NAFDAC Good Distribution Practices Guidelines For Pharmaceutical Products, 2016 - Nigeria
(2016; 57 pages)

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The distribution of pharmaceutical products is an important activity in the supply chain and involves several players. It consists of procuring, holding, supplying, importing and exporting of pharmaceutical products. Distribution activities are carried out by manufacturers, importers, wholesalers/distributors, retailers and other persons authorized to supply pharmaceutical products in the public and private sectors.

The Good Distribution Practice (GDP) guidelines are intended to help distributors of pharmaceutical products comply with NAFDAC Good Distribution Practice Regulations. The GDP regulations prescribe the minimum requirements for good distribution practice for pharmaceutical products. The GDP guidelines provide appropriate tools to assist all categories of distributors in conducting their activities in order to maintain the quality of pharmaceutical products and prevent counterfeit products from entering the legal supply chain. They are intended to help in minimizing the inherent risks in distribution such as mix-ups, adulteration, contamination and cross-contamination.

These guidelines apply to all persons and entities involved in any aspect of the distribution of pharmaceutical products from the manufacturing site to the point of sale or use. The guidelines apply but are not limited to governments at all levels, non-governmental organisations, public and private health and storage facilities, manufacturers of finished pharmaceutical products, importers, exporters, wholesalers/distributors, suppliers, pharmacy retailers.

Some sections of these guidelines also apply to other entities involved in the distribution of pharmaceutical products such as forwarding agents, freighters and transporters. The guidelines also apply to distributors that are established or operating in specific customs areas, such as free zones or free warehouses. The guidelines do not apply to holders of Patent and Proprietary Medicine Vendors' License (PPMVL) as the activities of this group are covered under Good Dispensing Practices.

This document is to be used in conjunction with other existing relevant pharmaceutical product statutes in the country. The good practices outlined below are to be considered general guides, and they may be adapted to meet individual needs as long as the distributor achieves compliance with regulatory objectives.

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