Regulations on establishments with pharmaceutical activities for non-commercial purposes

(Chinhphu.vn) - The Ministry of Health has issued Circular 31/2025/TT-BYT detailing a number of articles of the Law on Pharmacy and Decree No. 163/2025/ND-CP dated June 29, 2025 of the Government detailing a number of articles and measures to organize and guide the implementation of the Law on Pharmacy.

Non-commercial pharmaceutical activities include the production, preparation, processing, preservation, transportation, and dispensing of drugs and pharmaceutical ingredients.

In particular, the Circular clearly stipulates establishments with non-commercial pharmaceutical activities. Accordingly, establishments with non-commercial pharmaceutical activities include the following establishments:

a- Public service unit.

b- Facilities belonging to the armed forces that have pharmaceutical activities but are not pharmaceutical business establishments and do not fall under the cases specified in Point d, Clause 1, Article 35 of the Law on Pharmacy.

c- Medical examination and treatment facilities, drug rehabilitation facilities, other medical facilities with pharmaceutical departments, pharmaceutical sections or activities of production, preparation, processing, preservation, transportation, dispensing of drugs, pharmaceutical ingredients, testing of drugs, pharmaceutical ingredients, bioequivalence testing of drugs, clinical drug trials; vaccination facilities; scientific and technological organizations, training facilities with research and teaching activities related to pharmaceuticals.

Non-commercial pharmaceutical activities include the production, preparation, processing, preservation, transportation, dispensing of drugs, pharmaceutical ingredients, testing of drugs, pharmaceutical ingredients, bioequivalence testing of drugs, and clinical drug trials of facilities that do not generate profit.

Assessment of compliance with Good Practices of establishments engaged in non-commercial pharmaceutical activities shall be carried out in accordance with the regulations on Good Practices issued by the Minister of Health .

Procedures for declaring a business establishment with organized pharmacy shelves

According to the Circular, before operating, a business establishment that organizes a pharmacy shelf must submit 01 set of documents declaring that the business establishment has organized a pharmacy shelf to the specialized health agency under the People's Committee of the province where the pharmacy shelf is located. The submission of documents is carried out in accordance with the provisions of Article 15 of Decree No. 118/2025/ND-CP dated June 9, 2025 of the Government on implementing administrative procedures under the one-stop, one-stop mechanism at the One-stop Department and the National Public Service Portal.

In case of submitting documents on the Online Public Service Portal, the facility shall submit documents according to the provisions of Decree No. 45/2020/ND-CP dated April 8, 2020 of the Government on performing administrative procedures in the electronic environment, which has been amended and supplemented by Decree No. 59/2022/ND-CP dated September 5, 2022 of the Government regulating electronic identification and authentication, Decree No. 68/2024/ND-CP dated June 25, 2024 of the Government regulating digital signatures for specialized public services, Decree No. 69/2024/ND-CP dated June 25, 2024 of the Government regulating electronic identification and authentication.

Upon receiving the dossier, the specialized health agency under the Provincial People's Committee shall issue to the business establishment that organizes the pharmacy shelf a Receipt of the dossier for declaration according to the form.

Within 05 working days from the date of receipt of the application, the health professional agency under the Provincial People's Committee shall be responsible for issuing a Decision to announce the business establishment eligible to organize a pharmacy shelf, and posting on the Electronic Information Page of the health professional agency under the Provincial People's Committee the list of business establishments eligible to organize a pharmacy shelf. In case of non-announcement, there must be a written reply stating the reason.

Cases of cancellation of declaration of business establishments with organized drug shelves

The Circular stipulates that cases of cancellation of declaration of business establishments with organized drug shelves include:

1- Terminate the operation of the pharmacy shelf or terminate the operation of the business establishment that organizes the pharmacy shelf.

2- Business establishments that organize drug shelves that do not meet one of the regulations in Point b, Clause 2, Article 35 of the Law on Pharmacy.

3- The content of the announcement of the business establishment organizing the pharmacy shelves is not within the authority or has illegal content.

4- Forging documents in the declaration file of a business establishment with organized drug shelves.

5- Business establishments that organize drug shelves or drug shelves that are inactive for 12 consecutive months without notifying the specialized health agency under the People's Committee of the province where the facility places the drug shelves.

Minh Hien

Source: https://baochinhphu.vn/quy-dinh-ve-co-so-co-hoat-dong-duoc-khong-vi-muc-dich-thuong-mai-102250709165716467.htm