Chương I Thông tư 08/2022/TT-BYT: Quy định chung

Chapter I

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”);

g) Procedures for validation of marketing applications, renewal and revision thereof; Procedures for validation of applications for the license to import unapproved drugs.

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.

7. “medicinal material manufacturer” means the establishment that manufactures or releases the material(s) of the drug product.

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.

11. “semi-finished herbal ingredients” are medicinal materials derived from herbs in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly.

Article 3. Responsibilities of applicants

An applicant shall:
1. assume total legal responsibility for accuracy, legitimacy and truthfulness of every document included in the marketing application. cooperate with Vietnamese and foreign authorities and manufacturers in responding to inquiries of the Drug Administration of Vietnam regarding the authenticity of legal documents included in the marketing application.

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.

9. take responsibility for issues relevant to intellectual property rights of the drugs/medicinal materials registered in Vietnam.

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.

12. take responsibility in accordance with Clause 2 Article 57 of the Law on Pharmacy and provisions of this Article for the proposed drugs/medicinal materials from the day on which the Drug Administration of Vietnam signs the permission for change of the applicant, including the drugs/medicinal materials marketed before such permission is granted.

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).

5. Maintain the manufacturing facility’s satisfaction of operating conditions during the validity period of the marketing authorization.

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.

7. Update specifications of drugs/medicinal materials in accordance with the Circular No. 11/2018/TT-BYT and the Circular No. 38/2021/TT-BYT.

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.

Article 6. Language, format, quantity of documents

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;

c) Documents serving the GMP conformity assessment as prescribed in Article 95 and Article 98 of the Government's Decree No. 54/2017/ND-CP and Clause 53 Article 4, Clause 51 Article 5 of the Decree No. 155/2018/ND-CP, if a foreign drug/medicinal material manufacturer applies for the marketing authorization in Vietnam.

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;

b) For vaccines: 01 copy of each of the required documents; For other cases: 02 copies of each of the following documents: the application form, specifications, and test method;

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:

a) Quantity of required documents: 01 set of adequate documents as prescribed in this Circular (except covers). The documents that need to be kept confidential shall be submitted directly to the Drug Administration of Vietnam in accordance with the Circular No. 05/2010/TT-BYT dated March 01, 2010 of the Minister of Health of Vietnam;

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

1. The validity period of a marketing authorization is 05 years from the issuance date or renewal date, except for the case specified in Clause 2 of this Article.

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.

6. The quantity of marketing authorizations for drugs of the same manufacturer with the same active ingredients or herbal ingredients, dosage form, route of administration, content or concentration in a dosage unit: 01 marketing authorization of a trade name and 01 marketing authorization of an international nonproprietary name. This does not apply to drugs manufactured under processing contracts and drugs manufacture solely for export.

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

1. Criteria for classification of proprietary drugs and reference biologicals

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;

In case of any changes to the criteria in this Point or any other changes in the quality of the drug, they must be approved by the drug regulatory authority of the country of manufacture or a regulatory authority mentioned in Clause 9 Article 2 of this Circular that has granted marketing authorization of that drug or the applicant must provide data proving that the drug manufactured in Vietnam has equivalent quality with the proprietary drug or reference biological before the drug is processed or technology transfer is made.

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.

In case of any changes to the criteria in Point b Clause 1 of this Article or any other changes in the quality of the drug, they must be approved by the drug regulatory authority of the country of manufacture or a regulatory authority mentioned in Clause 9 Article 2 of this Circular that has granted marketing authorization of that drug or the applicant must provide data proving that the drug manufactured by the new manufacturer has equivalent quality with the proprietary drug or reference biological before the manufacturer is changed.

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:

- 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 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;

The applicant shall submit an application for update of classification of proprietary drug or reference biological in the said 03 cases as prescribed in Appendix II enclosed herewith.

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 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;

The applicant shall submit an application for update of classification of proprietary drug or reference biological in the said 03 cases as prescribed in Appendix II enclosed herewith.

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

Applicants that wish to keep the information in their marketing applications confidential shall follow instructions in the Circular No. 05/2010/TT-BYT and specify their request in Form No. 5/TT enclosed herewith.

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:

- Information on the CPP is found to have been erased or altered;

- 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:

a) Verification of authenticity of legal documents concerning consular legalization: The Drug Administration of Vietnam shall cooperate with the Consular Department affiliated to the Ministry of Foreign Affairs of Vietnam or Vietnamese diplomatic missions performing consular legalization tasks in foreign countries to verify the competence and information concerning the consular legalization of foreign legal documents for use in Vietnam in the cases specified in Paragraphs 2, 3 Point a and Point b Clause 1 of this Article;

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.

4. The verification of authenticity of the legal documents specified in Clause 1 of this Article shall be simultaneous with validation of the marketing application and within the time limit specified in Clause 5 Article 56 of the Law on Pharmacy. The marketing authorization shall be granted after obtaining satisfactory verification results from competent authorities mentioned in Clause 3 of this Article.

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.