Procedures for Marketing Authorization
The sale, supply or importation of any medicine in Tanzania is prohibited unless the medicine is registered. Regulation 5 of the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015 provides conditions for marketing authorization of medicines in Tanzania and requirements for submission of applications for registration of medicinal products.
The conditions for marketing authorization include:
- 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;
- The medicine complies with any other requirements as may be prescribed by the Authority.
The requirements for registration of medicines in Tanzania are prescribed in the regulations and various guidelines. When preparing a dossier for submission relevant guidelines should be used. To view the regulations, Click here and to view the guidelines, Click here.
Applications for marketing authorization of medicinal products can be submitted in hard and soft copies or electronically through on-line platform. Applicants are encouraged to use on-line platform for submission of applications for marketing authorization. Application form together with dossier in appropriate technical format in hard and soft copies and specified number of samples according to respective guidelines should be submitted to TMDA. To fill in an application form, Click here (Application form of Marketing authorization on New And Generic Human Medicinal Product).
For online submission of new application for marketing authorization, Click here.
The market authorization (registration) of the medicinal product is valid for five (5) years, after which the registration is subject for renewal. When a change is introduced to a registered medicinal product, such change needs to be approved by TMDA.
- To apply for renewal of registration of medicinal product, refer to the Guidelines on Submission of Documentation for Renewal of Registration of Human and Veterinary Pharmaceutical Products, March 2020.
- To apply for approval of alterations, refer to the Guidelines on Variations on Registered Medicinal Products, March 2020.
For other related guidelines for marketing authorization of medicinal products, click here.
For fees and charges, click here.