Pharmacy establishments that are not required to obtain a Certificate of eligibility for pharmacy business in Vietnam

Pharmacy establishments that are not required to obtain a Certificate of eligibility for pharmacy business in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

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

According to Clause 1, Article 35 of the Law on Pharmacy 2016, 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.

2. Conditions of pharmacy establishments that are not required to obtain a Certificate of eligibility for pharmacy business in Vietnam

According to Clause 2, Article 35 of the Law on Pharmacy 2016, conditions of pharmacy establishments that are not required to obtain a Certificate of eligibility for pharmacy business in Vietnam include:

- The establishments mentioned in Point a Clause 1 of Article 35 of the Law on Pharmacy 2016 shall satisfy the conditions specified in Clause 1 Article 33 of the Law on Pharmacy 2016;

+ Every manufacturer of drugs/medicinal ingredients must have the premises, factory, laboratory, storage of drugs/medicinal ingredients, auxiliary systems, equipment, machinery for manufacture, testing, storage of drugs, quality control system, technical documents and personnel that fulfill GMP requirements;

+ Every importer and exporter of drugs/medicinal ingredients, provider of drug/medicinal ingredient storage services must have the premises, drug storage, storage equipment, transportation, quality control system, technical documents and personnel that fulfill Good Storage Practice requirements;

+ Every wholesaler of drugs/medicinal ingredients have the premises, drug storage, storage equipment, transportation, quality control system, technical documents and personnel that fulfill Good Distribution Practice requirements;

+ Every drug retailer must have the premises, a storage area, storage equipment, technical documents and personnel that fulfill Good Retailing Practice requirements; Retailers of herbal ingredients, herbal drugs, traditional drugs shall comply with Point b Clause 2 Article 69 of the Law on Pharmacy 2016;

+ Every provider of drug/medicinal ingredient testing services must have the premises, a chemical/microbiological/biological laboratory, auxiliary systems, testing equipment, chemicals, reagents, quality control system, technical documents and personnel that fulfill Good Laboratory Practice requirements;

+ Every provider of clinical trial services must have the premises, a clinical laboratory, testing laboratory, bio-chemical testing equipment, quality control system, technical documents and personnel that fulfill Good Clinical Practice requirements;

+ Every provider of bioequivalence services must have the premises, a laboratory for biological fluid analysis, equipment for biological fluid analysis, an area for drug users to stay and undergo bioequivalence assessment, quality control system, technical documents and personnel that fulfill Good Laboratory Practice requirements in the biological fluid analysis stage and fulfill Good Clinical Practice requirements in the clinical trial stage.

Where a provider of bioequivalence study service only fulfills Good Laboratory Practice requirements in biological fluid analysis, it must sign a contract or cooperate with a provider of clinical trial services that fulfills Good Clinical Practice requirements to carry out clinical trial in the process of bioequivalence study.

- The establishments mentioned in Point b Clause 1 of Article 35 of the Law on Pharmacy 2016 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;

- Herb farming establishments shall fulfill Good Farming Practice requirements;

- The establishments mentioned in Point d Clause 1 of Article 35 of the Law on Pharmacy 2016 must satisfy storage conditions written on drug labels, the person in charge of which must have at least a basic diploma in pharmacy.

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