Decision No. 357/QD-QLD issues domestic production registration numbers for five types of medicines that have been permitted to circulate in Vietnam, applicable to manufacturing companies and health management agencies.
Đối tượng áp dụng
Southern Pharmaceutical Joint Stock Company, OPC Pharmaceutical Joint Stock Company, Dong Nai Pharmaceutical Joint Stock Company
Các điểm cốt lõi
- Southern Pharmaceutical Joint Stock Company → is issued the production registration number VS-4853-12 for the vaginal wash medicine FRAGYNA
- OPC Pharmaceutical Joint Stock Company → is issued the production registration numbers VS-4854-12, VS-4855-12, and VS-4856-12 for Alcool 70°, Alcool 90°, and Gynonew-OPC respectively
- Dong Nai Pharmaceutical Joint Stock Company → is issued the production registration number VS-4857-12 for LADYPRESH
- The companies → must print the registration number on the drug label and comply with relevant regulations
- The registration number is valid for 05 years from the date of signing the decision
🌐 Tác động xã hội từ văn bản này
- Positive: Helps pharmaceutical enterprises produce drugs according to regulations, ensuring quality and safety for users.
- Negative: May cause administrative procedure difficulties for companies when printing the registration number on the drug label.
❓ Câu hỏi thường gặp
Which company is granted the registration number?
Southern Pharmaceutical Joint Stock Company, OPC Pharmaceutical Joint Stock Company, and Dong Nai Pharmaceutical Joint Stock Company are granted production registration numbers for various types of medicines.
How long is the registration number valid?
The registration number is valid for 05 years from the date of signing the decision.
What must the company do with the registration number?
The company must print the registration number on the drug label and comply with relevant regulations related to the production and circulation of drugs.
When does this decision take effect?
This decision takes effect from the date of issuance, specifically December 26, 2012.
What should drug manufacturing companies pay attention to?
Companies must print the registration number on the drug label and comply with relevant regulations related to the production and circulation of drugs, and the registration number is valid for 05 years from the date of signing the decision.
Toàn văn
Pursuant to …;
Regarding the issuance of domestic production registration numbers for five drugs permitted to circulate in Vietnam
_______________________
DIRECTOR OF THE DRUG MANAGEMENT AGENCY
Pursuant to the Drug Law dated June 14, 2005;
Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decision No. 53/2008/QĐ-BYT dated December 30, 2008 of the Minister of Health stipulating the functions, tasks, powers, and organizational structure of the Drug Management Agency under the Ministry of Health and Decision No. 3106/QĐ-BYT dated August 29, 2011 of the Minister of Health amending and supplementing Clause 3 of Decision No. 53/2008/QĐ-BYT dated December 30, 2008 of the Minister of Health stipulating the functions, tasks, powers, and organizational structure of the Drug Management Agency under the Ministry of Health;
Pursuant to Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on drug registration;
Pursuant to the letter No. 2447/SYT-NVD dated November 12, 2012 of the Can Tho Department of Health, the letter No. 1031/SYT-QLD dated August 1, 2012 and the letter No. 1463/SYT-QLD dated October 11, 2012 of the Binh Duong Department of Health, and the letter No. 3226/SYT-NVD dated November 12, 2012 of the Dong Nai Department of Health regarding the request for registration numbers for external-use drugs listed in Appendix V of Circular No. 22/2009/TT-BYT;
Considering the proposal of the Head of the Drug Registration Department - Drug Management Agency,
DECISION:
Article 1. Issuing domestic production registration numbers for five drugs permitted to circulate in Vietnam:
1. Registration and production entity: Southern Pharmaceutical Joint Stock Company
No. 300C, Nguyen Thong Street, An Thoi Ward, Binh Thuy District, Can Tho City.
|
Serial number |
Drug name, dosage form |
Packaging specification |
Basic standard |
Shelf life (months) |
Registration number |
|
1 |
External genital wash FRAGYNA (Copper sulfate 0.0025g/ml) |
Bottle 90ml, bottle 250ml solution for external use |
TCCS |
18 |
VS-4853-12 |
2. Registration entity: OPC Pharmaceutical Joint Stock Company
No. 1017 Hong Bang Street, District 6, Ho Chi Minh City
Production entity: OPC Pharmaceutical Joint Stock Company Branch in Binh Duong - OPC Pharmaceutical Factory
Tan Hoa Commune, Tan Vinh Hiep District, Binh Duong Province.
|
2 |
Alcohol 70° (Ethanol 96% 43.75ml/60ml) |
Bottle 60ml, bottle 90ml solution for external use |
TCCS |
36 |
VS-4854-12 |
|
3 |
Alcohol 90° (Ethanol 96% 0.9375ml/ml) |
Bottle 60ml, bottle 90ml solution for external use |
TCCS |
36 |
VS-4855-12 |
|
4 |
Gynonew-OPC (1 ml solution containing: Tea tree oil 0.01g, Sodium lauryl ether sulfate 0.08g, Panthenol (Provitamin B5) 0.01g) |
Bottle 30ml, bottle 100ml solution for vaginal washing |
TCCS |
36 |
VS-4856-12 |
3. Registration and production entity: Dong Nai Pharmaceutical Joint Stock Company
No. 221B Pham Van Thuan Street, Tan Tien Ward, Bien Hoa City, Dong Nai Province.
|
5 |
LADYPRESH (Alpha-terpineol 0.01g/ml) |
Box 1 bottle 80ml, box 1 bottle 200ml, box 1 bottle 250ml solution for vaginal washing |
TCCS |
36 |
VS-4857-12 |
Article 2. The company must print the registration number issued by the Ministry of Health on the drug label and comply with all relevant regulations concerning drug production and circulation. The registration number with the VS-...-12 code is valid for five years from the date of issuance of this decision.
Article 3. This Decision takes effect from the date of issuance.
Article 4. Directors of health departments of provinces and centrally governed cities and directors of entities mentioned in Article 1 are responsible for implementing this Decision.
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