Procedures for Marketing Authorization
A medicine may be granted marketing authorization in Tanzania provided it meets the following conditions in tandem with Regulation 5 of the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015:
- The availability of the medicine is in the public interest;
- The medicine is safe, efficacious and of acceptable quality;
- The premises and manufacturing operations comply with the current Good Manufacturing Practices requirements as provided in the regulations; and
- The medicine complies with any other requirements as may be prescribed by the Authority.
All pre-requisites for registration are prescribed in the Regulations and various guidelines for registration of Human Medicines, Veterinary Medicines, Herbal Medicines and Biocidals. When preparing a dossier for submission relevant guidelines should be used.
Applications for marketing authorization of medicinal products should be lodged through the Online Trader Portal and once payment has been received, the Applicant should submit the physical samples to TMDA offices.
- Registration is valid for 5 years after which renewal is required. Information required during renewal applications can be found in the Guidelines on Submission of Documentation for Renewal of Registration of Medicinal Products, January 2021
- It is the responsibility of the applicant to inform the Authority of any changes made to their medicine by applying for a variation of the registered product. Variation guidelines should be consulted when compiling these applications