FOOD AND DRUGS LICENCES FROM TFDA

The Tanzania Food and Drugs Authority (TFDA) is the primary organization for registration of premises, products and issuance of licenses to businesses trading products related to food, drugs, cosmetics and medical services.

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

Any person interested in selling, storing or manufacturing of food, drugs and medical devices must register the business premise with TFDA 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.

TFDA activities are governed by the Tanzania Food, Drugs and Cosmetics Act of 2003.

Obtain business permit

Business permits are issued to all traders willing to manufacture, sell, import or export products related to food, drugs, cosmetics and medical devices. Those traders include: Manufacturers, wholesalers, retailers, importers and exporters. It is illegal as per TFDA Act 2003 section 20 to trade without license.

Business permit for manufacturing

Traders who wish to manufacture drugs, food, cosmetics and medical devices must register their factory/premise with TFDA and subsequently obtain business license. Before business license and certificates of registration of premises are issued, TFDA 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 food manufacturing permit

Obtain pharmaceutical manufacturing business permit

Obtain cosmetics manufacturing business license

Obtain medical device manufacturing permit

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.

Business permit for retailers

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

Registration of food, drugs, cosmetics and devices

All products in form of food, drugs, cosmetics and medical devices are require to be registered with TFDA. It is mandatory to register all products, both locally manufactured and imported, for the purpose of quality control. TFDA 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.

Obtain import permit

Any trader willing to import food, drugs, cosmetics or medical devices must obtain import permit and a certificate of premise registration. Import permit allows the trader to conduct the business operations. Premise registration allows TFDA to assess whether the medicine/food/cosmetics/medical devices storage facility conforms to standards. The trader must make sure the product he/she is intending to import have been registered with TFDA. If it has not been registered it is the duty of the trader to register the product with TFDA.

Obtain import permit online

TFDA encourages importers to apply import permits through an online system available on its website. The service started 2015.

Obtain clinical trial certificate

Registration of promotional materials

Premise registration

Premise registration allows TFDA to assess whether the medicine/food/cosmetics/medical devices storage facility is in hygiene and conforms to storage standards.