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(2008; 47 pages)
The Pharmaceutical Act (No. 14) of 2004 requires that pharmaceutical products including vaccines and other biological medicinal products intended to be marketed in Zambia meet acceptable standards of quality, safety and efficacy and at the same time be assessed to have been manufactured in facilities which comply with current Good Manufacturing Practices (cGMP).
These guidelines have been developed to provide requirements in support of quality, safety and efficacy in respect of vaccines and other biological medicinal products 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...