Drug Registration Guidance Document, April 2011 Revision
(2011; 231 pages)


This “Drug Registration Guidance Document” will serve as the reference guide for both pharmaceutical products for human use and traditional products. Regulation 7(1)(a) of the Control of Drugs and Cosmetics (Amendment) Regulations 2006 requires all products to be registered with the DCA prior to being manufactured, sold, supplied, imported or possessed or administered, unless the product is exempted under the specific provisions of the Regulations. The guidelines outlined in this document are primarily drawn up in accordance to the legal requirements of the Sale of Drugs Act 1952 and the Control of Drugs and Cosmetics Regulations 1984.

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