory or unsatisfactory or requires opinions from the Advisory Board, the Drug Administration of Vietnam shall transfer it to the Office of the Advisory Board for holding a meeting;

c) Within 10 working days from the receipt of documents from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

2. Within 36 months from the day on which the Drug Administration of Vietnam requests submission of additional pre-clinical and clinical documents, bioequivalence documents or stability study documents (or 12 months for other documents), the applicant shall provide the additional documents as requested. Otherwise, the application will be rejected.

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The time limit prescribed in Clause 5 Article 56 of the Law on Pharmacy shall exclude the period from the date on which the Drug Administration of Vietnam issues the request for additional documents to the date on which additional documents are submitted.

3. Within 03 months from the receipt of adequate additional documents, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board. Processing deadlines:

a) Within 10 working days from the receipt of an application, the Drug Administration of Vietnam shall consider, classify and transfer it to the validator or validating unit. Within 16 working days from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for making proposal in accordance with Clause 4 Article 35 of this Circular;

b) Within 08 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response and provide explanation for the application which is yet to be approved. If the Drug Administration of Vietnam makes the proposal to approve or reject or needs to obtain opinions from the Advisory Board about an application, it shall transfer the application to the Office of the Advisory Board for holding a meeting;

c) Within 10 working days from the receipt of documents from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

Chapter V

REVOCATION OF MARKETING AUTHORIZATION, TEMPORARY REJECTION OF APPLICATIONS FOR ISSUANCE OR RENEWAL OF MARKETING AUTHORIZATION

Article 40. Authority and procedures for revocation of marketing authorization

1. Authority to revoke the marketing authorization and responsibility to inform the revocation:

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b) Provincial Departments of Health and health authorities affiliated to supervisory ministries shall take charge of notifying the revocation decisions issued by the Drug Administration of Vietnam in their provinces.

2. Procedures for revocation in the cases specified in Point a and Point b Clause 1 Article 58 of the Law on Pharmacy:

Within 30 days from the issuance date of the decision to recall a drug, the Drug Administration of Vietnam shall issue a decision to revoke the marketing authorization of the drug/medicinal material.

3. Procedures for revocation in the cases specified in Point d and Point dd Clause 1 Article 58 of the Law on Pharmacy

Within 30 days from the day on which a competent authority reaches the conclusion that documents in the marketing application is forged, or the drug/medicinal material is manufactured at a location other than the registered one, the Drug Administration of Vietnam shall issue a decision to revoke the marketing authorization of the drug/medicinal material.

4. Procedures for revocation in the cases specified in Point c and Point e Clause 1 Article 58 of the Law on Pharmacy

Within 10 days from the day on which a notification that the drug is not safe or effective on human is given by a Vietnamese competent authority or WHO or country of origin, or a foreign competent authority revokes the product certificate, the Drug Administration of Vietnam shall issue a decision to revoke the marketing authorization of the drug/medicinal material.

5. Procedures for revocation in the cases specified in Point g Clause 1 Article 58 of the Law on Pharmacy:

a) A written request for revocation of the marketing authorization (using Form 1/TT enclosed herewith) shall be submitted;

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Article 41. Temporary rejection of applications for issuance or renewal of marketing authorization

1. Applications for issuance or renewal of marketing authorization will be temporarily rejected in accordance with the provisions of Clauses 2, 3 and 4 Article 100 of the Decree No. 54/2017/ND-CP.

Chapter VI

RULES FOR ORGANIZATION AND OPERATION OF ADVISORY BOARD, VALIDATING UNITS AND VALIDATORS

Article 42. Organization and operation of Advisory Board

1. The Advisory Board is established by the Minister of Health of Vietnam. The Advisory Board is composed of experts whose qualifications and experience are appropriate for validating applications, questioning opinions of validators and proposals of the Drug Administration of Vietnam, and provide the Minister of Health with advice about pharmacy laws, safety and efficacy documents of drugs/medicinal materials.

2. The Advisory Board has the responsibility to provide the Minister of Health of Vietnam with advice on issuance, renewal, revision of marketing authorization; issuance of license to import unapproved drugs on the basis of validation conclusions given by validators and proposals of the Drug Administration of Vietnam, and relevant issues at the request of the Minister of Health of Vietnam. The Advisory Board shall assume responsibility before the Minister of Health of Vietnam for its advice and opinions.

3. Operation of the Advisory Board:

a) The Advisory Board operates following the rule of unanimity, democracy, objectivity and transparency. The Advisory Board shall give opinions on a scientific and lawful basis while taking account of validation conclusions given by validators, clinical reality and proposals of the Drug Administration of Vietnam;

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The chairperson or a person authorized by the chairperson to chair the meeting shall draw the conclusion when it is approved of by at least 2/3 of the participants. Dissenting opinions shall be reserved.

Opinions, including dissenting opinions, of the members and the conclusions drawn by the Advisory Board shall be written in the meeting minutes.

c) If a meeting is not held, the chairperson shall obtain written opinions from its members;

After the deadline for sending opinions, the chairperson or a person authorized by the chairperson shall reach conclusions when at least 2/3 of the members have sent their opinions.

The conclusions of the Advisory Board shall be reached based on consenting opinions of at least 2/3 of its members, the consolidated report and proposal of the Drug Administration of Vietnam;

d) Where necessary,  members of the Advisory Board are entitled to consider and validate the application, and the chairperson may seek opinions from independent experts other than its members reaching final conclusions. These experts may participate in the meeting of the Advisory Board or send their written opinions, have the same responsibilities and rights as those of the members of the Advisory Board;

dd) Conflict of interest rules must be complied.

4. The Drug Administration of Vietnam shall propose to the Minister of Health of Vietnam regulations on organization and operation of the Advisory Board, the mechanism for cooperation between the Advisory Board and validators regarding issuance, renewal and revision of marketing authorizations and licenses for import of unapproved drugs.

5. Operating budget of the Advisory Council shall comply with regulations of law.

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Article 43. Organization ad operation of validating units, validators of applications for issuance, renewal and revision of marketing authorization and applications for license to import unapproved drugs

1. The Drug Administration of Vietnam and validating units shall establish validating teams in charge of validating legal documents, specifications, pharmacology, clinical data, dosage form, stability, bioequivalence and list of experts of validating teams in charge of validating marketing applications and applications for license to import unapproved drugs. The composition of each validating team shall be suitable for the proposed products, registration form or licensing form.

2. Validators’ opinions shall be given on a lawful and scientific basis, and written in the validation record. Validators shall assume responsibility before the Director of the Drug Administration of Vietnam and validating units for their validation works and opinions about applications for issuance, renewal and revision of marketing authorization or applications for license to import unapproved drugs.

The Drug Administration of Vietnam and validating units shall provide training courses for validators; organize assessment of the validators’ knowledge and compliance with regulations of law, which is the basis for replacement or employment of validators.

4. Funding for validation shall be allocated in accordance with regulations of law.

Chapter VII

IMPLEMENTATION

Article 44. Effect

1. This Circular comes into force from October 20, 2022.

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a) The Circular No. 32/2018/TT-BYT dated November 12, 2018 of the Minister of Health of Vietnam;

b) Clause 3 Article 1 of the Circular No. 23/2021/TT-BYT dated December 09, 2021 of the Minister of Health of Vietnam;

c) Clause 5 Article 1 of the Circular No. 29/2020/TT-BYT dated December 31, 2020 of the Minister of Health of Vietnam;

d) Point h Clause 3 Article 14 of the Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health of Vietnam.

Article 45. Transition 

1. Applications which have been submitted before the effective date of this Circular shall be processed in accordance with regulations in force at the submission time, unless applicants wish to apply regulations of this Circular when it comes into force.

2. Applications which have been submitted before the effective date of this Circular and are currently under consideration may be processed in accordance with relevant regulations of this Circular or regulations in force before the effective date of this Circular whichever is favorable for applicants.

3. With regard to a drug for which the application for marketing authorization has been submitted in accordance with regulations in force before the effective date of the Circular No. 32/2018/TT-BYT and which has been granted the marketing authorization or has the marketing authorization renewed, drug products shall be only made of medicinal materials supplied by manufacturers that meet GMP requirements within an appropriate scope as prescribed in Article 141 of the Decree No. 54/2017/ND-CP. Manufacturer and applicant shall retain documentary evidences as prescribed in Clause 11 Article 22 of this Circular and present them to competent authorities as requested.

4. Applications for marketing authorization of Covid-19 vaccines to serve urgent demand shall comply with the provisions of the Circular No. 11/2021/TT-BYT dated August 19, 2021 of the Minister of Health of Vietnam.

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7. With regard to proprietary drugs declared by the Ministry of Health of Vietnam before the effective date of this Circular, the Drug Administration of Vietnam shall be assigned to modify or update information about such declared proprietary drugs at the request of applicants.

8. In case Appendixes I, III and IV enclosed herewith are updated according to Asean common technical requirements, within 06 months from the day on which updated technical documents are published on Asean website (https://asean.org/our-communities/economic-community/standard-and-comformance/key-documents-publications/), the Drug Administration of Vietnam shall organize translation and publish updated translations on both its website and the website of the Ministry of Health of Vietnam.

Within 06 months from the day on which updated translations are published on its website and the website of the Ministry of Health of Vietnam, applicants and manufacturers are required to update them in their applications.

9. Drugs manufactured in Vietnam under technology transfer agreements and drugs undergoing secondary packaging shall still be treated in accordance with the provisions of the Circular No. 32/2018/TT-BYT until the Circular prescribing marketing authorization of drugs manufactured in Vietnam under processing agreements or technology transfer agreements promulgated by the Ministry of Health of Vietnam comes into force.

Article 46. Implementation roadmap

1. Since this Circular comes into force, the manufacturer that has more than 02 drugs which have the same active ingredients or herbal ingredients, dosage form, administration route, content or concentration in a unit dose and which have been granted the marketing authorization shall, when applying for renewal of the marketing authorization, cooperate with the applicant to select and apply for renewal of the marketing authorization of 02 drugs as prescribed in Clause 6 Article 8 of this Circular; the marketing authorization of other drugs shall be renewed until December 31, 2025 inclusively.

3. Application of registration numbers using the structure specified in Appendix VI enclosed herewith when issuing or renewing marketing authorization shall start from January 01, 2023. When renewing the marketing authorization of drugs granted registration numbers before January 01, 2023, such registration numbers may continue to be used for a maximum duration of 12 months from the registration number issued using the structure specified in Appendix VI enclosed herewith.

Article 47. Reference clauses 

If any legislative documents or regulations referred to in this Circular are amended or superseded, the newest ones shall apply.

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1. The Drug Administration of Vietnam shall, within the ambit of its assigned functions and tasks, and pursuant to the roadmap for ASEAN harmonization of drug registration, take the responsibility to:

a) Implement and organize the implementation of this Circular;

b) Update on its website the list of drugs and medicinal materials whose marketing authorizations are granted or renewed within 05 days from the day on which the marketing authorization is granted or renewed, and other information about registration of drugs and medicinal materials;

c) Publish and update on its website the list of drugs with demonstrated bioequivalence, proprietary drugs and reference biologicals within 05 days from the issue date of the marketing authorization, and revisions to their information within 07 days from the day on which the revisions are approved;

d) Review drugs with demonstrated bioequivalence, and declared proprietary drugs and reference biologicals when they may no longer satisfy the set requirements;

dd) Develop, issue and organize implementation of SOPs in drug registration and QM;

e) Cooperate with the Traditional Medicine Administration of Vietnam in renewing and revising the marketing authorizations of traditional drugs and herbal ingredients that have been issued in accordance with the Circular No. 44/2014/TT-BYT dated November 25, 2014 of the Minister of Health of Vietnam;

Other than the abovementioned method, the Drug Administration of Vietnam will make an announcement about the violation on its website, inform inspection authorities and competent authorities for taking appropriate actions in accordance with regulations of law;

h) In cases where a drug manufacturer forges or falsifies legal documents of Vietnamese or foreign authorities, or provides an applicant with documents which are issued without referring to studies or actual manufacturing activities, the Drug Administration of Vietnam will issue a warning and stop receiving applications from such manufacturer in accordance with Clause 2 through 4 Article 100 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017.

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i) Where necessary, the Drug Administration of Vietnam may hold a meeting with the applicant, manufacturer or experts to clarify the issues that arise during validation of the applications;

k) Publish on its website the list of applicants and manufacturers of drugs and medicinal materials in accordance with Clause 10 and Clause 14 Article 22 of this Circular;

l) Propose to the Minister of Health of Vietnam regulations and a roadmap for use of bar codes, QR codes and DataMatrix codes (DMCs) on secondary packages of drugs and medicinal materials of manufacturers in order to serve management, identification and tracing of origin of marketed drugs and medicinal materials;

m) Return the label and package insert to the applicant within 30 days from the date of issue or renewal of the marketing authorization;

n) Publish on its website the origin of medicinal materials of domestically manufactured drugs within 15 days from the date of issue or renewal of the marketing authorization, or within 07 days from the day on which the revisions to the marketing authorization are approved.

2. Provincial Departments of Health shall carry out inspection of the implementation of this Circular by pharmaceutical manufacturers and sellers in their provinces.

3. Affiliated units of the Ministry of Health of Vietnam, Vinapharm and drug sellers have the responsibility for implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health of Vietnam (via the Drug Administration of Vietnam) for consideration./.

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PP. MINISTER
DEPUTY MINISTER




Do Xuan Tuyen