Procedure for Reissuance of Pharmaceutical Practice Certificates by Examination and Dossier Review

Legal Basis: Law on Pharmacy 2016; Decree 54/2017/ND-CP and Circular 277/2016/TT-BTC

1. Conditions: Reissuance of the Pharmacy Practice Certificate applies in the case of loss or damage.

2. Application Components:

- Application for reissuance of the Pharmacy Practice Certificate according to Form No. 04 in Appendix I issued with Decree 54/2017/ND-CP, 02 portrait photos sized 4 cm x 6 cm of the applicant taken on a white background within the last 06 months;

- Copy of the previously issued Pharmacy Practice Certificate except in cases of loss of the certificate.

3. Implementation Procedure:

- The applicant for reissuance of the Pharmacy Practice Certificate submits the application directly or by post to:

+ The Ministry of Health for requests for reissuance through the examination form;

+ The Department of Health for requests for reissuance through the dossier assessment form.

- Upon receipt of the application, the receiving agency gives the applicant a Receipt according to Form No. 01 in Appendix I issued with Decree 54/2017/ND-CP.

- If there is no request for amendment or supplementation of the application, the agency responsible for reissuing the Pharmacy Practice Certificate must:

+ Reissue the Pharmacy Practice Certificate within 10 days from the date noted on the Receipt; if not, provide a written explanation stating the reason.

- If there is a request to amend or supplement the application, the receiving agency will issue a notice outlining the required amendments or supplements to the applicant within:

+ 05 working days from the date noted on the Receipt for applications for reissuance of the Pharmacy Practice Certificate.

- After receiving the amended or supplemented application, the receiving agency gives the applicant a receipt for the amended or supplemented application according to Form No. 01 in Appendix I issued with Decree 54/2017/ND-CP.

+ If the amended or supplemented application does not meet the requirements, the receiving agency will notify the applicant for reissuance of the Pharmacy Practice Certificate as per Clause 4, Article 6 of Decree 54/2017/ND-CP;

+ If there is no requirement to amend or supplement the amended or supplemented application, the receiving agency will proceed according to Clause 3, Article 6 of Decree 54/2017/ND-CP.

- Within 06 months from the date the receiving agency issues a notice requesting amendment or supplementation, the applicant must submit the required amended or supplemented application. After this period, if the applicant does not amend or supplement or if after 12 months from the first submission the supplemented application still does not meet the requirements, the previously submitted application becomes invalid.

- Within 05 working days from the date of reissuance of the Pharmacy Practice Certificate, the receiving agency will publish and update the following information on the unit's electronic portal:

+ Name, date of birth of the individual issued the Pharmacy Practice Certificate;

+ Number of the Pharmacy Practice Certificate;

+ Scope of professional activity.

4. Authority for Reissuance: Ministry of Health (examination form); Department of Health (dossier assessment form).

5. Resolution Time: 10 working days from the date of receiving a complete application.

6. Fee: 500,000 VND/application. 7. Certificate Validity: Unspecified. For information on conditions, standards, dossiers, and procedures for applying for other practice certificates, please refer to: Practice Certificate Search

Sincerely!