Procedures for declaration of compliance with EU-GMP standards in Vietnam for drug manufacturing facilities

Procedures for declaration of compliance with EU-GMP standards in Vietnam for drug manufacturing facilities in Vietnam (Internet image)

On January 9, 2023, the Ministry of Health issued Decision 49/QD-BYT on announcing replaced and abolished administrative procedures in the pharmaceutical sector within the scope of management functions of the Ministry of Health in Ho Chi Minh City. Circular 12/2022/TT-BYT.

Specifically, procedures for declaring compliance with EU-GMP standards for drug manufacturing facilities are prescribed as follows:

1. Compositions of application for declaration of compliance with EU-GMP standards in Vietnam

- Written notification of changes of applied GMP standards and inspection and assessment conducted by the stringent regulatory agency at the medical facility (Name of stringent regulatory agency, inspection time, contents/scope of inspection and results of inspection)

- Technical documents corresponding to the changes, GMP certificate/certificate of GMP compliance or GMP inspection report issued by the stringent regulatory agency;

2. Procedures for declaration of compliance with EU-GMP standards in Vietnam

The procedures for declaration of compliance with EU-GMP standards in Vietnam are as follows:

- Step 1: The manufacturer shall submit a written notification of changes according to attached form and technical documents corresponding to changes to the receiving authority

- Step 2: Within 05 days, the receiving agency shall publish the following information on the web portal of the Ministry of Health and the website of the receiving agency:

(Name of stringent regulatory agency, inspection time, contents/scope of inspection and results of inspection)

+ Name and address of the manufacturer;

+ Applied GMP standard;

+ Number of certificate and its validity period;

+ Name of stringent regulatory agency;

+ Contents/scope of inspection;

* Time limit for resolving procedures for declaring compliance with EU-GMP standards: 5 days from the date recorded on the application receipt form

* Agency carrying out procedures for declaring compliance with EU-GMP standards: Drug Administration/Traditional Medicine Administration

3. Form of carrying out the procedures for declaration of compliance with EU-GMP standards in Vietnam

Organizations implementing procedures for declaring compliance with EU-GMP standards can choose 1 of the following 3 methods to carry out procedures for declaring compliance with EU-GMP standards:

- In person at Reception Desk of the Ministry of Health;

- Online;

- By public postal service

* Legal basis for declaration procedures meeting EU-GMP standards

- Law on Pharmacy 2016.

- Decree No. 54/2017/ND-CP detailing a number of articles and measures to implement the Law on Pharmacy.

- Decree 155/2018/ND-CP on amendments to some articles related to business conditions under state management of the Ministry of Health.

- Circular 35/2018/TT-BYT regulating Good Manufacturing Practices for drugs and medicinal ingredients.

- Circular 12/2022/TT-BYT stipulating the amendments and supplements to a number of articles in Circular 35/2018/TT-BYT regulating Good Manufacturing Practices of drugs and medicinal ingredients;

More details can be found in Decision 49/QD-BYT takes effect from the date of signing.

Thanh Rin

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