Regulations on establishments with non-commercial pharmaceutical activities

Quy định về cơ sở có hoạt động dược không vì mục đích thương mại- Ảnh 1. — Non-commercial pharmaceutical activities include the activities of manufacturing, compounding, processing, preserving, transporting, and dispensing 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 pharmacy departments, pharmacy sections or activities of production, preparation, processing, preservation, transportation, dispensing of drugs, pharmaceutical ingredients, testing of drugs, pharmaceutical ingredients, bioequivalence testing of drugs, clinical trials of drugs; vaccination facilities; scientific and technological organizations, training facilities with research and teaching activities related to pharmacy.

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 establishments that do not generate profit.

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

Procedures for declaring a business establishment with organized drug 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 establishment has a pharmacy shelf. 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 in accordance with the provisions of Decree No. 45/2020/ND-CP dated April 8, 2020 of the Government on performing administrative procedures in the electronic environment, as 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 medical 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 announcing the business establishment eligible to organize a pharmacy shelf, and posting on the website 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, a written response must be provided 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 that organizes drug shelves.

5- Business establishments that organize drug shelves or drug shelves that are not in operation for 12 consecutive months without notifying the specialized health agency under the People's Committee of the province where the establishment 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