The procedures for issuance of the Certificate of Eligibility for pharmacy business and GPP of the Clinic

Enterprises that want to operate in the field of pharmaceutical business need to carry out the procedures for applying for a Certificate of eligibility for pharmacy business and a license to meet GPP standards of the clinic by the law. Because this is a conditional business, the licensing process is relatively complicated. The following is the procedure and process for the issuance of the Certificate of Eligibility for pharmacy business and GPP of the Clinic, to help readers understand this issue.

The procedures for issuance of the Certificate of Eligibility for pharmacy business and GPP of the Clinic

Dossier includes

• An application form for issuance of the Certificate of Eligibility for pharmacy business;
• Corresponding technical documents of the pharmacy business establishment specified in Clause 2 Article 32 hereof:
  • technical documents and personnel
  • Documents on the location, storage area, and storage equipment.

The documents must bear the applicant’s seal on the cover and fan stamping on the inner pages. If the applicant does not have a seal, the legal representative’s signature is required.

• 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.

(Legal basis: Clause 1, Article 38 of the Law on Pharmacy 2016)

Place of application (for the clinic): Local Department of Health

Processing time: 30 days

Implementation process

• Within 05 days from the receipt of a valid and satisfactory application, the Provincial Department of Health shall establish an inspection team and inform the applicant of the site inspection conducted at its premises and the expected inspection date. Within 15 days from the date of notification, the inspection team shall conduct a site inspection at the pharmacy premises.
• Within 10 days from the completion of the site inspection and obtainment of a valid inspection report, the Provincial Department of Health shall issue the Certificate of eligibility for pharmacy business or GPP Certificate to the qualified pharmacy.

If the inspection report indicates that the pharmacy is required to submit a report on corrective actions

• Within 05 days from the completion of the site inspection at the pharmacy premises and obtainment of a valid inspection report, the Provincial Department of Health shall request the pharmacy in writing to take corrective actions against its deficiencies specified in the inspection report;
• Upon completion of corrective actions, the pharmacy must send a written report, accompanied by evidence of its completion of such corrective actions against the deficiencies specified in the inspection report (such as documents, photographs, videos, and certifications);
• Within 20 days from the receipt of the written report on corrective actions, the Provincial Department of Health shall evaluate the results of corrective actions taken by the pharmacy and conclude the degree of fulfillment of GPP requirements by the pharmacy:
• If the pharmacy has fulfilled the GPP requirements, the Provincial Department of Health shall issue the Certificate of eligibility for pharmacy business and/or GPP Certificate according to Form No. 03 in Appendix III enclosed Circular 02/2018/TT-BYT.

Within 05 days from the date of issuance of the Certificate of Eligibility for pharmacy business or GPP Certificate, the Provincial Department of Health shall publish the following information on its website:

• Name and address of the pharmacy;
• Full name of the responsible pharmacist, number of his/her pharmacy practice certificate;
• Numbers of the Certificate of eligibility for pharmacy business and GPP Certificate (if any);
• Validity of inspection of the fulfillment of GPP requirements;
• The scope of operations of the pharmacy.