TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

PUBLIC NOTICE

21^st August, 2019

IMPLEMENTATION OF THE GUIDELINES ON VARIATIONS OF REGISTERED MEDICINAL PRODUCTS, SECOND EDITION JULY 2019

1. Tanzania Medicines and Medical Devices Authority (TMDA) formerly Tanzania Food and Drugs Authority (TFDA) would like to notify its esteemed stakeholders that the current Guidelines on Variations of Registered Medicinal Products, 2^nd Edition July, 2019 became effective on 1^st of July, 2019.
2. Section 2.3. P.3 (manufacture) and sub section 31a-31c of the current guidelines states that addition or replacement of a manufacturing site for part or all of the manufacturing process for a finished product is a minor variation which is contrary to regulation 5 (5) of the Tanzania, Food, Drugs and Cosmetics (Registration of Medicinal Products) Regulations, 2015 which states that medicinal products with different manufacturing sites are considered to be different products and thus require separate applications.
3. This is to inform you that implementation of section 2.3. P.3 (manufacture) and sub section 31a-31c will take effect after amendment of the Tanzania, Food, Drugs and Cosmetics (Registration of Medicinal Products) Regulations, 2015.
4. In the meantime variation applications which involve addition or replacement of a manufacturing site for part or all of the manufacturing process for a finished product shall require submission of a new application accompanied by payment of relevant fees as outlined in the Fees and Charges Regulations in force. Nevertheless, such applications shall be compiled as per the requirement set out in the Guidelines on Variations of Registered Medicinal Products, 2^nd Edition, of July 2019.