Vietnam: Form of application for a Pharmacy Practice Certificate and instructions for filling out the form

Hello, Lawnet would like to answer as follows:

1. What does an application for a Pharmacy Practice Certificate include?

According to Article 3 of Decree 54/2017/ND-CP, the application for the pharmacy practice certificate includes:

- An application for the pharmacy practice certificate mentioned in Article 24 of the Law on Pharmacy 2016 consists of:

+ The application form No. 02 in Appendix I enclosed with Decree 54/2017/ND-CP, 02 portrait pictures (4x6 cm) of the applicant on a white background which was taken within the last 6 months;

+ Certified true copy of the applicant’s qualification. If the qualification is issued overseas, its certified true copy must be enclosed with an equivalence certification issued by a competent authority specified in Clause 2 Article 18 of Decree 54/2017/ND-CP;

+ The original copy or certified true copy of the health certificate issued by a medical facility in accordance with the Law on Medical examination and treatment;

+ The original copy or certified true copy of the certificate of internship (Form 03 in Appendix I enclosed herewith). If the internship took place in more than one facility, the internship duration will be the total duration of internship at the facilities according to the certificates of internship issued by such facilities;

+ If the scope of practice covered by the pharmacy practice certificate applied for requires different internship durations and facilities, the application shall be enclosed with a certificate of internship of one or several facilities that meet requirements of each position.

+ The original copy or certified true copy of the confirmation of examination result specified in Clause 2 Article 28 of Decree 54/2017/ND-CP if the pharmacy practice certificate has to be obtained after passing an examination;

+ If the applicant is a foreigner or a Vietnamese citizen residing overseas applying for the pharmacy practice certificate without taking an examination, documents proving the applicant’s language proficiency specified in Clause 2 Article 14 of the Law on Pharmacy 2016.

- Documents issued by overseas competent authorities must be consularly legalized and enclosed with notarized Vietnamese translations.

- Only 01 set of documents is required.

Thus, the application for the pharmacy practice certificate will include documents such as:

- Application according to the prescribed form;

- Certified true copy of the applicant’s qualification; if the qualification is issued overseas, its certified true copy must be enclosed with an equivalence certification

-Certificate of internship according to regulations;

- Confirmation of examination result (if there is an exam);

- Foreign documents must be consularly legalized and have a notarized translation.

2. Form of application for a Pharmacy Practice Certificate and instructions for filling out the form

Form of application for a Pharmacy Practice Certificate (issued together with Decree 155/2018/ND-CP):  Download 

Instructions for filling out the form of application for a Pharmacy Practice Certificate

(1) Name of the agency issuing People's Republic of Citizenship.

(2) Place name.

(3) Practice positions according to regulations from Article 15 to Article 22 of the Law on Pharmacy 2016, specifically:

- The person responsible for the pharmaceutical expertise of the drug manufacturing facility, except for cases 2 and 3 below.

- The person responsible for pharmaceutical expertise at a facility that produces medicinal ingredients such as pharmaceutical ingredients, excipients, and capsule shells.

- The person responsible for the pharmaceutical expertise of the facility producing vaccines, biological products, and raw materials for the production of vaccines and biological products.

- The person in charge of quality assurance of the drug manufacturing facility, except for cases 5 and 6 below.

- Person in charge of quality assurance at vaccine and biological product manufacturing facilities.

- The person in charge of quality assurance of the facility producing medicinal ingredients such as pharmaceutical ingredients, excipients, and capsule shells.

- The person responsible for pharmaceutical expertise, the person in charge of quality assurance of the pharmaceutical manufacturing facility;

- The person responsible for pharmaceutical expertise, the person in charge of quality assurance for business households and pharmaceutical production cooperatives.

- The person responsible for the pharmaceutical expertise of an establishment that wholesales drugs and medicinal ingredients, except for cases 10 and 11 below.

- Person responsible for the pharmaceutical expertise of a vaccine and biological product wholesale facility.

- Person in charge of the pharmaceutical expertise of establishments that wholesale medicinal materials, herbal drugs, and traditional drugs.

- Person responsible for the pharmaceutical expertise of an establishment exporting or importing drugs or medicinal ingredients, except for cases 13 and 14 below.

- Person responsible for the pharmaceutical expertise of establishments exporting or importing vaccines and biological products.

- Person responsible for the pharmaceutical expertise of establishments that export or import medicinal materials, herbal drugs, or traditional drugs.

- Person responsible for the pharmaceutical expertise of the pharmacy.

- Person responsible for pharmacy expertise at the pharmacy.

- Person responsible for the professional pharmacy of the commune health station medicine cabinet

- Person in charge of the pharmaceutical expertise of an establishment specializing in retailing medicinal herbs, herbal medicines, and traditional medicines.

- Person in charge of the pharmaceutical expertise of an establishment providing drug testing services and medicinal ingredients, except for case 20 below.

- Person responsible for the pharmaceutical expertise of an establishment providing vaccine and biological product testing services,

- Person in charge of the pharmaceutical expertise of establishments providing clinical drug testing services and bioequivalence testing of drugs, except for case 22 below.

- Person in charge of the expertise of establishments providing clinical drug testing services and bioequivalence testing of herbal drugs and traditional drugs.

- Person in charge of clinical pharmacy work at a medical examination and treatment facility, except for case 24 below.

- Person in charge of the clinical pharmacy work of a medical examination and treatment facility using traditional medicine.

3. What are the cases in which the pharmacy practice certificate is revoked in Vietnam?

According to the provisions of Article 28 of the Law on Pharmacy 2016, cases in which the pharmacy practice certificate is revoked include:

- The pharmacy practice certificate is issued ultra vires.

- The holder of the pharmacy practice certificate requests its revocation.

- The pharmacy practice certificate is incorrect because of the issuing authority.

- The application for the pharmacy practice certificate contains counterfeit documents.

- A person has more than one pharmacy practice certificate.

- The holder of a pharmacy practice certificate rents it, lends it, leases it, borrows it or allows another person to use it.

- A person issued with the pharmacy practice certificate fails to satisfy any of the conditions for issuance of the pharmacy practice certificate specified in Article 13 or Clause 2 Article 14 of the Law on Pharmacy 2016.

- A person issued with the pharmacy practice certificate fails to practice for 12 consecutive months.

- A pharmacy practitioner does not have the certificate of completion of training program and refresher program in pharmacy within 03 years from the issuance date of the pharmacy practice certificate or the issuance date of the latest certificate of completion of training program and refresher program in pharmacy.

- The certificate holder violates the code of ethics for pharmacy practitioners and causes harm to other people’s health or life.

- A person has had his/her pharmacy practice certificate revoked more than once for the same violation.

Best regards!

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