TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

REVISED GUIDELINES FOR MARKETING AUTHORIZATION OF HUMAN MEDICINAL PRODUCTS

1. Tanzania Medicines and Medical Devices Authority (TMDA) would like to inform its esteemed stakeholders that the Guidelines for Marketing Authorization of Human Medicinal Products have been reviewed to align with the requirements of international best regulatory practices. The review included consolidation of the individual guidelines for registration of new pharmaceuticals into a single document titled the Compendium of Guidelines for Marketing Authorization of Medicinal Products which has been in effect since 1^st July 2020.
2. The compendium incorporates updates to the existing guidelines and introduces two new documents, the Quality Information Summary and Guidelines on Naming of Medicinal Products.
3. This Compendium supersedes the Guidelines on Submission of Documentation for Registration of Human Pharmaceutical Products, 1^st Edition, January 2015 and all its annexed guidelines. The guidelines for registration of veterinary medicines, herbal medicines, vaccines and biotherapeutics remain as separate documents, however where relevant, the compendium requirements may be applied.
4. This notice aims to remind applicants to adhere to all the requirements of the compendium when submitting new applications. For more detailed information about the changes made to the guidelines, please Click here.
5. In view of the changes made to the guidelines, a grace period of up to 31^st December 2020 is given for submission of applications without incorporating QIS. Thereafter, from 1^st January 2021, all applications must include QIS document.
6. For any enquiries or clarifications, please contact the Authority through the address indicated below.
7. We thank you for your continued cooperation.