Good Manufacturing Practice for Medicinal Products Regulations, 2021 - S.I. no. 73 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 good manufacturing practice requirements for processing, packaging or handling of a pharmaceutical product for human or animal use, in order to ensure that the product meets safety requirements, and quality and purity characteristic requested. 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 or to prevent diseases. Matters covered by these Regulations include: definition of pharmaceutical quality system; education, training and requested experience for qualified personnel; building and premises requirements; materials management; good manufacturing and distribution practices; labelling and packaging requirements; quality control; procedures relating to health and hygienic practices; complaint and product recall; offences and penalties; interpretation of relevant terms.