Ecolex Logo
El portal del
derecho ambiental
Resultados de la búsqueda » Legislación

Guidelines on Applications for Registration of Vaccines and Other Biological Products for Human and Veterinary Use

País/Territorio
Zambia
Tipo de documento
Miscelanea
Fecha
2008
Fuente
FAO, FAOLEX
Materia
Ganado, General
Palabra clave
Medicamentos Vacunación Salud pública Restricciones para el uso Comercio interior Normas Procesamiento/manipulación Registro Higiene/procedimientos sanitarios Cuestiones de procedimiento Cumplimiento/aplicación Autorización/permiso Sanidad animal
Área geográphica
Africa, Africa Oriental, Naciones en desarrollo sin litoral, Países menos desarrollados
Resumen

These Guidelines provide requirements in support of quality, safety and efficacy in respect of vaccines and other biological medicinal products for human and veterinary use meant to be placed on the Zambian market. One of the means for ensuring that products meet the required standards of quality, safety and efficacy is by conducting product specific pre-marketing assessments to determine whether the product should be registered. Submission of adequate documentation on quality, safety and efficacy of a vaccine and other biological medicinal product will enable the Pharmaceutical Regulatory Authority (PRA) to use the information and other factors to assess the suitability of the product for the intended use. Compliance to these guidelines in the submission of applications will facilitate the speedy processing and evaluation of the applications and subsequent registration of the products. This will enable the product prospective licence holders to market their products on time and make them available to the consumers in a timely manner.

Texto completo
Inglés
Página web
zgfoffce.org