Simplify many administrative procedures in pharmaceutical business and cosmetic production

The Prime Minister issued Decision No. 2111/QD-TTg dated September 22, 2025 approving the Plan to reduce and simplify administrative procedures and conditions related to production and business activities within the scope and management functions of the Ministry of Health in 2025.

Checking product quality at a cosmetics factory. Illustration photo: Phuong Hoa/VNA

Specifically, the Decision approved the reduction and simplification of regulations on administrative procedures in 5 areas: trading in chemicals, insecticides, disinfectants used in the medical household sector; pharmaceutical trading; cosmetics production; trading in voluntary drug addiction treatment services, smoking cessation, HIV/AIDS treatment, care for the elderly, people with disabilities, and children; and food trading under the authority of the Ministry of Health .

The decision also approved the reduction and simplification of regulations on business conditions for two fields: cosmetic surgery service business; medical equipment business.

Simplify procedures for granting, re-granting and adjusting pharmaceutical business certificates

Regarding the pharmaceutical business sector, the Decision reduces, simplifies the issuance/re-issuance and adjustment of Certificates of eligibility for pharmaceutical business under the authority of the Ministry of Health for establishments manufacturing drugs and pharmaceutical ingredients; establishments exporting and importing drugs and pharmaceutical ingredients; establishments providing drug and pharmaceutical ingredient preservation services; establishments providing drug and pharmaceutical ingredient testing services; establishments providing drug bioequivalence testing services; establishments organizing pharmacy chains; and establishments providing clinical drug trial services. The specific simplification contents are as follows:

Remove the regulation that "the job position specified in Article 11 of the Law on Pharmacy must have a Pharmacy Practice Certificate (specified in Clause 2, Article 33 of the Law on Pharmacy)" under the condition: "For establishments importing drugs and pharmaceutical ingredients: The person responsible for pharmaceutical expertise and the job position specified in Article 11 of the Law on Pharmacy must have a Pharmacy Practice Certificate appropriate to the pharmaceutical business establishment specified in Clause 2, Article 32 of the Law on Pharmacy".

Reducing the conditions for importing drugs and pharmaceutical ingredients: delivery and receipt of radioactive drugs, the deliverer and recipient of radioactive drugs must have additional radiation safety certificates according to regulations of the Ministry of Science and Technology (stipulated in Clause 1, Article 33 of Decree No. 163/2025/ND-CP).

Reducing the conditions for importing drugs and pharmaceutical ingredients: In case of transporting radioactive drugs, the transporter must bring an additional radiation safety certificate (stipulated in Clause 2, Article 33 of Decree No. 163/2025/ND-CP).

Reducing the conditions for importing drugs and pharmaceutical ingredients: In case of transporting radioactive drugs, radiation safety must be ensured in accordance with the regulations on safe transportation of radioactive materials issued by the Minister of Science and Technology (stipulated in Clause 4, Article 33 of Decree No. 163/2025/ND-CP).

Reducing the conditions for facilities importing drugs and pharmaceutical ingredients: Facilities participating in the process of delivering and receiving radioactive drugs must have a license to conduct radiation work within the scope of transporting radioactive sources according to the regulations of the Ministry of Science and Technology (stipulated in Clause 5, Article 33 of Decree No. 163/2025/ND-CP).

Remove the regulation that "the job position specified in Article 11 of the Law on Pharmacy must have a Pharmacy Practice Certificate (specified in Clause 2, Article 33 of the Law on Pharmacy)" under the condition: "For establishments providing drug and pharmaceutical ingredient preservation services: The person responsible for pharmaceutical expertise and the job position specified in Article 11 of the Law on Pharmacy must have a Pharmacy Practice Certificate appropriate to the pharmaceutical business establishment specified in Clause 2, Article 32 of the Law on Pharmacy".

Reducing the conditions for establishments providing drug and drug ingredient storage services: in the case of delivery and receipt of radioactive drugs, the deliverer and recipient of radioactive drugs must have an additional radiation safety certificate according to regulations of the Ministry of Science and Technology (stipulated in Clause 1, Article 33 of Decree No. 163/2025/ND-CP).

Reducing conditions for establishments providing drug and drug ingredient storage services: Establishments participating in the process of delivering and receiving radioactive drugs must have a license to conduct radiation work within the scope of transporting radioactive sources according to regulations of the Ministry of Science and Technology (stipulated in Clause 5, Article 33 of Decree No. 163/2025/ND-CP).

The Decision also simplifies the issuance/re-issuance and adjustment of certificates of eligibility for pharmaceutical business under the authority of the Department of Health for drug and pharmaceutical ingredient wholesale establishments; drug retail establishments including pharmacies, drug counters, medicine cabinets of commune health stations, establishments specializing in retailing medicinal herbs, herbal medicines, and traditional medicines).

Specifically: Remove the regulation "job positions specified in Article 11 of the Law on Pharmacy must have a Pharmacy Practice Certificate (specified in Clause 2, Article 33 of the Law on Pharmacy)" under the condition: "For drug and pharmaceutical ingredient wholesale establishments: The person responsible for pharmaceutical expertise and job positions specified in Article 11 of the Law on Pharmacy must have a Pharmacy Practice Certificate appropriate to the pharmaceutical business establishment specified in Clause 2, Article 32 of the Law on Pharmacy".

Reduce the conditions for wholesale establishments of drugs and pharmaceutical ingredients when delivering and receiving radioactive drugs. The deliverer and recipient of radioactive drugs must have an additional radiation safety certificate according to regulations of the Ministry of Science and Technology (stipulated in Clause 1, Article 33 of Decree No. 163/2025/ND-CP).

Reducing conditions for wholesale establishments of drugs and pharmaceutical ingredients: In case of transporting radioactive drugs, the transporter must also bring a radiation safety certificate (stipulated in Clause 2, Article 33 of Decree No. 163/2025/ND-CP).

Reducing the conditions for importing drugs and pharmaceutical ingredients: In case of transporting radioactive drugs, radiation safety must be ensured in accordance with the regulations on safe transportation of radioactive materials issued by the Minister of Science and Technology (stipulated in Clause 4, Article 33 of Decree No. 163/2025/ND-CP).

Reducing conditions for wholesale establishments of drugs and pharmaceutical ingredients: Establishments participating in the process of delivering and receiving radioactive drugs must have a license to conduct radiation work within the scope of transporting radioactive sources according to regulations of the Ministry of Science and Technology (stipulated in Clause 5, Article 33 of Decree No. 163/2025/ND-CP).

Remove the provision that "the job position specified in Article 11 of the Law on Pharmacy must have a Pharmacy Practice Certificate (specified in Clause 2, Article 33 of the Law on Pharmacy)" under the condition: "For drug retail establishments: The person responsible for pharmaceutical expertise and the job position specified in Article 11 of the Law on Pharmacy must have a Pharmacy Practice Certificate appropriate to the pharmaceutical business establishment specified in Clause 2, Article 32 of the Law on Pharmacy".

Reduce the conditions for drug retail establishments when delivering and receiving radioactive drugs. The deliverer and recipient of radioactive drugs must have an additional radiation safety certificate according to regulations of the Ministry of Science and Technology (stipulated in Clause 1, Article 33 of Decree No. 163/2025/ND-CP).

Reducing conditions for establishments providing drug and drug ingredient storage services: Establishments participating in the process of delivering and receiving radioactive drugs must have a license to conduct radiation work within the scope of transporting radioactive sources according to regulations of the Ministry of Science and Technology (stipulated in Clause 5, Article 33 of Decree No. 163/2025/ND-CP).

Reducing the conditions for retail establishments selling drugs on the List of restricted retail drugs must meet all the conditions specified in Point d, Clause 1, Article 33 of the Law on Pharmacy.

Regarding the notification of mobile drug retail activities, the Decision also reduces the condition that mobile retail drugs must have a minimum expiry date of 6 months (stipulated in Clause 3, Article 26 of Decree No. 163/2025/ND-CP).

Simplify conditions on human resources, facilities, and quality management systems in cosmetics production.

For the cosmetics manufacturing sector, the Decision reduces and simplifies the issuance/re-issuance/adjustment of Certificates of eligibility for cosmetics manufacturing.

Specifically as follows: Simplify the personnel conditions: from "the person in charge of production of the facility must have specialized knowledge in one of the following fields: chemistry, biology, pharmacy or other related fields that meet the requirements of the job" to "the person in charge of production of the facility must have specialized knowledge in one of the following fields: chemistry, biology, pharmacy."

Simplify the conditions on facilities: from "requirement to have location, area, factory, equipment meeting the requirements on production line, type of cosmetic products" to "requirement to have location, area, factory, equipment meeting the requirements on production line".

Reduce the Quality Management System requirement that requires quality inspection of packaged products.

This Decision comes into force from the date of signing and promulgation (September 22, 2025).

Source: https://baotintuc.vn/chinh-sach-va-cuoc-song/don-gian-hoa-nhieu-thu-tuc-hanh-chinh-trong-kinh-doanh-duoc-san-xuat-my-pham-20250923182547921.htm