Registration and Licensing of Premises
According to Section 18 of the Tanzania Medicines and Medical Devices Act, Cap 219. restricts the manufacture for sale, sale, supply or storage of medical products to premises registered by TMDA.
All retail business premises for human and veterinary medicines are registered and licensed by the Pharmacy (www.pc.go.tz) and Veterinary Council (www.tva.or.tz), respectively.
Domestic manufacturing facilities; retail premises for biocidal; and importing wholesale premises for human and veterinary medicines are registered and licensed by TMDA.
The application for premise registration and licensing should be accompanied by the following;
- Copy of Certificate of Registration from Business Registration and Licencing Authority (BRELA).
- Tax Payer Identification Number (TIN).
- A copy of a contract with superintendent/in charge of the business.
- A copy of registration certificate of the superintendent issued by the respective councils or professional boards.
- Premise layout/sketch.
- Copy of Memorandum and articles of Association.
For detailed requirements, please refer to the The Tanzania Medicines and Medical Devices (Good Storage and Distribution Practices) Regulations, 2021
Requirements for registration and licensing of domestic manufacturers;
- A copy of Certificate of Incentives from the Tanzania Investment Centre (TIC)
- An approval from the National Environmental Management Council (NEMC) on suitability of the site/plot for medical devices manufacturing activities
- Facility layout
- Copy of Certificate of Registration from Business Registration and Licensing Authority (BRELA).
- Tax Payer Identification Number (TIN). .
- A copy of a contract with superintendent/in charge of the business.
- A copy of registration certificate of the superintendent issued by the respective councils or professional boards.
- Premise layout/sketch
- Copy of Memorandum and articles of Association
List of Manufacturing facilities
- List of domestic pharmaceutical manufacturing facilities;
- List of domestic pharmaceutical manufacturing facilities that are GMP compliant;
- List of domestic manufacturing facilities that are at different stages of construction;
- List of registered and licensed hospital and pharmacy-based manufacturing facilities;
All applications for the registration and licensing of premises for domestic pharmaceutical manufacturing facilities are processed by all 8 TMDA Zone offices located at the HQ of the respective zone. The zone offices include Arusha (Northern Zone); Mtwara (Southern Zone); Tabora (Western Zone); Dar es Salaam (Eastern Zone); Dodoma (Central Zone); Geita (Lake Zone West); Mwanza (Lake Zone East); and Mbeya (Southern Highland Zone).
All applications for the registration and licensing premises for pharmaceutical manufacturing facilities are made online through the Trader Portal. Make necessary payment as per Fees & Charges Regulation.
Inspection of the premises is conducted as per the TMDA Inspection Checklist. The business permit issued shall expire on 30th June every year, after which renewal of the business permit is required.