General Guidelines for Submitting Applications for Registration of a Medicine. First Edition, 2008 - Zambia
(2008; 78 pages)


These guidelines are to assist applicants in completing application forms and preparing dossiers for submission to the Zambia they prescribe the format and content of registration dossier, number of samples, fees payable and labelling and package insert information requirements. 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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