Procedures for issuance of pharmacy practice certificates through examination and application review in Vietnam

Legal Basis: Law on Pharmacy 2016; Decree 54/2017/ND-CP and Circular 277/2016/TT-BTC, Decree 155/2018/ND-CP.

1. Conditions:

1. Possessing diplomas, certificates, professional qualifications (hereinafter collectively referred to as professional qualifications) granted or recognized in Vietnam appropriate to the job position and pharmaceutical business establishments including:

a) University degree in pharmacy (hereinafter referred to as Pharmacist Degree);

b) University degree in general medicine;

c) University degree in traditional medicine or traditional pharmacy;

d) University degree in biology;

dd) University degree in chemistry;

e) College degree in pharmacy;

g) Intermediate degree in pharmacy;

h) College or intermediate degree in medicine;

i) Intermediate degree in traditional medicine or traditional pharmacy;

k) Primary pharmacy diploma or certificate;

l) Certificates for traditional medicine practitioners, traditional medicine books, or other diplomas, certificates in traditional medicine and pharmacy issued before the effective date of this Law.

The application of the conditions on diplomas, certificates, qualifications specified at Point l of this Clause shall be prescribed by the Minister of Health in accordance with the socio-economic development conditions and medical examination and treatment needs of the people in each locality in each period.

2. Having practice experience at a pharmaceutical business establishment, the pharmacy department of a medical examination and treatment facility, a specialized pharmacy training school, a pharmaceutical research facility, a drug testing facility, raw medicinal material testing facility, pharmaceutical management agency, or the representative office of a foreign trader operating in the pharmaceutical field in Vietnam (hereinafter collectively referred to as pharmaceutical facilities); medical examination and treatment facilities appropriate to the practitioner's specialization as prescribed below:

a) For persons whose pharmacy practice certificates have been revoked as prescribed in Clause 9, Article 28 of the Law on Pharmacy 2016, practice experience is not required but must update pharmaceutical professional knowledge;

b) For persons with postgraduate specialization appropriate to the scope of practice, practice experience time is reduced as prescribed by the Government of Vietnam;

c) For persons with professional diplomas specified at Point l, Clause 1, Article 13 of the Law on Pharmacy 2016, practice experience time is as prescribed by the Minister of Health.

3. Possessing a health certificate issued by a competent medical facility indicating physical fitness to practice pharmacy.

4. Not falling into one of the following cases:

a) Being prosecuted for criminal liability, serving a sentence, or a court decision; during the period of being banned from practicing, banned from working related to pharmaceutical activities according to the court's verdict or decision;

b) Having limited legal capacity.

5. Persons voluntarily applying for a pharmaceutical practice certificate through an exam must meet the conditions prescribed in Article 13 of the Law on Pharmacy 2016.

2. Components of the dossier:

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

- Notarized copy of professional qualifications. For diplomas issued by foreign training institutions, a notarized copy of the equivalence recognition certificate by the competent authority is required according to Clause 2, Article 18 of Decree 54/2017/ND-CP;

- Original or notarized copy of the health certificate issued by the medical examination and treatment facility according to the Law on Medical Examination and Treatment;

- Original or notarized copy of the Practice Time Certificate according to Form No. 03 in Appendix I issued with Decree 54/2017/ND-CP. In the case of practice at multiple establishments, the practice time is the sum of practice times at each establishment, and each establishment must issue a Practice Time Certificate;

- In case of applying for a Pharmaceutical Practice Certificate for different activity scopes requiring different practice times and practice establishments, the dossier must have a Practice Time Certificate and specialty practice content from one or more establishments meeting the requirements of each scope and position of practice. If the scopes of specialized activities have the same practice time and practice establishments’ requirements, separate certificates for each activity scope are not required;

- Original or notarized copy of the exam result certificate issued by the exam organizing institution according to Clause 2, Article 28 of Decree 54/2017/ND-CP for the case of Pharmaceutical Practice Certificate through examination;

- For foreigners and Vietnamese residing abroad applying for a Pharmaceutical Practice Certificate through dossier review, documents proving language proficiency must be provided according to Clause 2, Article 14 of the Law on Pharmacy.

Note: Documents issued by competent foreign authorities must be consularly legalized as prescribed. These documents must be translated into Vietnamese and notarized as prescribed.

3. Procedure for implementation:

- The applicant submits the dossier directly or by postal service to:

+ Ministry of Health for the case of applying for a Pharmaceutical Practice Certificate through examination;

+ Department of Health for the case of applying for a Pharmaceutical Practice Certificate through dossier review.

- Upon receiving the dossier, the receiving agency issues a Dossier Receipt Form according to Form No. 01 in Appendix I issued with Decree 54/2017/ND-CP to the applicant.

- In the absence of requests for dossier amendment or supplementation, the agency granting the Pharmaceutical Practice Certificate is responsible for:

+ Issuing the Pharmaceutical Practice Certificate within 15 days from the date on the Dossier Receipt Form; in case of non-issuance, a written reply stating clear reasons must be provided;

+ Issuing the Pharmaceutical Practice Certificate within 05 working days from the date on the Dossier Receipt Form for the case of a revoked Pharmaceutical Practice Certificate according to Clause 3, Article 28 of the Law on Pharmacy; in case of non-issuance, a written reply stating clear reasons must be provided;

- If there are requests for dossier amendment or supplementation, the receiving agency provides a written notification of the required amendment or supplementation to the applicant within the following timelines:

+ 10 days from the date on the Dossier Receipt Form for an application for a Pharmaceutical Practice Certificate;

- After receiving the amended or supplemented dossier, the receiving agency issues a Dossier Receipt Form for amendment or supplementation according to Form No. 01 in Appendix I issued with Decree 54/2017/ND-CP to the applicant.

+ If the amended or supplemented dossier does not meet the requirements, the receiving agency provides a written notification to the applicant according to Clause 4, Article 6 of Decree 54/2017/ND-CP;

+ If there are no requests for amendment or supplementation of the amended or supplemented dossier, the receiving agency proceeds according to Clause 3, Article 6 of Decree 54/2017/ND-CP.

- Within 06 months from the date the receiving agency issues a written notification for amendment or supplementation, the applicant must submit the required amended or supplemented dossier. After this period, if the applicant does not amend or supplement, or after 12 months from the first submission and the supplemented dossier does not meet the requirements, the initial dossier submitted is invalid.

- Within 05 working days from the date of issuing the Pharmaceutical Practice Certificate, the receiving agency publishes and updates the following information on its electronic portal:

+ Name, date of birth of the recipient of the Pharmaceutical Practice Certificate;

+ Number of the Pharmaceutical Practice Certificate;

+ Scope of professional activity.

4. Authority to issue: Ministry of Health (examination form); Department of Health (dossier review form).

5. Time limit for resolution: 20 working days from the date of receiving a complete dossier.

6. Fee: VND 500,000/application.

7. Validity duration of the certificate: Not specified.

NOTE: This procedure applies to cases of applying for the initial Pharmaceutical Practice Certificate and cases of re-application after revocation under Clauses 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, Article 28 of the Law on Pharmacy 2016. If the Pharmaceutical Practice Certificate is revoked under Clauses 4, 6, 10, or 11, Article 28 of the Law on Pharmacy 2016, it can only be re-issued after 12 months from the revocation date.

For understanding conditions, standards, dossiers, procedures for applying for other practice certificates, please refer to: Practice Certificate Lookup.

Sincerely!