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.

Import Control 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

• Food to pass through a port of entry indicated in the application form.

• 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
• Drug inspector at the port of entry inspect products before being released for use in the country

• The drug inspector takes samples for analysis as routine where consignments are released to the importer, mandatory e.g. for anti-malaria drugs such as SPs, quinine, artesunate and some antibiotics such as ampicillin, ciproflaxin, metronidazole, cotrimoxazole amoxyllin, etc. These are subjected to laboratory analysis before the inspector at the port of entry releases the consignment.

• Substandard or non-registered products are condemned or re-exported. This is preceded by re-inspection to confirm that the consignment is intact. Generally Drug inspector and Custom officials supervise re-exportation exercise.

Export Control of foods, drugs, cosmetics and medical devices

Despite the fact that, it is the responsibility of importing country to safeguard the health of its people, exporting countries have a role to play as per International agreements, such as those stipulated under World Trade Organizations (WTO) and other conventions. The need to have export control of products is to maintain or increase the confidence of the purchaser in the quality, safety and effectiveness of the products exported. Assurance is not only limited to end products quality, safety and effectiveness, but on the status of the control infrastructure. These include assurance on adequacy of legislation, effectiveness of inspection and laboratory services and the administration of the product control activities. Also importing countries demand WHO type GMP certification of manufacturing. 

Control of food exports

Many importing countries demand assurance from a food regulatory agency that the food complies with the relevant standards. CODEX ALIMENTARIUS COMMISSION STANDARDS are used as reference standards. Practices in relation to International trade in food recognise WTO agreements and Sanitary and Phytosanitary measures (SPS). These must be science based and must not apply stringent measures that cannot be justified scientifically. Importing countries demand Sanitary certificates (Health certificates) from recognized government regulatory agency. The certificate contains among other particulars; type and quantities of food, quality status of the food, whether processed in registered and licensed premises and any specific requirement prescribed by the importing country.

In Tanzania, health certificates are issued to exporters whose trade partners demand such certificates. Before they are issued, consignments are inspected and samples from such consignments are subjected to laboratory analysis to ascertain its quality and safety

Control of drugs, cosmetics and medical devices export

Drugs for export may require GMP certification by TFDA   if the importer requires. Drugs may be required to be subjected to laboratory analysis to check compliance with specifications. An export certification is issued upon being satisfied of the product quality, safety, effectiveness and that the product is allowed to circulate in the local market.

Problems associated with control of import of food, drugs, cosmetics and medical devices

• Importation through unofficial ports of entry.
• Lack of awareness among importers of the products on the  requirements for importation therefore results in late processing of importation, which causes unnecessary delays.
• False declaration of type or and quantities of products imported. This means that some products can pass through port of entry without being inspected.
• Evolving new health risks associated with the products such as BSE.
• Fake proforma invoice
• A significant quantity of the consignment being declared as free sample

TFDA recognizes the existence of the aforementioned problems and currently inspection in general is being evaluated in order to come up with a new approach, which shall take into consideration the existing limitations.