DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)8.5 REGULATORY OUTCOME8.5.1 DECISIONS OF THE AUTHORITYA regulatory decision shall be made based on the outcome of the evaluation of thesubmitted documentation, and samples (if applicable). An application may beapproved or rejected by the Authority, and the Authority decision will be sent viaemail/ official letter to the product registration holder.As stipulated under the CDCR 1984, Regulation 11(1), the Authority may, at anytime reject, as well as cancel or suspend the registration of any product if there aredeficiencies in safety, quality or efficacy of the product or failure to comply withconditions of registration.8.5.2 PRODUCT REGISTRATION NUMBERAs stipulated in Regulation 8(8), CDCR 1984, upon registration of a product by theAuthority, the product registration holder shall be notified by the Authority and aproduct registration number (i.e. MAL number) shall be assigned to the registeredproduct via the system.The registration number is specific for the product registered with the name, identity,composition, characteristics, origin (manufacturer) and product registration holder,as specified in the registration documents. It shall NOT be used for any otherproduct.8.5.3 CERTIFICATE OF REGISTRATIONForm 1 (Certificate of Registration) for a product with the provisions, conditions,limitations and etc. of the registration, as stipulated in Regulation 8(8) of CDCR1984, has been deleted from the regulation in year 2006 via amendment of PU(A)336/06. Therefore, the certificate will no longer be issued by the Authority.Applicant shall refer to the product registration approval notification sent by theAuthority or the Approved Product Registration List in NPCB website.Reference: Circular (100)dlm.BPFK/PPP/01/03 Jld. 2National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 81