Good Distribution Practice for Pharmaceutical Products Regulations, 2021 - S.I. no. 72 of 2021.

These Regulations, made under sections 5 and 30 of the National Agency for Food and Drug Administration and Control Act (Cap. N1 LFN) 2004 and section 12 of the Food, Drug and Related Products (Registration, etc.) Act (Cap. F33 LFN) 2004, prescribe the minimum requirements for good distribution practice in the public and private sectors for finished pharmaceutical products. According to the text of the Regulations, pharmaceutical products mean any substance or combination of substances used to treat human being and animal diseases and to restore their physiological functions and include medicines, vaccines, herbal medicines, biologicals, medical devices, disinfectants and diagnostics. The Regulations apply to individuals involved in goods distribution and governments at each level, public and private health institutions, importers, exporters, transporters, distributors and wholesalers of pharmaceutical goods. Matters covered by the Regulations concern: authorisation to distribute the products; inspection; documentation and record keeping; storage and transport conditions; shipment containers and container labelling; quarantine conditions; offences and penalties; interpretation of relevant terms.