PXL/HO/Cir-038/2020-21 Date: 23.06.2020
Subject: Tanzania Regulatory Agency (Tmda) Notice On Submission Of Applications For Variation To Registered Medicinal Products Which Require Issuance Of New Medicine Registration Certificates
We would like to inform you that Tanzania Regulatory Agency- Tanzania Medicines and Medical Devices Authority (TMDA) has issued a Public Notice for "Submission of Applications for Variation to registered Medicinal Products which require Issuance of New Medicine Registration Certificates". As per TMDA, the following Variation applications require issuance of a new certificate:
Change in trade name of the medicinal product;
Change in description of the medicinal product;
Change in shelf life of the medicinal product;
Change in container closure pack size for non-parenteral medicinal products;
Change in storage instructions;
Change in marketing authorization holder;
Change in name of the finished product manufacturer; and
Changes to the Local Technical Representative (LTR).
Please refer to the TMDA Public Notice for complete details of procedural formalities for filing variation applications requiring issuance of New Medicine Registration Certificate.
Further, members may kindly be aware, TMDA has been actively participating in the Southern African Development Community Medicines Regulatory Harmonization (SADC-MRH) initiatives through the ZAZIBONA Collaborative Medicines Registration Procedure since March 2019. The ZAZIBONA process is a collaborative procedure for 14 Southern African Development Community (SADC) countries in which national regulatory authorities jointly assess medicines for registration purposes. Currently there are 9 of the 14 member states including Tanzania actively participating in collaborative procedure and in the long term all SADC countries are expected to actively participate depending on their capacity.
Members may please find the ZAZIBONA Collaborative Medicines Registration Procedure for ready reference and understanding.