The equivalent certificate of GMP Certificate for imported dietary supplements in Vietnam

The equivalent certificate of GMP Certificate for imported dietary supplements in Vietnam

Certificate of Good Manufacturing Practice (GMP) or equivalent certificate in case imported dietary supplements are applicable from July 1, 2019 in Vietnam.
Regulations on the application of GMP and the certification equivalent to the GMP Certificate for imported dietary supplements are guided in Article 4 of Circular No. 18/2019/TT-BYT dated July 17, 2019 of Health Ministry of Vietnam.

1. Imported dietary supplements must be produced at a establishment approved by a competent authority of the producing country (including a state management agency in charge of food safety or an organization authorized by a competent authority designated, recognized by the food safety state or an agency or organization of another country recognized by the state management agency of the producing country) issues one of the following certificates:

a) Certificate of Good Manufacturing Practice (GMP) for establishments producing dietary supplements;

b) A certificate or assessment of satisfaction of Good Manufacturing Practice for herbal drugs and traditional drugs with dosage forms corresponding to the dosage forms of imported dietary supplements for:
- Production facilities in countries announced by the Ministry of Health in the list of countries with which Vietnam has signed international treaties on mutual recognition of good manufacturing practice inspection results;
- Manufacturers in member countries of the   International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), Australia and approved by one of the US Food and Drug Administration - USFDA, countries of EU, European Medicines Agency - EMA, Australia (Therapeutic Goods Administration - TGA), Japan (Pharmaceuticals and Medical Devices Agency - PMDA) or Canada (Health Canada) inspected, assessed to meet Good Manufacturing Practice;
- Other manufacturing facilities have been announced by the Drug Administration of Vietnam - Ministry of Health, Administration of Traditional Medicine and Pharmacy - Ministry of Health to meet good manufacturing practices.

c) For countries or territories that do not to issue certificates specified at Points a and b of this Clause, the certification must be made in writing or published on the official website of the competent authority in that country or territory about the establishment”s satisfaction of requirements and production conditions for health supplements or herbal medicines or traditional drugs;

d) For countries or territories that do not issue certificates or certifications according to the provisions of Points a, b and c of this Clause, the Ministry of Health is responsible for setting up an expert council consisting of the following members: the following sections: leaders of Food Safety Department - Ministry of Health; representative of Drug Administration of Vietnam - Ministry of Health; representative of the Administration of Traditional Medicine and Pharmacy - Ministry of Health; representative of Legal Department - Ministry of Health; representatives of the Department of International Cooperation - Ministry of Health and experts in the appropriate field of expertise in case of necessity.

The expert council is responsible for reviewing and evaluating the conformity of the information in the documents provided by the enterprise with the principles and regulations of good manufacturing practice (GMP) of dietary supplements  specified in Clause 1 of  Article 3 of Circular No. 18/2019/TT-BYT to submit to the Leaders of the Ministry of Health for decision. In case equivalence is not recognized, a written reply must be given clearly stating the reason.

2. The requirements for the contents of the certificate or certificate of equivalence specified at Points a, b and c, Clause 1 of this Article include the following information:
a) Name of the competent agency or organization;
b) Date of issue;
c) Validity period (in case the certificate does not indicate the validity period, there must be documents proving that the production establishment still maintains food safety conditions: assessment report or periodic inspection report);
d) Full name and signature of the grantor;
dd) Name and address of the establishment granted;
e) Scope of certification;
g) Dosage form or certified product name.

Lawyer Vietnam Law Firm- Vietnamese Lawyers