Registration and Licensing of Premises
Section 21 of the Tanzania Medicines and Devices Act, Cap 219 mandates TMDA to register wholesale pharmacies that import medicines and pharmaceutical manufacturing facilities. Section 37 of the Pharmacy Act, 2011, mandates the Pharmacy Council to register Accredited Dispensing Outlets (ADDOs), retail pharmacies and wholesale pharmacies that do not import pharmaceuticals but distribute pharmaceuticals within the country.
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. Click here to access the MoU.
The applications for premises registration and business permits shall be submitted to TMDA through a dully filled in application form. Click here to access the application form. For online application, Click here. Applications for registration of all type of premises under the mandate of TMDA and business permits are processed by TMDA zones offices except for licensing of new manufacturing facilities. Click here to link with zone offices.
The necessary attachments to be accompanied with the applications are as follows;
- 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.
Upon receipt of application for premises registration accompanied with proof of payment of fees in accordance with the fees and charges regulations Click here to access the regulations, the Authority shall inspect the premises using a checklist Click here to view the inspection checklist to verify if all conditions have been met, and if satisfied register the premises and issue premises registration certificate and business permit.
Based on the regulation 8(3) of the Tanzania Medicines and Medical Devices (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015, Click here to access the regulations, a business permit issued shall expire on 30th June every year, therefore, applications submitted one month before this date shall be issued with a permit for the next financial year. The certificate or business permit issued for a given premises shall not be transferred to another premises until approval from the Authority.
Applications for renewal of business permits shall be submitted to TMDA before 30th June of each year by submitting a duly filled in application form accompanied with proof of payment of fees and commitment from the pharmacist who will supervise the respective premises. To submit online applications for renewal of business permit apply Here.