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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.

Regulation 2, CDCR 1984) Licensed Wholesaler: A person to whom a wholesaler's licence has been issued Regulation 12, CDCR 1984 (as defined in Regulation 2, CDCR 1984) Manufacturer: A person carrying out one or more of the steps specified in the definition of manufacture. Manufacture, in relation to any product includes –

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