Conditions for issuance of Certificate of eligibility for pharmacy business in Vietnam

Conditions for issuance of Certificate of eligibility for pharmacy business in Vietnam (Internet image)

1. What is the pharmacy business?

According to Clause 43, Article 2 of the Law on Pharmacy 2016, pharmacy business means one, some or all stages of the investment process, including inter alia manufacture, sale, provision of services related to drugs and medicinal ingredients on the market for with an aim to make a profit.

2. Conditions for issuance of Certificate of eligibility for pharmacy business in Vietnam

In order to be granted a Certificate of eligibility for pharmacy business, such business organization must meet the following infrastructure, equipment, and personnel conditions as prescribed 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 hereof;

- 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.

3. Types of pharmacy business establishments in Vietnam

Pharmacy business establishments in Vietnam include:

- Manufacturers of drugs/medicinal ingredients;

- Exporters, importers of drugs/medicinal ingredients;

- Providers of drug/medicinal ingredient storage services;

- 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;

- Providers of drug/medicinal ingredient testing services;

- Providers of clinical trial services;

- Providers of bioequivalence study services.

(Clause 2, Article 32 of the Law on Pharmacy 2016)

Thanh Rin

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