DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)5.6 CLINICAL TRIAL IMPORT LICENCE (CTIL)/ CLINICALTRIAL EXEMPTION (CTX)For more information pertaining to any matters of clinical trial, please refer to NPCBwebsite.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 64
Drug Registration Guidance Document (DRGD)6. GENERAL CONDITIONS FOR REGISTRATION OFDRUG PRODUCTS UNDER THE CONTROL OFDRUGS AND COSMETICS REGULATIONS 19846.1 REGISTRATION NUMBERThe product registered with the Registration Number as stated in the RegistrationCertificate shall have the name, composition, characteristics, specifications andorigin as specified in the registration documents.6.2 PRODUCT PARTICULARThe holder of the registration certificate shall supply such documents, items,samples, particulars or information as the Authority may require in relation to theregistered product.No change in name, composition, characteristics, origin, specifications,manufacturer, packing, indications, labeling, package insert, product literature or anyrelevant particulars of the registered product shall be made without prior approval ofthe Authority.6.3 LABELLINGThe registered product shall be labeled with the Registration Number. The labels forthe registered product shall comply with all other labeling requirements specified bythe Authority.6.4 PRODUCT AUTHENTICATIONThe registered product shall be affixed with the security device approved by theAuthority. The said security device (hologram), which is serialized, shall be used toauthenticate and verify that the product is registered with the Authority, and will beaffixed to each unit pack of the product, whether locally manufactured or imported.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 panelNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 65
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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