MEDICINES AND DEVICES LICENCES FROM TMDA

The Tanzania Medicines and Medical Devices Authority (TMDA) is the primary organization for registration of premises, products and issuance of licenses to businesses trading products related to drugs and medical services.

The objective of TMDA is to protect the health of consumers against hazards associated with medicines, herbal drugs and medical devices.

Any person interested in selling, storing or manufacturing of drugs and medical devices must register the business premise with TMDA before commencing the business operation. In addition, he/she should obtain business license for trading specific product.

Licenses are usually renewed at intervals of one year (usually on 1st July each year). These licenses include those for manufacturing, wholesale, retail and those for import and export businesses.

After registering the premise (factory, warehouse or shop) and obtaining business license, a trader must register a product he/she is intending to sell or produce.

Application for premise registration and business license are usually done simultaneously.

TMDA activities are governed by the Tanzania Medicines and Medical Devices Act, Cap 219 of 2019

Business permit for Drugs and medical devices

Business permits are issued to all traders willing to manufacture, sell, import or export products related to drugs, and medical devices. Those traders include: Manufacturers, wholesalers, retailers, importers and exporters. It is illegal as per TMDA Act 2019 section 20 to trade without license.

Business permit for manufacturing

Traders who wish to manufacture drugs and medical devices must register their factory/premise with TMDA and subsequently obtain business license. Before business license and certificates of registration of premises are issued, TMDA conducts Good Manufacturing Practice (GMP) inspections to make sure that the premises environment and processes guarantees safety to consumers. GMP is conducted for both local and foreign factories. For more information on steps for applying these permits please click the blue links below.

Obtain pharmaceutical manufacturing business permit

Obtain medical device manufacturing permit

Obtain business permit for wholesalers

These are distributors who imports medical goods and supply to retailers and government buyers. These are traders who import their products and sell to retailers or those who buys locally from importers and sells to retailers.

Obtain business permit for retailers

These are traders providing services to final consumers. They include dispensaries, normal medical devises shops and pharmacies.

Registration of drugs and medical devices

All products in form of drugs and medical devices are require to be registered with TMDA. It is mandatory to register all products, both locally manufactured and imported, for the purpose of quality control. TMDA conducts laboratory test to all products to ascertain whether they meet prescribed standards. No one is allowed to sell, distribute or import an unregistered product in Tanzanian market. Click on the links below to see steps

Obtain drugs/medicine registration certificate

Obtain medical device registration certificate

Obtain import permit online

Importers can apply for import permits through an online system available on its website. Click above headline to access steps

Registration of promotional materials

Premise registration

Premise registration allows TMDA to assess whether the medicine and medical devices storage facility is in hygiene and conforms to storage standards.