What is the validity period of the Certificates of eligibility for pharmacy business in Vietnam?

What is the validity period of the Certificates of eligibility for pharmacy business in Vietnam?

Pursuant to Article 41 of the Law on Pharmcacy in 2016 stipulating management of Certificates of eligibility for pharmacy business:

Management of Certificates of eligibility for pharmacy business

1. A Certificate of eligibility for pharmacy business does not have an expiry date.

2. The Government shall elaborate the following contents:

a) Applications and procedures for issuance, reissuance, adjustment, revocation of Certificates of eligibility for pharmacy business;

b) Areas and scope of business of dispensaries of hospitals and medical stations of communes;

c) Roadmap for pharmacy business establishment to fulfill Good Practice requirements.

As regulated above, a Certificate of eligibility for pharmacy business does not have an expiry date.

What is the validity period of the Certificates of eligibility for pharmacy business in Vietnam? Which agencies have the auhtority to issue Certificates of eligibility for pharmacy business to drug retailers in Vietnam? - image from internet

Which agencies have the auhtority to issue Certificates of eligibility for pharmacy business to drug retailers in Vietnam?

Pursuant to Articles 32 and 37 of the Law on Pharmcacy in 2016 stipulating the power to issue, reissue, adjust, revoke Certificates of eligibility for pharmacy business:

(1) The Minister of Health shall issue, reissue, adjust, revoke Certificates of eligibility for pharmacy business of the following pharmacy business establishments:

- Manufacturers of drugs/medicinal ingredients;

- Exporters, importers of drugs/medicinal ingredients;

- Providers of drug/medicinal ingredient storage services;

- Providers of drug/medicinal ingredient testing services;

- Providers of clinical trial services;

- Providers of bioequivalence study services.

(2) Directors of Provincial Departments of Health shall issue, reissue, adjust, revoke Certificates of eligibility for pharmacy business of the following pharmacy business establishments:

- Wholesalers of drugs/medicinal ingredients;

- Drug retailers, including drugstores, dispensaries of hospitals and medical stations of communes, retailers of herbal ingredients, herbal drugs, traditional drugs.

Which pharmacy establishments are not required to obtain a Certificate of eligibility for pharmacy business in Vietnam?

Pursuant to Article 35 of the Law on Pharmcacy in 2016 stipulating pharmacy establishments that are not required to obtain a Certificate of eligibility for pharmacy business:

Pharmacy establishments not required to obtain Certificates of eligibility for pharmacy business

1. Pharmacy establishments that are not required to obtain a Certificate of eligibility for pharmacy business include:

a) Every non-commercial pharmacy establishment;

b) Any business establishment that has a drug cabinet;

c) Herb farming establishments;

d) Any military health facility supplying drugs in ethnic minority areas, highlands, islands, or extremely disadvantaged areas.

2. Conditions to be satisfied by the establishments specified in Clause 1 of this Article:

a) The establishments mentioned in Point a Clause 1 of this Article shall satisfy the conditions specified in Clause 1 Article 33 hereof;

b) The establishments mentioned in Point b Clause 1 of this Article must be registered, satisfy storage conditions written on drug labels, the person in charge of which must have at least a basic diploma in pharmacy, and may only sell drugs on the List of permissible cabinet drugs promulgated by the Minister of Health;

c) Herb farming establishments shall fulfill Good Farming Practice requirements;

d) The establishments mentioned in Point d Clause 1 of this Article must satisfy storage conditions written on drug labels, the person in charge of which must have at least a basic diploma in pharmacy.

3. The Minister of Health shall elaborate this Article.

As regulated above, pharmacy establishments that are not required to obtain a Certificate of eligibility for pharmacy business include:

- Every non-commercial pharmacy establishment;

- Any business establishment that has a drug cabinet;

- Herb farming establishments;

- Any military health facility supplying drugs in ethnic minority areas, highlands, islands, or extremely disadvantaged areas.

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