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National Drug Policy and Authority (Pharmacovigilance) Regulations, 2014 (S.I. No. 37 of 2014).

Pays/Territoire
Ouganda
Type du document
Règlement
Date
2014
Source
FAO, FAOLEX
Source d'origine
Supplement No. 8 to The Uganda Gazette No. 18 of 28 March 2014.
Sujet
Bétail, Alimentation et nutrition
Mot clé
Santé publique Santé des animaux Médicaments Inspection Autorisation/permis Collecte de données/déclarations Infractions/sanctions
Aire géographique
Afrique, Afrique Orientale, Nations en développement sans littoral, Pays les moins avances
Résumé

These Regulations, made by the Minister responsible for health under section 64 of the National Drug Policy and Authority Act, and on the advice of the National Drug Authority, provide with respect to a pharmacovigilance system and the reporting of and investigation of counterfeit drugs. “Pharmacovilance” means the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem. A licensed person shall have an appropriate system for pharmacovigilance, to manage the safety of the data for the drugs for which the licensed person is responsible. Where the National Drugs Authority determines that a drug may not be safe to use, the Authority shall request a licensed person to submit to the Authority— (a) a periodic safety update report; and (b) any other reports that may be relevant to determine the safety, efficacy and quality of the drug, as the Authority may determine. A report shall be submitted using the format in the Schedule to these Regulations, for human drugs or veterinary drugs, respectively.

Texte intégral
Anglais
Site web
www.nda.or.ug

Références - Législation

Implemente

National Drug Policy and Authority Act 1993 (Ch 206) .

Législation | Ouganda | 1993

Mot clé: Hygiène/procédures sanitaires, Transport/dépôt, Toxicité/empoisonnement, Santé publique, Contrôle de qualité alimentaire/innocuité des produits alimentaires, Santé des animaux, Médicaments, Aliments pour animaux, Normes

Source: FAO, FAOLEX