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Pharmacy and Poisons (Parallel Imported Medicinal Substances) Rules, 2019- No. 130 of 2019

Pays/Territoire
Kenya
Type du document
Règlement
Date
2019
Source
FAO, FAOLEX
Source d'origine
Kenya Gazette Supplement No. 130
Sujet
Alimentation et nutrition
Mot clé
Autorisation/permis Protection du consommateur Médicaments Hygiène/procédures sanitaires Inspection Commerce intérieur Commerce international Emballage/étiquetage Infractions/sanctions Traçabilité/traçage du produit Enregistrement Contrôle de qualité alimentaire/innocuité des produits alimentaires
Aire géographique
Afrique, Afrique Orientale
Résumé

These Regulations are made pursuant to the Pharmacy and Poisons Act. The Rules apply to medicinal substances which are parallel imported and distributed on the Kenyan market, with well specified exceptions. The Regulations provide that a person shall not import a medicinal substance unless the person is incorporated as a limited liability company. Additional requirements include that the person has a certificate of parallel importation to import the medicinal substance, that the substance has a valid registration in Kenya and the substance has a valid market authorization in its country of origin. The Rules provide extensively for the procedure for the application of the certificate of parallel importation and the parallel import licence. The Rules further provide for the packaging and labeling of the imported items and provides for the power of authorized officers to carry out the inspection of premises and consignments of medicinal substances at the port of entry.

Texte intégral
Anglais

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