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

Pays/Territoire
Nigéria
Type du document
Règlement
Date
2021
Source
FAO, FAOLEX
Source d'origine
Federal Republic of Nigeria Official Gazette no. 131 of 2021.
Sujet
Bétail, Alimentation et nutrition, Plantes cultivées
Mot clé
Contrôle de qualité alimentaire/innocuité des produits alimentaires Toxicité/empoisonnement Emballage/étiquetage Médicaments Santé des animaux Enregistrement Pesticides
Aire géographique
Afrique, Atlantique Nord, Afrique de l'Ouest
Résumé

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.

Texte intégral
Anglais
Site web
www.nafdac.gov.ng

Références - Législation

Implemente

National Agency for Food and Drug Administration and Control Act.

Législation | Nigéria | 1993 (2004)

Mot clé: Législation de base, Contrôle de qualité alimentaire/innocuité des produits alimentaires, Hygiène/procédures sanitaires, Institution, Inspection, Commerce international, Médicaments, Santé des animaux

Source: FAO, FAOLEX

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

Législation | Nigéria | 1993 (2004)

Mot clé: Contrôle de qualité alimentaire/innocuité des produits alimentaires, Toxicité/empoisonnement, Commerce international, Commerce intérieur, Enregistrement, Inspection, Eau minérale, Infractions/sanctions, Médicaments, Aliments pour animaux, Santé des animaux, Approvisionnement en eau, Eau potable

Source: FAO, FAOLEX