Dossier to request a Certificate of eligibility for pharmaceutical business for private pharmacies

1. What documents are needed to apply for a Certificate of eligibility for pharmaceutical business for a private pharmacy?

Pursuant to Article 32 of Decree 54/2017/ND-CP stipulating:

– Application for issuance, re-issuance, and adjustment of the Certificate of eligibility for pharmacy business according to Form No. 19, 20 and 21 in Appendix I issued attached to this Decree;

– Technical documents specified in Point b, Clause 1 and Point b, Clause 2, Article 38 of the Pharmacy Law include Certificate of eligibility for pharmaceutical business or Certificate of Good Practice at business location (if any) and the following technical documents:

+ For drug retail establishments: Documents on location, storage area, storage equipment, documents Technical expertise and personnel documents according to the principles of Good Practice for drug retail establishments.

+ For establishments specializing in retailing medicinal herbs, herbal medicines, and traditional medicines: Documents proving compliance with the provisions in Clause 5, Article 31 of this Decree according to the regulations of the Minister of Health;

– Documents specified in Clause 2 of this Article must be stamped with the establishment’s stamp on the outer cover page and stamped. overlapping marks on all remaining pages of the technical document. In case the establishment does not have a seal, it must have the signature of the legal representative of the establishment.

2. Who issues the Certificate of eligibility for pharmaceutical business for private pharmacies?

Article 37 of the Pharmacy Law 2016 stipulates the authority to issue, reissue, adjust and revoke Certificates of eligibility for pharmaceutical business as follows:

– The Minister of Health issues, reissues, adjusts and revokes Certificates of eligibility for pharmaceutical business for regulated pharmaceutical business establishments. at Points a, b, c, e, g and h, Clause 2, Article 32 of this Law.

– The Director of the Department of Health issues, reissues, adjusts and revokes the Certificate of eligibility for pharmaceutical business for pharmaceutical business establishments specified in Point d and Point dd, Clause 2, Article 32 of this Law.

In addition, Clause 2, Article 32 of the Pharmacy Law. 2016 regulates pharmaceutical business establishments including:

a) Establishments manufacturing drugs and medicinal ingredients;

b) Establishments exporting and importing drugs and medicinal ingredients;

c) Establishments providing storage services for drugs and medicinal ingredients;

d) Establishments that wholesale drugs and medicinal ingredients drugs;

đ) Drug retail establishments including pharmacies, pharmacy counters, medicine cabinets at commune health stations, establishments specializing in retailing medicinal herbs, herbal medicines, and traditional medicines;

e) Establishments providing drug testing services and medicinal ingredients;

g) Establishments providing clinical drug testing services; ready;

h) Establishment providing bioequivalence testing services for drugs.

Therefore, the Director of the Department of Health will issue a Certificate of eligibility for pharmaceutical business to a private pharmacy.

3. How many days does it take to issue a Certificate of eligibility for pharmaceutical business to a private pharmacy?

Article 39 of the Pharmacy Law 2016 stipulates the procedures for issuance, re-issuance, and adjustment of Papercertificate of eligibility for pharmacy business as follows:

Step 1: Application dossier for issuance, re-issuance, adjustment of Certificate of eligibility for pharmaceutical business submitted to the competent authority specified in Article 37 of this Law.

Step 2: Within 30 days from the date of receipt of complete application dossier; 20 days from the date of receipt of complete dossier requesting re-issuance or adjustment, the Minister of Health or Director of the Department of Health shall organize the evaluation and issue the Certificate of eligibility for pharmaceutical business according to authority; In case of non-issue, a written response must be provided clearly stating the reason.

In case of re-issuance due to the error of the agency issuing the Certificate of eligibility for pharmaceutical business, the applicant for the Certificate of eligibility for pharmacy business shall submit the application according to the provisions of Clause 3, Article 38 of this Law. The time limit for reissuing the Certificate of eligibility for pharmaceutical business is 07 working days from the date of receipt of complete documents.

Therefore, issuing a Certificate of eligibility for pharmaceutical business to a private pharmacy takes 30 days.