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Good Manufacturing Practice for Medicinal Products Regulations, 2021 - S.I. no. 73 of 2021.

Country/Territory
Nigeria
Document type
Regulation
Date
2021
Source
FAO, FAOLEX
Original source
Federal Republic of Nigeria Official Gazette no. 148 of 2021.
Subject
Livestock
Keyword
Animal health Education Processing/handling Inspection Packaging/labelling Public health Hygiene/sanitary procedures Offences/penalties Transport/storage Drugs
Geographical area
Africa, North Atlantic, Western Africa
Abstract

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.

Full text
English
Website
www.nafdac.gov.ng

References - Legislation

Implements

National Agency for Food and Drug Administration and Control Act.

Legislation | Nigeria | 1993 (2004)

Keyword: Basic legislation, Food quality control/food safety, Hygiene/sanitary procedures, Institution, Inspection, International trade, Drugs, Animal health

Source: FAO, FAOLEX

Food, Drugs and Related Products (Registration, etc.) Act.

Legislation | Nigeria | 1993 (2004)

Keyword: Food quality control/food safety, Toxicity/poisoning, International trade, Internal trade, Registration, Inspection, Mineral water, Offences/penalties, Drugs, Animal feed/feedstuffs, Animal health, Water supply, Potable water

Source: FAO, FAOLEX