Licenses library · 694
Certificate of Registration of International Drug Formula for Domestic Production
国际药品配方国产注册证明
ໃບຢັ້ງຢືນທະບຽນຢາ ຕໍາລາຢາສາກົນທີ່ຜະລິດພາຍໃນປະເທດ
Domestic pharmaceutical factory. Apply at Food and Drugs Department.
Who needs this
Domestic pharmaceutical factory.
Requirements
- For locally manufactured drugs, those who intend to produce drugs must submit an application for the production of a sample drug according to the Application Form
- Once a permit for producing sample drug is granted, the manufacturer shall submit the application for registration Form 2 within 3 to 6 months.
- For imported drugs, those who intend to import drugs from abroad must apply for a permit to import a sample drug according to the Application Form
- Once a permit for importing a sample drug is granted, the manufacturer shall submit the application for registration Form 2 within 3 to 6 months.
Documents — first application
| Document | Note |
|---|---|
| Application Form for Registration (Form No.2) | |
| Certificate of Analysis | indicate the methods and attach documents related to the analysis, 2 sets |
| 须提供译文的文件 | 2 sets |
| Documents or Evidence for the Efficacy of Drugs | information about the clinical trails, 1 set |
| Documents related to Medical Manufacturing | 1 set |
| Study on the Expired Date of the Medicine | |
| Labels and Leaflet of Medicine | 1 set |
| Sample of the Drug for Assessment and Quality Control |
Legal framework
- Law on Drugs and Medical Products (Amended)
- Provision on Medicine Registration
How to submit
- Means of presentation
- At the Authority Offices
- Address of authority
- Food and Drugs Department, Ministry of Public Health
- Processing time
- 0 Pursuant to the regulation on drug registration No. 1441/MOH, the application period is 6 months.
Validity and renewal
- Has an expiry date
- YES
- Validity
- 36 months
- Renewal process
- Pursuant to the Presidential Ordinance No. 003/PO.
Additional comment
Only for the registration of a domestic manufactured drug.