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

Country/Territory
Zambia
Document type
Miscellaneous
Date
2008
Source
FAO, FAOLEX
Subject
Livestock, General
Keyword
Drugs Vaccination Public health Use restrictions Internal trade Standards Processing/handling Registration Hygiene/sanitary procedures Procedural matters Enforcement/compliance Authorization/permit Animal health
Geographical area
Africa, Eastern Africa, Landlocked Developing Nations, Least Developed Countries
Abstract

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.

Full text
English
Website
zgfoffce.org