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

Country/Territory
Nigeria
Document type
Regulation
Date
2021
Source
FAO, FAOLEX
Original source
Federal Republic of Nigeria Official Gazette no. 147 of 2021.
Subject
Livestock, Cultivated plants
Keyword
Authorization/permit Disinfection/disinfestation Inspection International trade Packaging/labelling Public health Transport/storage Vaccination Drugs Animal health
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 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.

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