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The Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, Legal Notice no. 100 of 2022.

Pays/Territoire
Kenya
Type du document
Règlement
Date
2022
Source
FAO, FAOLEX
Source d'origine
Kenya Subsidiary Legislation, 2022.
Sujet
Bétail, Plantes cultivées
Mot clé
Santé des animaux Autorisation/permis Emballage/étiquetage Santé publique Enregistrement Vaccination Médicaments Production végétale
Aire géographique
Afrique, Afrique Orientale
Résumé

These Rules, made in exercise of the power conferred by section 44(1) of the Pharmacy and Poisons Act (cap. 244) of 1957, provide for control of import, manufacturing and selling of a health product or technology. The Rules concern: good manufacturing practice certificate; immunogenic substance; medicinal product and medicinal substance, whose origin may be human, animal, vegetable or chemical and includes animals, animal secretions, part of plants, vegetable secretions; vaccine. Matters covered by these Rules include: application for registration of health product and technology, accompanied by: a proposed label for use on the health product, a copy of a certificate of analysis from a quality control laboratory, a copy of the marketing authorisation, available data on the quality, safety, efficacy and performance of the health product or technology, a valid licence to deal in poisons for mining or agricultural purposes; specific information to be provided on the products; validity and renewal of a certificate of registration; change in the product details; provisional certificate of registration in case of a threat to human or animal life or health; procedure for authorisation of unregistered health product or technology, including human or animal pharmacological and clinical data related to the health product; specific measures in case the safety of any patient or animal is compromised, including withdrawal of the authorisation.

Texte intégral
Anglais
Site web
www.kenyalaw.org

Références - Législation

Implemente

Pharmacy and Poisons Act (Cap. 244).

Législation | Kenya | 1957 (2002)

Mot clé: Législation de base, Santé des animaux, Médicaments, Autorisation/permis, Commerce intérieur, Commerce international, Pesticides, Enregistrement, Substances dangereuses

Source: FAO, FAOLEX

Abroge

Pharmacy and Poison (Registration of Drugs) Rules (Cap. 244).

Législation | Kenya | 1981 (2012)

Mot clé: Santé des animaux, Médicaments, Enregistrement, Commerce international, Inspection, Pesticides, Substances dangereuses

Source: FAO, FAOLEX