Licenses library · 692
Permit to Produce Sample Drug for Domestic Drug Formula Registration
国产药品注册用样品生产许可
ໃບອະນຸຍາດຜະລິດຢາຕົວຢ່າງ ເພື່ອຂື້ນທະບຽນຕຳລາຢາຜະລິດພາຍໃນ
Domestic drugs manufacturer. Apply at Food and Drugs Department.
Who needs this
Domestic drugs manufacturer.
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 | |
| Drugs Labels of all Packing Sizes | 2 sets |
| Documents on Drug Management |
Legal framework
- Law on Drugs and Medical Products (Amended)
- Provision on Medicine Registration
How to submit
- Address of authority
- Food and Drugs Department, Ministry of Public Health
- Processing time
- 0 Pursuant to the Regulation on Drug Registration 1441/MOH, the application period is 3 months.
Validity and renewal
- Has an expiry date
- YES
- Validity
- 6 months
- Renewal process
- Pursuant to the Regulation on Drug Registration 1441/MOH