Procedure for the issuance of the certificate of eligibility for pharmacy business (Part 2)

1

Receiving authority

Drug Administration of Vietnam - Ministry of Health (“DAV”)

2

How to submit the dossier

An entity applying for a certificate of eligibility to conduct pharmacy business ("Entity") shall submit an application in one of the following forms:

• In person; or
• By mail.

3

Dossier composition

01 dossier includes:

General requirements documents:

1. An application for a Certificate of eligibility for pharmacy business in accordance with Form No. 19 of Appendix I in Appendix II of Decree No. 155/2018/ND-CP;
2. A certified copy of the Enterprise Registration Certificate or legal documents proving the establishment of the pharmaceutical company;
3. A certified copy of the Pharmacy Practice Certificate;
4. Original technical documents: Including the Good Pharmacy Practices Certificate at the business location (if any) and specific technical documents for each pharmaceutical company.

Specific technical documents for each pharmaceutical company:

• For facility manufacturing drugs/drug ingredients:

5. Documents on premises, factory, laboratory, warehouses for storage drugs/drug ingredients, auxiliary systems, equipment, machinery for manufacture, testing, storage of drugs, quality control system, technical documents and personnel according to the principle of Good Manufacturing Practice.
6. Technical documents and personnel according to the principle of Good Distribution Practice (in case of selling/delivering drugs/drug ingredients manufactured by the establishment to a wholesaler, retailer, medical examination and treatment establishment, except for delivery at the drug-manufacturing establishment's warehouse).

• Facility importing and exporting drugs/drug ingredients and facility providing of drugs/drug ingredients storage services:

5. Documents on premises, warehouses for storage drugs/drug ingredients, storage equipment, means of transportation, quality control system, technical documents and personnel according to the principle of Good Storage Practice.

4

Fees

VND 30,000,000

5

Result

Certificate of eligibility for pharmacy business

Facility manufacturing drugs/drug ingredients

Every facility manufacturing drugs/drug ingredients must have the premises, factory, laboratory, warehouses for storage drugs/drug ingredients, auxiliary systems, equipment, machinery for manufacture, testing, storage of drugs, quality control system, technical documents and personnel that fulfill Good Manufacturing Practice requirements.

The head of pharmacist of a facility manufacturing drugs/drug ingredients must have:

• For facility manufacturing drugs:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree);
3. At least 02 years of apprenticeship in a suitable pharmacy establishment.

• For facility manufacturing drug ingredients that are active ingredients, excipients, or capsule shells

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree) or a bachelor’s degree in chemistry;
3. At least 03 years of apprenticeship in a suitable pharmacy establishment.

• For facility manufacturing vaccines, biologicals, and ingredients thereof:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree) or a bachelor’s degree in general medicine or a bachelor's degree in biology;
3. At least 05 years of apprenticeship in a suitable pharmacy establishment.

• For facility manufacturing herbal ingredients:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree) or a bachelor’s degree in traditional medicine or traditional pharmacy;
3. At least 02 years of apprenticeship in a suitable pharmacy establishment.

The person in charge of quality assurance of a facility manufacturing drugs/drug ingredients must have:

• For facility manufacturing drugs:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree);
3. At least 05 years of apprenticeship at a drug-manufacturing facility or drug-testing facility.

• For facility manufacturing drug ingredients that are active ingredients, excipients, or capsule shells:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree) or a bachelor’s degree in chemistry;
3. At least 03 years of apprenticeship at a facility manufacturing drugs/drug ingredients or drug-testing facility.

• For facility manufacturing vaccines, biologicals, and ingredients thereof:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree) or a bachelor’s degree in general medicine or a bachelor's degree in biology;
3. At least 05 years of apprenticeship at a facility manufacturing or testing vaccines, biologicals.

• For facility manufacturing herbal ingredients:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree) or a bachelor’s degree in traditional medicine or traditional pharmacy;
3. At least 02 years of apprenticeship in a suitable pharmacy establishment.

Facility importing and exporting drugs/drug ingredients and facility providing of drugs/drug ingredients storage services

Facility importing and exporting drugs/drug ingredients and facility providing of drugs/drug ingredients storage services must have the premises, warehouses for storage drugs, storage equipment, means of transportation, quality control system, technical documents and personnel that fulfill Good Storage Practice requirements.

The head of pharmacist of a facility importing and exporting drugs/drug ingredients and facility providing of drugs/drug ingredients storage services must have:

• Facility importing and exporting drugs/drug ingredients:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree);
3. At least 02 years of apprenticeship in a suitable pharmacy establishment.

• Facility importing and exporting vaccines, biologicals:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree) or a bachelor’s degree in general medicine or a bachelor's degree in biology;
3. At least 02 years of apprenticeship in a suitable pharmacy establishment.

• Facility importing and exporting herbal ingredients, herbal drugs, traditional drugs:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree) or a bachelor’s degree in traditional medicine or traditional pharmacy;
3. At least 02 years of apprenticeship in a suitable pharmacy establishment.

• Facility providing of drugs/drug ingredients storage services:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree);
3. At least 02 years of apprenticeship in a suitable pharmacy establishment.

• Facility providing of drugs/drug ingredients storage services:

1. Pharmacy Practice Certificate;
2. A bachelor’s degree in pharmacy (Pharmacist degree) or a bachelor’s degree in general medicine or a bachelor's degree in biology;
3. At least 02 years of apprenticeship in a suitable pharmacy establishment.