Transcription of DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)
Drug REGISTRATION GUIDANCE DOCUMENT (DRGD) DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) NATIONAL PHARMACEUTICAL REGULATORY DIVISION MINISTRY OF HEALTH, MALAYSIA Second Edition September 2016, revised January 2019 Please visit the NPRA website for the latest updates Address: Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor Darul Ehsan, Malaysia + 603-7883 5400 + 603-7956 2924, 7956 7075 Certified to ISO 9001:2015 Cert. No. : QMS 00894 Drug REGISTRATION GUIDANCE DOCUMENT (DRGD) National Pharmaceutical Regulatory Division, Ministry of Health Malaysia. Second Edition, September 2016, Revised January 2019 2 GUIDELINE HISTORY No. Guideline Description of Amendment Effective date 1. a) Guidelines for Application for REGISTRATION of Pharmaceutical Products, Third Edition b) Permohonan Pendaftaran Keluaran Ubat Tradisional, Second Edition Initial Publication a) October 1993 b) December 1998 2.
CEP is referring to Certificate of Suitability of European Pharmacopoeia monographs issued by the EDQM CFC Chlorofluorocarbons CFS Certificate of Free Sales CI Confidence Interval CMC Chemistry, Manufacturing And Controls CoA Certificate of Analysis COH Change of Product Registration Holder (Previously known as Change of
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