DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)If yes, please attach the related document.Applicants who hold valid patents shall provide documentary evidence of thenature and extent of their patents.f) Certificate of Pharmaceutical Product (CPP), Certificate of Free Sale (CFS)and Certificate of Good Manufacturing Practice (GMP)Please attach the certificates.Please key in issuing body, date of issue, date of expiry of the certificates. Ifthe issuing body is not listed, please select „Not Listed‟ button. Automaticemail will be sent to NPCB for verification.The certificates shall be valid and current at the time of submission.For imported products, the following requirements shall be furnished, either a:i) CPP from the competent authority in the country of origin; OR(Note: In the event a CPP is not available from the country manufacture,e.g. where a product is not licensed for sale in said country because itsmanufacturer is manufacturing under contract only for product owner fromanother country, the following alternatives may be considered: GMPCertification/ Manufacturing License for the manufacturer from the relevantcompetent authority, together with CPP from the country of the productowner; or CPP from country of release, if CPP from the country of theproduct owner is not available)ii) CFS and GMP from the relevant competent authorities is deemedacceptable by the Authority for health supplements and natural productsonly.CPP shall be in the format of the WHO Certification Scheme on the Quality ofPharmaceutical Products Moving in International Commerce & be issued bythe Health Authorities listed in the WHO Certification Scheme (list is availablefrom WHO website: http://www.who.int).CPP which is issued by EMA for products registered through the centralizedprocedure in EU will be accepted.CPP issued by the manufacturer or other authorities are not acceptable.If more than one manufacturer is involved in the manufacture of a product,GMP certification shall be available for all the manufacturers.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 450
Drug Registration Guidance Document (<strong>DRGD</strong>)The Authority reserves the right to conduct an inspection on anymanufacturing site.Unless otherwise supported by justifications acceptable to the Authority, thefollowing products are unlikely to be registered:i) products not licensed/ certified for sale in the country of manufacture/product owner;ii) products manufactured for export only (imported products).g) Is this product licensed to be placed on the market for use in the exportingcountry?If no, please state the reason.h) Is the product on the market in the exporting country?If no, please state the reason.i) Summary of Product Characteristics (SPC)Please attach (where applicable).j) Patient Information Leaflet (PIL)Please attach (where applicable).k) Attachment of Protocol Analysis, Analytical ValidationPlease attach (where applicable).l) Certificate of Analysis (CoA) for Finished ProductFor two (2) batches.Compulsory for imported product.Please attach the certificate (which must be complete with the productspecification and results).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 451
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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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