DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)The security device shall be affixed onto the outer packaging of the product, (or,where there is no outer packaging, on the immediate packaging), on the front panelof the product label. None of the product particulars on the label shall be coveredover by the security device.Please refer to:a) Appendix 9: Labelling Requirements where the security device/ label may beaffixed on the product label;b) FAQ no. 20 on hologram; andc) Circulars and directives pertaining to security label (hologram):i) Bil (32) dlm BPFK/02/5/1.3ii) Bil (36) dlm BPFK/02/5/1.3iii) Bil (62) dlm BPFK/02/5/1.3iv) (88)dlm.BPFK/PPP/01/03 Jilid 2v) (1)dlm.BPFK/PPP/07/25 Jld. 16.5 INDICATIONS, SPECIAL CONDITIONSThe registered product shall only be indicated for use as approved by the Authority.The importation, manufacture, sale and supply of the registered product shall complywith all other specific conditions imposed by the Authority.6.6 ADVERSE REACTIONS, COMPLAINTSThe product registration holder or any person who possesses any registered productshall inform the Senior Director of Pharmaceutical Services immediately of anyadverse reactions arising from the use of the registered product.6.7 HOLDER OF REGISTRATION CERTIFICATEThe holder of the registration certificate shall inform the Authority of any change inhis name or address.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 66
Drug Registration Guidance Document (DRGD)6.8 WITHDRAWAL FROM REGISTRATIONThe holder of the registration certificate shall notify the Authority with regards to anydecision to withdraw registration of a product and shall state reasons for thedecision.The holder shall also notify the Authority when he is no longer authorized to be theholder of the registration certificate.Upon withdrawal, the registration certificate is no longer valid.6.9 CANCELLATION, SUSPENSION, AMENDMENT BYTHE AUTHORITYThe Authority may, at any time and without assigning any reason suspend or cancelthe registration of any product, and may amend the conditions of registration. Theholder of the registration certificate shall immediately surrender to the Authority theregistration certificate upon cancellation or suspension of the registration of theproduct.The Authority may, at any time and without assigning any reason suspend or cancelthe registration of any product, and may amend the conditions of registration, uponwhich the registration certificate is no longer valid.6.10 DIRECTIVESThe Senior Director of Pharmaceutical Services may issue written directives orguidelines to any person or a group of persons as he think necessary for the bettercarrying out of the provisions of these Regulations and which in particular relate to:a) Product quality, safety and efficacy;b) Labeling;c) Change of particulars of a product;d) Transfer of licenses;e) Manufacturing;f) Storage includes requirements as to containers;g) Retailing;National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 67
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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