Guidelines on Applications for Registration of Vaccines and Other Biological Products for Human and Veterinary Use Pays/Territoire Zambie Type du document Miscellaneous Date 2008 Source FAO, FAOLEX Sujet Bétail, Général Mot clé Médicaments Vaccination Santé publique Restrictions à l'utilisation Commerce intérieur Normes Transformation/manutention Enregistrement Hygiène/procédures sanitaires Questions de procédures Mise en application Autorisation/permis Santé des animaux Aire géographique Afrique, Afrique Orientale, Nations en développement sans littoral, Pays les moins avances Résumé 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. Texte intégral Anglais Site web zgfoffce.org