Cases in which the Certificate of eligibility for pharmacy business is revoked in Vietnam

Cases in which the Certificate of eligibility for pharmacy business is revoked in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. Cases in which the Certificate of eligibility for pharmacy business is revoked in Vietnam

Cases in which the Certificate of eligibility for pharmacy business is revoked according to Article 40 of the Law on Pharmacy 2016 include:

- The pharmacy business is shut down.

- Any of the conditions for issuance of the Certificate of eligibility for pharmacy business specified in Article 33 and Article 34 of the Law on Pharmacy 2016 is not satisfied.

- The Certificate of eligibility for pharmacy business is issued ultra vires or against the law.

- The pharmacy business is not operating for 12 consecutive months without notifying a pharmacy authority.

2. Procedures for issuance of the Certificate of eligibility for pharmacy business in Vietnam

Procedures for issuance of the Certificate of eligibility for pharmacy business according to Article 35 of Decree 54/2017/ND-CP are as follows:

- Within 05 working days from the day on which the proposal to revoke the Certificate of eligibility for pharmacy business is received or from the discovery of the cases mentioned in Article 40 of the Law on Pharmacy, the issuing authority shall revoke the Certificate of eligibility for pharmacy business it issued, or respond the proposing authority and provide explanation in writing if such proposal is rejected.

- Within 05 working days from the day on which the decision to revoke the Certificate of eligibility for pharmacy business is issued, the issuer shall:

+ Post such decision on its website and send it to the Ministry of Health and Departments of Health nationwide;

+ Update information about revocation on its website.

- Within 05 working days from the day on which the decision to revoke the Certificate of eligibility for pharmacy business is received, the Ministry of Health and the Departments of Health mentioned shall post it on their websites.

3. Issuance, reissuance, adjustment of Certificate of eligibility for pharmacy business in Vietnam

 Issuance, reissuance, adjustment of Certificate of eligibility for pharmacy business according to Article 36 of the Law on Pharmacy 2016 as follows:

- The Certificate of eligibility for pharmacy business shall be issued to:

+ Any establishment applying for the certificate for the first time;

+ Any 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;

+ Any establishment whose Certificate of eligibility for pharmacy business is revoked as prescribed in Section 1.

- The Certificate of eligibility for pharmacy business shall be reissued when:

+ The Certificate of eligibility for pharmacy business is lost or damaged;

+ Information on the Certificate of eligibility for pharmacy business is incorrect because of the issuing authority.

- The Certificate of eligibility for pharmacy business shall be adjusted in case of changes to the name of the establishment, business location, person in charge, or scope of pharmacy business without changing the conditions for pharmacy business.

4. The power to issue, reissue, adjust, revoke Certificates of eligibility for pharmacy business in Vietnam

The power to issue, reissue, adjust, revoke Certificates of eligibility for pharmacy business according to Article 37 of the Law on Pharmacy 2016 is as follows:

- The Minister of Health shall issue, reissue, adjust, revoke Certificates of eligibility for pharmacy business of the pharmacy business establishments mentioned in Point a, b, c, e, g, and h Clause 2 of Article 32 of the Law on Pharmacy 2016.

- Directors of Provincial Departments of Health shall issue, reissue, adjust, revoke Certificates of eligibility for pharmacy business of the pharmacy business establishments mentioned in Point d and dd Clause 2 of Article 32 of the Law on Pharmacy 2016.

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