Articles
Drug registration guideline
THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
PART I : ADMINISTRATIVE DATA AND PRODUCT INFORMATION
| 1. | Application Form |
| 2. | Letter of Authorisation |
| 3. | Certification |
| 3.1 |
For contract manufacturing (a) License of pharmaceutical industries and contract manufacturer (b) Contract manufacturing agreement (c) GMP certificate of contract manufacturer |
| 3.2 |
For manufacturing “ under- license ” (country specific) (a) License of pharmaceutical industries (b) GMP certificate of manufacturer (c) Copy of “ under-license” agreement |
| 3.3 |
For imported products (a) License of pharmaceutical industries/ importerl wholesaler(country specific) (b) Certificate of Pharmaceutical Product issued by the competent authority in the (c) Site master file of manufacturer (unless previously submitted within the last 2yea'rs) |
| 4 |
Labelling |
| 4.1 |
Unit Carton |