DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)product 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. 28.6 POST-REGISTRATION PROCESSRegistration status of a product shall be valid for five (5) years or such period as specifiedin the registration certificate (unless the registration is suspended or cancelled by theAuthority).Upon approval for product registration by the Authority, applicants shall fulfill allcommitments and conditions imposed during approval of the product registration and shallbe responsible for the maintenance of the product in terms of quality, safety and efficacythroughout the validity period of registration. Failure to do so may result in rejection ofapplication for renewal of product registration.The Authority shall be notified of any changes to the product‟s efficacy, quality and safety,as described in detail at Section E: Post-Registration Process.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 81