TMDA Registration
Requirements For Registration
- Cover letter
- Application form (MP A)
- A table of contents listing all sections of the product’s dossier and documents and there corresponding page number
- Medical product dossier as per requirements and formats prescribed in guidelines for registration of human, veterinary, herbal, human biological, veterinary biological, and any other relevant guidelines in force at the time of submission
- An original certificate of pharmaceutical Product (WHO format) on official papers of the issuing competent authority
- Adequate quantity of samples to allow full analysisof the product as per product specification plus one repeat analysis
- A site master file as stipulated by the GMP regulations in force at the time of application
- No refundable application fees for registration of medical products in Tanzania and GMP inspection fee for manufacturing facilities as described in fees and charges Regulation in force
- Particulars of a person with appropriate knowledge of all aspects of medicine who shall be responsible for communication with TMDA
