DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)of 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 may be affixed onthe product label;b) FAQ no. 20 on hologram, for details; andc) Circulars pertaining to hologram and the latest directive Hologram Meditag III.6.5 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.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no longer authorized to be theholder of the registration certificate.Upon withdrawal, the registration certificate is no longer valid.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 67