Registration and Licensing of Premises
Registration and Licensing of Premises
Registration of wholesale pharmacies that import medicines and pharmaceutical manufacturing facilities is mandated under Section 21 of the Tanzania Medicines and Devices Act. Cap 219.
Retail pharmacies, wholesale pharmacies that do not import pharmaceuticals but distribute pharmaceuticals within the country and Accredited Dispensing Outlets (ADDOs) are registered by the Pharmacy Council as dictated under Section 37 of the Pharmacy Act, 2011.
Wholesale pharmacies for veterinary medicines are also registered by TMDA while retail outlets and clinics for veterinary services are registered by the Veterinary Council of Tanzania (VCT) based on the Memorandum of Understanding (MoU) signed by TMDA and VCT.
- 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.
For detailed requirements, please refer to Regulation 5 (2) and 6 (1) of the Tanzania Medicines and Medical Devices (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015
Applications are processed at TMDA Zone offices.
- Lodge and application online through the Trader Portal;
- Make necessary payment as per Fees & Charges Regulation;
- TMDA inspection of the premise as per Inspection Checklist; then
- Premise registration & issuance of business permits for compliant premise.
Business permits expire on 30th June of each year, after which renewal of business permit is required.
For detailed requirements, please refer to Tanzania Medicines and Medical Devices (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015
