What documents are included in the application for initial issuance of Certificate of eligibility for pharmacy business in Vietnam?

What documents are included in the application for initial issuance of Certificate of eligibility for pharmacy business in Vietnam?

Pursuant to Article 38 of the Law on Pharmacy in 2016 stipulating application for issuance, reissuance, adjustment of Certificate of eligibility for pharmacy business:

Application for issuance, reissuance, adjustment of Certificate of eligibility for pharmacy business

1. An application for the Certificate of eligibility for pharmacy business in the cases mentioned in Point a and Point c Clause 1 Article 36 hereof consists of:

a) An application form for issuance of the Certificate of eligibility for pharmacy business;

b) Corresponding technical documents of the pharmacy business establishment specified in Clause 2 Article 32 hereof;

c) A certified true copy of the certificate of enterprise registration or legal documents proving the existence of the establishment;

d) A certified true copy of the pharmacy practice certificate.

2. An application for the Certificate of eligibility for pharmacy business in the cases mentioned in Point b Clause 1 Article 36 hereof consists of:

a) An application form for issuance of the Certificate of eligibility for pharmacy business;

b) Technical documents corresponding to the changes;

c) A certified true copy of the certificate of enterprise registration or legal documents proving the existence of the establishment;

d) A certified true copy of the pharmacy practice certificate.

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As regulated above, the application for initial issuance of Certificate of eligibility for pharmacy business in Vietnam includes:

- An application form for issuance of the Certificate of eligibility for pharmacy business;

- Corresponding technical documents of the pharmacy business establishment;

- A certified true copy of the certificate of enterprise registration or legal documents proving the existence of the establishment;

- A certified true copy of the pharmacy practice certificate.

What documents are included in the application for initial issuance of Certificate of eligibility for pharmacy business in Vietnam? - image from internet

What are pharmacy business activities in Vietnam?

Pursuant to Article 32 of the Law on Pharmacy in 2016 stipulating pharmacy business activities and pharmacy business establishments:

Pharmacy business activities and pharmacy business establishments

1. Business activities include:

a) Trading in drugs/medicinal ingredients;

d) Provision of drug/medicinal ingredient storage services;

c) Provision of drug/medicinal ingredient testing services;

d) Provision of clinical trial services;

dd) Provision of bioequivalence study services.

2. Pharmacy business establishments include:

a) Manufacturers of drugs/medicinal ingredients;

b) Exporters, importers of drugs/medicinal ingredients;

c) Providers of drug/medicinal ingredient storage services;

d) Wholesalers of drugs/medicinal ingredients;

dd) Drug retailers, including drugstores, dispensaries of hospitals and medical stations of communes, retailers of herbal ingredients, herbal drugs, traditional drugs;

e) Providers of drug/medicinal ingredient testing services;

g) Providers of clinical trial services;

h) Providers of bioequivalence study services.

As regulated above, business activities include:

- Trading in drugs/medicinal ingredients;

- Provision of drug/medicinal ingredient storage services;

- Provision of drug/medicinal ingredient testing services;

- Provision of clinical trial services;

- Provision of bioequivalence study services.

Are business establishments that have drug cabinets required to obtain Certificates of eligibility for pharmacy business in Vietnam?

Pursuant to Article 35 of the Law on Pharmacy in 2016 stipulating pharmacy establishments not required to obtain Certificates 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, business establishments that have drug cabinets are not required to obtain Certificates of eligibility for pharmacy business in Vietnam.