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Drugs and Related Products (Registration) Regulations, 2021. S.I. no. 64 of 2021.

Country/Territory
Nigeria
Document type
Regulation
Date
2021
Source
FAO, FAOLEX
Original source
Federal Republic of Nigeria Official Gazette no. 131 of 2021.
Subject
Livestock, Food & nutrition, Cultivated plants
Keyword
Food quality control/food safety Toxicity/poisoning Packaging/labelling Drugs Animal health Registration Pesticides
Geographical area
Africa, North Atlantic, Western Africa
Abstract

These Regulations make provision for the registration of drugs. "Drug" includes any substances of vegetable, animal or mineral origin or any preparation or admixture thereof manufactured, sold or advertised for use in: i) the diagnosis, treatment, mitigation, in man or animal; ii) restoring, correcting or modifying organic function in man and animal; iii) disinfections or the control of vermin, insects or pest; contraception. No drug product shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered in accordance with the provisions of these Regulations. Application for the registration of a drug product shall be made to the National Agency for Food and Drug Administration and Control (NAFDAC). Certain changes here listed (or as may be prescribed by the Agency) shall require a new application. No person shall import or manufacture a drug without having a valid Clinical Trial Certificate of Authorization. Application for a clinical trial shall be made to the Agency. Some additional rules concern importaion and placing on the market of drugs and stability testing, shelf life, expiration dating and storage statement of drugs.

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