Guidelines on Application for Registration of Herbal Medicines. First Edition, 2008 - Zambia
(2008; 37 pages)

Abrégé

The Pharmaceutical Act No 14 of 2004 requires that products intended to be marketed in Zambia meet appropriate standards of good quality, safety and efficacy. Also they should be manufactured in facilities, which comply with cGMP requirements. One of the means for ensuring that Herbal Medicinal products meet the required standards of good quality, safety and efficacy is by conducting product specific pre-marketing assessments to determine whether the product should be registered.

These Guidelines have been prepared to provide information to applicants who intend to register Herbal Medicinal products in Zambia.

This document has been developed by the Pharmaceutical Regulatory Authority (PRA) to provide guidance to applicants on the content and format of the Chemistry and pharmaceutical data of such products required for their complete scientific evaluation for quality, safety and efficacy. These guidelines also indicate the order of the material to be submitted and the minimum requirements for product registration. Compliance to these guidelines in the submission of applications will facilitate the speedy processing and evaluation of the application and hence the product licensing. This will enable the prospective licence holders to market their products on time and make them available to the consumers. In view of this, applicants are advised to read these guidelines carefully and adhere in full to the prescribed instructions.

 
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