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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.

a) The making or assembling of the product; b) The enclosing or packing of the product in any container in a form suitable for administration or application, and the labelling of the container and; c) The carrying out of any process in the course of any of the foregoing activities. (as defined in Regulation 2, CDCR 1984)

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