Regulations on establishments with pharmaceutical activities for non-commercial purposes

Quy định về cơ sở có hoạt động dược không vì mục đích thương mại- Ảnh 1. — Non-commercial pharmaceutical activities include the production, compounding, processing, storage, transportation, and dispensing of medicines and pharmaceutical raw materials.

Specifically, the Circular clearly defines establishments engaged in non-commercial pharmaceutical activities. Accordingly, establishments engaged in non-commercial pharmaceutical activities include the following:

a- Public non-profit organization.

b) Facilities belonging to the armed forces that engage in pharmaceutical activities but are not pharmaceutical businesses and do not fall under the cases specified in point d, clause 1, Article 35 of the Law on Pharmaceuticals.

c) Medical examination and treatment facilities, drug rehabilitation centers, and other medical facilities with a pharmacy department or unit, or engaged in the production, compounding, processing, storage, transportation, dispensing of drugs and drug raw materials, testing of drugs and drug raw materials, bioequivalence testing of drugs, and clinical trials of drugs; vaccination centers; scientific and technological organizations and training institutions with research and teaching activities related to pharmacy.

Non-commercial pharmaceutical activities include the production, compounding, processing, storage, transportation, dispensing of drugs and drug raw materials, testing of drugs and drug raw materials, bioequivalence testing of drugs, and clinical trials of drugs by facilities that do not generate profit.

The assessment of compliance with Good Practice for non-commercial pharmaceutical facilities is carried out in accordance with the Good Practice regulations issued by the Minister of Health .

Procedures for announcing business establishments with organized drug shelves.

According to the regulations, before commencing operations, businesses with organized drug shelves must submit one set of documents announcing the establishment of a business with organized drug shelves to the specialized health agency under the People's Committee of the province where the drug shelves are located. The submission of documents must comply with the provisions of Article 15 of Government Decree No. 118/2025/ND-CP dated June 9, 2025, on the implementation of administrative procedures under the one-stop and integrated one-stop mechanisms at the One-Stop Service Center and the National Public Service Portal.

In cases where applications are submitted through the online public service portal, the applicant must comply with the regulations stipulated in Government Decree No. 45/2020/ND-CP dated April 8, 2020, on the implementation of administrative procedures in the electronic environment, as amended and supplemented by Government Decree No. 59/2022/ND-CP dated September 5, 2022, on electronic identification and authentication, Government Decree No. 68/2024/ND-CP dated June 25, 2024, on specialized digital signatures for public service, and Government Decree No. 69/2024/ND-CP dated June 25, 2024, on electronic identification and authentication.

Upon receiving the application, the specialized health agency under the Provincial People's Committee issues the business establishment with drug shelves a "Receipt of Application for Announcement" form according to the prescribed mẫu (template).

Within 05 working days from the date indicated on the application receipt form, the specialized health agency under the Provincial People's Committee is responsible for issuing a Decision announcing the business establishments that meet the conditions for organizing drug shelves, and publishing the list of eligible business establishments with drug shelves on the website of the specialized health agency under the Provincial People's Committee. If the announcement is not made, a written response stating the reasons must be provided.

Cases of cancellation of the announcement of business establishments with organized drug shelves.

The circular stipulates that the cases in which the announcement of a business establishment with organized drug shelves may be revoked include:

1. Terminate the operation of the drug shelf or terminate the operation of the business establishment that has a drug shelf.

2. Business establishments with organized drug shelving that does not meet one of the regulations in point b, clause 2, Article 35 of the Law on Pharmaceuticals.

3. The content of the announcement regarding the establishment's organized drug shelves is either not within the proper authority or contains content that violates the law.

4. Falsifying documents in the application file for the establishment of a business with organized drug shelves.

5. Businesses that have drug shelves or whose drug shelves are not in operation for 12 consecutive months without notifying the specialized health agency under the People's Committee of the province where the drug shelves are located.

Minh Hien

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