DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)License/ Import License and a copy of approval letter from the Authority (The Authority‟smeeting result).3. The application of additional list shall be submitted by filling Borang BPFK-413TApplication for (Additional) Product List of License for Registered Product.13.4 GMP CERTIFICATE1. GMP certificates are issued for the purpose of exportation of locally manufacturedregistered products. It endorses that the local manufacturer complies with the currentGMP requirements. These certificates are required by the overseas regulatory agenciesfor products registration in their countries. Thus, when filling in the GMP certificateapplication form, the correct address of the overseas regulatory agencies given by thecompany is crucial.2. The application of GMP Certificate shall be submitted by filling Borang BPFK-420Permohonan Sijil Amalan Perkilangan Baik (APB).3. A fee of RM50.00 is payable on the issue of such certification.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 103