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

País/Territorio
Kenya
Tipo de documento
Reglamento
Fecha
2019
Fuente
FAO, FAOLEX
Fuente original
Kenya Gazette Supplement No. 130
Materia
Alimentación y nutrición
Palabra clave
Autorización/permiso Protección del consumidor Medicamentos Higiene/procedimientos sanitarios Inspección Comercio interior Comercio internacional Envasado/etiquetado Infracciones/sanciones Rastreabilidad/rastreo de productos Registro Control de calidad de los alimentos/inocuidad de los alimentos
Área geográphica
Africa, Africa Oriental
Resumen

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.

Texto completo
Inglés

Referencias - Legislación

Implementa

Pharmacy and Poisons Act (Cap. 244).

Legislación | Kenya | 1957 (2002)

Palabra clave: Legislación básica, Sanidad animal, Medicamentos, Autorización/permiso, Comercio interior, Comercio internacional, Plaguicidas, Registro, Sustancias peligrosas

Fuente: FAO, FAOLEX