A pharmaceutical business enterprise satisfying the conditions prescribed by law shall prepare a set of dossiers of application for Certificate of eligibility for pharmacy business and send it to the Ministry of Health or the Department of Health on a case-by-case basis to be considered for issuance of a Certificate.
Article table of contents
According to Article 38 of the Law on Pharmacy 2016 of Vietnam, an application for issuance, reissuance, adjustment of Certificate of eligibility for pharmacy business is specified as follows:
- An application for the Certificate of eligibility for pharmacy business in the cases an establishment applying for the certificate for the first time and an establishment whose Certificate of eligibility for pharmacy business is revoked consists of:
+ 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 of the Law on Pharmacy 2016;
+ 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.
- An application for the Certificate of eligibility for pharmacy business in the cases an establishment that already has a Certificate of eligibility for pharmacy business but then changes its scope of business and thus changes the applicable conditions; or changes the business location shall consist of:
+ An application form for issuance of the Certificate of eligibility for pharmacy business;
+ Technical documents corresponding to the changes;
+ 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.
- An application for reissuance of a Certificate of eligibility for pharmacy business consists of:
+ An application form for reissuance of the Certificate of eligibility for pharmacy business;
+ The Certificate of eligibility for pharmacy business that is incorrect because of the issuing authority in the case mentioned in Point b Clause 2 Article 36 of the Law on Pharmacy 2016.
- An application for adjustments to a Certificate of eligibility for pharmacy business consists of:
+ An application form for adjustments to the Certificate of eligibility for pharmacy business;
+ A certified true copy of the pharmacy practice certificate if the position that requires the pharmacy practice certificate is changed;
+ A certified true copy of the certificate of enterprise registration or legal documents proving the change in the name or address of the establishment.
Application for issuance, reissuance, adjustment of Certificate of eligibility for pharmacy business is detailed in Article 32 of Decree No. 54/2017/NĐ-CP of Vietnam’s Government.
Nguyen Trinh
- Key word:
- Law on Pharmacy 2016
- Decree No. 54/2017/NĐ-CP
