DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)5.4.2 GOOD MANUFACTURING PRACTICE (GMP) CERTIFICATEAccording to the CDCR 1984, compliance to Good Manufacturing Practice (GMP) isprerequisite to application of a manufacturing license, as well as product registration/cosmetic notification.GMP is a standard which shall be followed by the manufacturers to ensure that theproducts manufactured are safe, efficacious and of quality.Upon complete application, a GMP certificate will be issued and a fee, as stated inAppendix 1: Fees, is payable on the issue of such certification.If a manufacturer who wishes to build a new manufacturing premise, themanufacturer may submit a proposed premise layout plan to the Centre forCompliance and Licensing, NPCB for evaluation.For more information, please refer Section D: 13.4 GMP Certificate and/or NPCBwebsite.5.5 LICENSESNote:In addition to the relevant laws and regulations as stated in this DRGD,manufacturers are required to comply with the principles of Good ManufacturingPractice (GMP) and Good Distribution Practice (GDP). Meanwhile, Importers andWholesalers are required to comply with the principles of Good Distribution Practice(GDP).According to the CDCR 1984, any company who wishes to manufacture, import and/orwholesale any registered products needs to have Manufacturer‟s Licence, Import Licenceand/or Wholesaler‟s License.For more information pertaining application of appropriate licences, please refer Section D:13. Licensing or contact Licensing Unit, Centre for Compliance and Licensing (CCL), NPCBor NPCB website.As for processing fee for these applications, please refer to Appendix 1: FeesNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 64
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 | 65
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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