Latest regulations related to pharmacy business in Vietnam in 2018

Recently, the Ministry of Health of Vietnam has issued Circular No. 07/2018/TT-BYT on guidelines for some articles on pharmacy business of the Law on Pharmacy and the Decree No. 54/2017/ND-CP, which specifies notable changes as follows:

1. Notification of the list of practitioners who have pharmacy practice certificates shall be sent to the competent authority within 30 days

Within 30 days from the date starting the business or having changes of holders of pharmacy practice certificates, the pharmacy business establishment shall notify the Department of Health about the list of these holders, and also attach the file or update online as guided by the Department of Health.

2. Criteria for issuing the certificates of fluency in Vietnamese language in practicing pharmacy in Vietnam for foreigners

Foreigners and overseas Vietnamese must be recognized as fluent in Vietnamese or fluent in another language as prescribed when practicing pharmacy based on the following criteria:

- To be tested and recognized by an educational institution according to regulations to know Vietnamese fluently;

- In case of registration of a language other than the mother tongue or Vietnamese for practice, it must be tested and recognized as proficient by an educational institution according to regulations.

The practitioner who obtains a certificate of fluency in Vietnamese language or in the language which he/she uses to practice pharmacy but is not required to do the test if he/she:

- Has an associate degree or higher in medicine or pharmacy or in traditional medicine which is issued by a Vietnamese or foreign legal educational institution where the teaching language is Vietnamese or the language which the practitioner uses to practice pharmacy.

- Has a certificate of training in medicine or pharmacy or in traditional medicine with a duration for at least 12 (twelve) months which is issued by the educational institution where the teaching language is Vietnamese or the language that the practitioner uses to practice pharmacy.

- Has a college degree in medicine or pharmacy or in traditional medicine which is issued by a Vietnamese or foreign legal educational institution where the teaching language is Vietnamese or the language which the practitioner uses to practice pharmacy.

3. Promulgating the List of drugs restricted from retailing

The List of drugs restricted from retailing is provided in Appendix III attached to Circular No. 07/2018/TT-BYT of the Ministry of Health of Vietnam with contents: active ingredients; using method; dosage form, concentration limit, dose; detailed rules.

4. Standards for the sale representative of the pharmacy

The sale representative of the pharmacy is granted a sale representative card by the head of the pharmacy business establishment to introduce drugs to medicine practitioners.

The sale representative shall satisfy the following requirements:

- Having a college degree or higher in medicine or pharmacy.

- Being recruited and trained by the pharmacy business establishment for professional skills related to introducing drugs and understanding the legislative documents on Pharmacy.

Circular No. 07/2018/TT-BYT of the Ministry of Health of Vietnam officially takes effect from Jun 01, 2018.

- Ha Linh -

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