What are regulations on language, presentation and legality of application for issuance, extension or adjustment of a certificate of traditional drug/herbal material marketing authorization in Vietnam?

What are regulations on language, presentation and legality of application for issuance, extension or adjustment of a certificate of traditional drug/herbal material marketing authorization in Vietnam?

Pursuant to Clause 1, 2 and 5, Article 4 of the Circular 21/2018/TT-BYT (amended by Clause 4 and 5, Article 1 of the Circular 39/2021/TT-BYT) stipulating language, presentation and legality of application for issuance, extension or adjustment of a certificate of traditional drug/herbal material marketing authorization in Vietnam as follows:

1. Language used in the application for issuance, extension or adjustment of a certificate of traditional drug/herbal material marketing authorization:

a) The application for marketing authorization of domestically manufactured traditional drug/herbal material must be made in Vietnamese language;

b) The application for marketing authorization of imported traditional drug/herbal material must be made in Vietnamese or English language. If made in English language, the package insert and summary of drug characteristics shall be written in Vietnamese language. Documents proving the safety and efficacy of the traditional drug must be enclosed with their copies written in the language of the country of origin and issued by a competent authority of the country of origin.

2. Regulations on preparation for application:

a) Submission of application in person or by post: The application must be prepared on A4 paper and firmly closed. The application shall have a cover page and a product information sheet that are arranged in the correct order of the table of contents and separated between sections. The separated parts shall be numbered and certified with a seal of the registration establishment or manufacturer in the whole of application. The quality standards, test methods, test sheets of traditional drugs and herbal ingredients shall be signed by the competent person and certified with a seal of the manufacturer.

b) Submission of application in person: The application for marketing authorization shall be prepared in word or pdf file, numbered in each section; arranged in the correct order of the table of contents. The quality standards, test methods, test sheets of traditional drugs and herbal ingredients shall be signed by the competent person and certified with a seal of the manufacturer.

5. Other documents:

a) The application form shall be signed by the head of the applicant or an authorized representative of the applicant and bear the seal (if any) of the applicant. Signature stamp must not be used;

b) In the case of authorization, the application shall include an original copy or certified true copy of the power of attorney issued by the applicant or representative office in Vietnam. To be specific:

- If the applicant authorized to apply for marketing authorization is not a manufacturer of traditional drug/herbal material and the foreign manufacturer of traditional drug/herbal material does not have a representative office in Vietnam, the power of attorney shall be prepared using the Form No. 09A enclosed with this Circular.

- If the representative office of the applicant for marketing authorization of traditional drug/herbal material is authorized to sign the marketing application, the power of attorney shall be prepared using the Form No. 09B enclosed with this Circular.

- If the brand owner that is not an applicant for marketing authorization of traditional drug/herbal material is authorized to use the name of the traditional drug/herbal material, the power of attorney shall be prepared using the Form No. 09C enclosed with this Circular.

c) If the registration establishment is not the manufacturer, the certificate of eligibility to trade herbal ingredients and traditional drugs of the registration establishment shall be a certified true copy or a copy certified with a seal of the manufacturer.

d) Certificates, protection certificates and contracts for assignment of industrial property rights in the application for drug marketing authorization (if any) that are granted or certified by industrial property authorities must be certified true copies or copies bearing stamp of the applicant.

Pursuant to Clause 7 Article 4 of the Circular 21/2018/TT-BYT (amended by Clause 4 and 5, Article 1 of the Circular 39/2021/TT-BYT) stipulating as follows:

7. Each traditional drug/herbal material must have a separate marketing application, except in the cases where the traditional drug (excluding the prepared traditional medicinal material) has the same formula for a dose unit and concentration but different package contents.

Pursuant to Article 5 of the Circular 21/2018/TT-BYT stipulating charges for marketing authorization of traditional drug/herbal material as follows:

The applicant for marketing authorization of traditional drug/herbal material shall pay charges as prescribed by the law on charges and fees.

What are regulations on language, presentation and legality of application for issuance, extension or adjustment of a certificate of traditional drug/herbal material marketing authorization for foreign enterprises in Vietnam?

Pursuant to Clause 6 Article 4 of the Circular 21/2018/TT-BYT (amended by Clause 6 and 7, Article 1 of the Circular 39/2021/TT-BYT) stipulating language, presentation and legality of application for issuance, extension or adjustment of a certificate of traditional drug/herbal material marketing authorization for foreign enterprises in Vietnam as follows:

6. Legal documents of a foreign enterprise must comply with the following regulations:

a) CPP; certificate of eligibility to produce and trade herbal ingredients and traditional drugs issued by the foreign competent state management agency; good manufacturing practices (GMP); license to establish representative office in Vietnam (hereinafter referred to as “legal documents”) shall be authentic copies or certified true copies:

- The authentic copy shall have signature, name of the signer and seal of the competent state management agency of the issuing country. The signature, name, title of signer and seal of the competent state agencies shall be consularly legalized in accordance with the law on consular legalization, except for the legal documents issued by the competent state management agencies of the issuing countries which have signed mutual legal assistance treaties with Vietnam;

- The certified true copy shall be certified by the competent agency or organization of Vietnam in accordance with the law of Vietnam on certification of copy from the original copy. The original copy shall be presented for the purpose of comparison (if necessary);

- If the issued legal document is an electronic document (including documents that fail to have enough signatures, names of the signer and seals of the competent state management agency of the issuing country), the registration establishment must submit one of the following additional documents:

If the legal document fails to have signature and seal of the competent state management agency that issues such document, it is not required to have the signature or seal of the competent state management agency in the document that proves the legal document in accordance with the law of the host country. The results of self-search for legal document from the official website of the agency competent that issues such document shall be certified with a seal and enclosed with the document that provides information on the link for search. The registration establishment shall be responsible to the law for the legality and accuracy of these documents, information and the results of self-search of the establishment.

The legal document shall be consularly legalized according to regulations (original copy or certified true copy).

- The legal documents in the application shall be valid at the time of receipt recorded on the Receipt Form. The legal documents shall be presented in English or Vietnamese. If the legal document is not presented in English or Vietnamese, the registration establishment shall provide the notarized translation in Vietnamese. If the CPP does not specify the validity period, the validity period shall be 24 months from the date of issuance.

b) The CPP shall satisfy regulations of point a of this Clause and the following regulations:

- The CPP shall be issued by the competent authority for management of drugs (according to the list of WHO on http://www.who.int), according to the form of the World Health Organization (WHO) applicable to the certification scheme on the quality of pharmaceutical products moving in international commerce.

- If the drug is produced by many different manufacturers, the CPP shall clearly state the name, address and role of each manufacturer;

- If the CPP fails to have information on the drug manufacturer that meets GMP, the registration establishment shall submit the GMP of all the manufacturers.

- The drug subject to circulation in the manufacturing country shall be certified. If the drug is not licensed to circulate in the manufacturing country or has been licensed without circulation in the manufacturing country, the registration establishment shall provide CPP which certifies that the drug has been circulated in reality in one of the countries.

- The information on the CPP shall be consistent with the relevant information in the application.

c) License for drug manufacturing and trading issued by the foreign competent authority must comply with regulations mentioned in Point a of this Clause and contain:

- Name and address of the issuing authority;

- Name and address of the drug-trading establishment;

- Scope;

- Effective period, which shall be written in the license and have to be unexpired when the application is submitted. In case the license does not have an expiration date, the foreign drug-trading establishment must provide the certificate indicating that it still operates in the pharmacy field when the application is submitted.

d) WHO GMP certificate, ISO or equivalent certificate must be granted by a competent authority of the country of origin and contain name and address of the manufacturer.

What are regulations on labels and instructional notes of traditional drug in Vietnam?

Pursuant to Clause 2 and 3, Article 4 of the Circular 21/2018/TT-BYT (amended by Clause 4 Article 1 of the Circular 39/2021/TT-BYT) stipulating labels and instructional notes of traditional drug in Vietnam as follows:

2. Regulations on preparation for application:

a) Submission of application in person or by post: The application must be prepared on A4 paper and firmly closed. The application shall have a cover page and a product information sheet that are arranged in the correct order of the table of contents and separated between sections. The separated parts shall be numbered and certified with a seal of the registration establishment or manufacturer in the whole of application. The quality standards, test methods, test sheets of traditional drugs and herbal ingredients shall be signed by the competent person and certified with a seal of the manufacturer.

b) Submission of application in person: The application for marketing authorization shall be prepared in word or pdf file, numbered in each section; arranged in the correct order of the table of contents. The quality standards, test methods, test sheets of traditional drugs and herbal ingredients shall be signed by the competent person and certified with a seal of the manufacturer.

3. There must be 02 (two) sample labels intended for each traditional drug/herbal material. Regarding imported traditional drug/herbal material, 01 (one) sample label is required in addition to the 02 aforementioned ones. These labels shall be attached on A4 pages bearing fan stamping of the applicant or the manufacturer. Upon receipt of the application for extension of the certificate of marketing authorization, the applicant shall only submit a copy of the approved sample label in case of no change to the original certificate.

What are regulations on Legal documents of the establishments which produce excipients, capsule shells, semi-finished herbal ingredients and herbal ingredients for the production of traditional drugs in Vietnam?

Pursuant to Clause 8 Article 1 of the Circular 39/2021/TT-BYT stipulating Legal documents of the establishments which produce excipients, capsule shells, semi-finished herbal ingredients and herbal ingredients for the production of traditional drugs in Vietnam as follows:

8. Legal documents of the establishments which produce excipients, capsule shells, semi-finished herbal ingredients and herbal ingredients for the production of traditional drugs may be one of the following types of documents:

a) GMP;

b) License for production which certifies that the manufacturer meets GMP;

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

d) CPP of excipient, capsule shell or semi-finished herbal ingredients (in case the CPP has information on GMP)

dd) Excipients in the application for marketing authorization of traditional drugs: If the documents specified in one of the points a, b, c, d of this Clause cannot be provided, the manufacturer of the finished or semi-finished drugs shall make self-assessment of the satisfaction of good manufacturing practices of the manufacturer of excipients according to regulations of 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 dated November 22, 2018 of the Minister of Health on good manufacturing practices for pharmaceutical products and pharmaceutical starting ingredients and self-declaration in the application for registration of traditional drugs on the principles and standards of good manufacturing practices that the excipient-manufacturing establishment meets and commits to take responsibility to law for this declaration according to Form 01/TT issued together with this Circular.

What are regulations on amendments to application for issuance of marketing authorization of traditional drugs and herbal ingredients in Vietnam?

Pursuant to Clause 9 Article 1 of the Circular 39/2021/TT-BYT stipulating regulations on amendments to application for issuance of marketing authorization of traditional drugs and herbal ingredients in Vietnam as follows:

9. General regulations on amendments to application for issuance of marketing authorization of traditional drugs and herbal ingredients

a) The time for amendments to application of the registration establishment shall not exceed 90 days from the date of receipt of the written request of the receiving agency. The time for amendments to application of the registration establishment shall fall outside the time limit for consideration of the application. In case of excess of 90 days, the application shall be invalid and the registration establishment shall re-implement the procedure for marketing authorization, except for cases in which it is required to have longer time to amend contents according to the written notification. To be specific:

- Test standards of the quality of finished products.

- Amend GMP/CPP or other legal documents.

- Add the new data on research on the stability according to request of the Director of the Traditional Medicine Administration of Vietnam;

If it is necessary to extend the time according to regulations, the registration establishment may extend the time for amendments to the application without excess of 120 days from the date of receipt of the written request for amendments of the receiving agency.

b) The registration establishment shall be only allowed to amend the same contents at most 02 times. If the registration establishment amends the contents in excess of the time according to regulations, the Traditional Medicine Administration of Vietnam will return the application to the registration establishment for the marketing authorization as the first time.

What are regulations on patents and security related to traditional drugs granted marketing authorization in Vietnam?

Pursuant to Article 6 of the Circular 21/2018/TT-BYT stipulating patents and security related to traditional drugs granted marketing authorization in Vietnam as follows:

The applicant for traditional drug marketing authorization that wishes to secure data about the application for marketing authorization of a new traditional drug as prescribed in the Circular No. 05/2010/TT-BYT dated March 01, 2010 of the Minister of Health shall specify its request for data security in the application form for issuance, extension or adjustment of the certificate of marketing authorization and provide legal documents concerning the protection of intellectual property rights (patent).

Best regards!