Procedure for the issuance of the Certificate of eligibility for pharmacy business

1

Receiving Authority

Department of Health where the facility is located[1]

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[2]

01 dossier includes:

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[3];
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 the following technical documents:

• For drugs wholesalers, drug ingredients:

Documents on premises, warehouses for storage of drugs, drug ingredients, storage equipment, means of transportation, quality control system, technical documents and personnel according to the principle of good distribution practice;

• For drug retailer, including drugstores, dispensaries of hospitals and medical stations of municipalities, retailers of herbal ingredients, herbal drugs, traditional drugs:

Documents on premises, a storage area, storage equipment, technical documents and personnel according to the principle of Good Retailing Practice.

4

Fees

• Appraisal of drug trade conditions for wholesale drug companies (GDP): VND 4,000,000/dossier;
• Appraisal of drug retail conditions and standards (GPP) or pharmacy practice standards and conditions for drug retailers that are not required to comply with the principles and standards of good pharmacy practice according to the roadmap: VND 1,000,000/facility;
• Appraisal of drug retailing conditions and standards (GPP) for retail outlets in disadvantaged, mountainous and island areas: VND 500,000/facility.

5

Result

Certificate of eligibility for pharmacy business

Wholesaler of drugs, medicinal ingredients [4]

Wholesalers of drugs, medicinal ingredients must have the premises, warehouses for storage drugs, medicinal ingredients, storage equipment, means of transportation, quality control system, technical documents and personnel according to the principle of Good Distribution Practices.

The head of pharmacist of a wholesaler of drug/drug ingredients wholesaler must have[5]:

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

Drug retailers are drugstores and dispensaries[6]

The drug retailer must have the premises, a storage area, storage equipment, technical documents and personnel according to the principle of Good Pharmacy Practices.

The head of pharmacist of a drugstore must have[7]:

• A Pharmacy Practice Certificate;
• A bachelor’s degree in pharmacy (pharmacist degree);
• At least 02 years of apprenticeship in a suitable pharmacy establishment.

Note: The head of pharmacist of a pharmacy may also be responsible for clinical pharmacology.

The head of pharmacist of a dispensary must have[8]:

• A Pharmacy Practice Certificate;
• One of the following degrees: Bachelor’s degree in pharmacy (pharmacist degree), college degree in pharmacy, associate degree in pharmacy;
• At least 18 months of apprenticeship in a suitable pharmacy establishment.