Import and Export Control

The TFDA control import and export of food, drugs, herbal drugs, cosmetics and medical devices in order ensure to ensure their safety, quality and effectiveness.

ImportControl of these products aims to achieve the following:-

• To guarantee quality and safety of food, drugs, herbal drugs, cosmetics and medical devices.
• To encourage importers to source products from reputable suppliers.
• To meet concern by local manufacturers that substandard products subject them to unfair competition.
• To promote indigenous innovations.
• To prevent spreads of diseases and pests.

Exportation of products regulated by TFDA aims to achieve the following:-

• To meet mandatory requirements of importing countries.
• To compete successfully in international markets.
• To establish national reputation as a reliable supplier of high quality products.
• To minimize rejection of exported products.
• To fulfill International agreements e.g. export of controlled drugs.

What does the law say about importation and exportation?

Section 5(l) of the Tanzania Food, Drugs and Cosmetics Act 2003 provides for requirement for compliance to standard of exported and imported foods, drugs, cosmetics and medical devices.

Sections 36 – 38 restrict persons to carry on business of an importer if they are not registered as an importers and food they intend to import and provide for requirements for importation of foods.

Section 73 regulates import and export of drugs, cosmetics and medical devices. It also gives powers to the TFDA to allow parallel importation of drugs (importing a drug into a country without authorization of drug registration holder from another country where it is legitimately placed). According to this section visitors from abroad are allowed to come with small quantities of drugs required during the period of 21 days for medical treatment. It restricts persons to import drugs with shelf life more than 24 months whose remaining shelf life is less than 60% and a drug whose shelf life is equal or less than 24 months whose remaining shelf life is less than 80%.

Requirements for importation of food
Applicants are granted import permits after complying with the following requirements:-

• Registration of an importer and food products to be imported.
• Application for importation by filling the relevant forms with some information required:-
  • Particulars of importers.
  • Particulars of the exporter.
  • Registered food products to be imported.
  • Quantities (in kgs, MT, Litres).
  • Port of entry.
  • Expected time of arrival.
• Expected time of arrival.
• Foods must be inspected and approved by the inspector at the port of entry before being released for distribution in the market.
• Regular laboratory analysis of foods to check for compliance.
• Samples from suspect foods can be taken for laboratory analysis.
• Shelf life of non perishable foods should be more than six months by the time it arrives at the official port of entry.
• Foods found non-complying at the port of entry shall be returned to the country of origin at the expense of the importer or can be destroyed at the expense of the importer.

Requirement for importation of drugs, herbal drugs, cosmetics and medical devices

Importers of drugs fall under the following categories; Governmental departments such as MSD, Non Governmental organizations, whole sellers, Pharmaceutical manufacturers importing raw materials for manufacture of pharmaceutical products, holders of ethical clearance certificate to conduct clinical trials in the country and donations by individuals or organizations to meet specific needs of the country.

Import permits are issued after complying with the following requirements:-

• Registration of pharmaceutical products and importer.
• Application for importation of pharmaceutical products. Information required to be submitted include the following:-
  • The International Non Proprietary name (INN) or the generic name of the drug and its strength.
  • In case of a product containing more than one active ingredient, the name and strength of each ingredient.
  • The Pharmacopoeia specification of the ingredient such as BP, USP.
  • The quantity to be imported for each drug.
  • Name of the supplier.
  • Name of manufacturer.
  • Country of origin.
  • Trade or proprietary name as appropriate.
  • The product registration number as approved by TFDA.
• The application for importation should be accompanied by original Proforma Invoice from the supplier indicating besides the aforementioned information, terms of payment, currency of payment, validity of the proforma, mode of shipment.
• The importer must have a valid permit to deal with importation of pharmaceuticals into the country.
• Payment of the prescribed fees should be made (currently 2% FoB).
• Consignments shall be accompanied with a certificate of analysis relating to the specific batch.
• Products should pass through the port of entry indicated in the proforma.