TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
15th May, 2020
NOTICE ON SUBMISSION OF APPLICATIONS FOR VARIATION TO REGISTERED MEDICINAL PRODUCTS WHICH REQUIRE ISSUANCE OF NEW MEDICINE REGISTRATION CERTIFICATES
- TMDA wishes to inform all marketing authorization holders of registered medicinal products who intend to apply for
variation to the registered medicinal
products on changes that may cause revision of the contents in the original certificates of medicine registration.
- In the event that the requested changes have been granted approval, the original medicines registration certificates should be returned to
TMDA so that new certificates reflecting the accepted changes can be issued.
- It should be noted that, during submission of these types of variation applications, the original certificates of
medicine registration should be attached along with
other supporting documents stipulated in the current variation guidelines for a particular change.
- Variation applications which require issuance of a new certificate includes:-
- 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).
- We thank you for your continued cooperation.
Acting Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
PSSSF Building, 10th Floor,Makole Road
P. O. Box 1253, Dodoma Or
P. O. Box 77150, Dar es Salaam
Phone: +255 22 2452108/2450512/2450751
Toll Free: 0800110084