Frequent Asked Questions (FAQ)

 What is TFDA?

Tanzania Food and Drugs Authority (TFDA), is a regulatory body, established under the Food, Drugs and Cosmetics Act 2003 and is  responsible for controlling the quality, safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices.

It regulates importation, manufacturing, labelling, distribution, storage, promotion and sale and of food, drugs, herbal drugs, cosmetics and medical devices. 

What products are regulated by TFDA?

Food, drugs, herbal drugs, cosmetics and medical devices 

Does the TFDA regulate veterinary drugs?

Yes, TFDA regulates all veterinary drugs manufactured or imported into the country. 

Does TFDA also regulate Pesticides and consumable chemicals?

No, TFDA does not regulate pesticides nor consumable and industrial chemicals.these products are regulated by Tanzania Pesticide Research Institute (TPRI) and Government Chemistry Laboratory Agency (GCLA) respectively.

Does the TFDA regulate illicit drugs?

TFDA regulates only licit drugs which are approved for medical use e.g. methadone, pethidine and morphine. Illicit/Illegal drugs with no approved medical use in Tanzania such as heroin, cocaine and cannabis sativa (bhang) are under the jurisdiction of the Inter-Ministerial Anti-Drug Commission. 

What is the difference between TFDA and TBS?

Tanzania Bureau of Standards (TBS) is a Government institution under the Ministry of Industries and Trade,responsible with setting national standards of quality of all products.

TBS was established under the standards Act No. 3 of 1975.

on the other hand, TFDA is a regulatory body under the ministry of health and social welfare responsible with protecting the public healthy by insuring various National Standards of Food, Drugs,Cosmetics and medical devices are met and adhered to.

TFDA was formed under Tanzania Food,Drugs and Cosmetics Act No 1 of 2003.

What types of permits/licenses are issued by TFDA?

TFDA issues the following licenses or permit according to section 21(2) of the Tanzania Food, Drugs and Cosmetics Act of 2003:-

v     Manufacturing license

v     Whole sale license

v     Retail license/permit

v     Import permit

v     Any other license or permit as the Authority may deem fit

 

What are the procedures for registration on food premises?

(i)                Contact inspector of the area in which the premises you intend to register is located

(ii)             Collect the forms for application for registration of product premises from the inspector

(iii)           Submit to the inspector a duly filled in application form

(iv)           Ensure that your premises is inspected

(v)              Pay relevant fee

(vi)           Following inspection done by the inspector the report shall be submitted to the Tanzania Food and Drugs Authority for approval

(vii)         Obtain your registration certificate from the TFDA/inspector in your area

 

What are the procedures for obtaining a license for selling pharmaceuticals?

(i)                Write a letter of intention of dealing with pharmaceutical to Director General TFDA and a copy to inspector of the area you intend to open the business

(ii)             Make sure your premise is inspected (by an inspector of your area) 

(iii)           The inspection report is then submitted to the TFDA for consideration

(iv)           The Authority has the  final say on location and name of the premise

(v)              If approved, applicant will be informed and required to pay the fee

(vi)           Obtain registration certificate from the TFDA

(vii)         License is renewable every year on 1^st July

How TFDA regulates importation of drugs?

Prior importation of pharmaceutical product, importers must obtain approval from the TFDA. A proforma invoice from the manufacturer indicating the name, amount and price of each product is submitted to TFDA. The particulars of this invoice are checked for accuracy before approval.

At the port of entry, the consignment is inspected to make sure the importer has abided to the law. Samples are taken for laboratory analysis. This ensures products entering into the market are safe, effective and of good quality.

Does TFDA register pharmacists?

TFDA is not registering pharmacists. They are registered by the Pharmacy Council which was established by the Pharmacy Act of 2002. 

Does TFDA monitor Product Complaints?

The objective of product complaint activity is to monitor the quality and safety of food, drugs, herbal drugs, cosmetics and medical devices circulating on the Tanzania market. The following cases should be reported:

 

1. Lack of efficacy of drugs, herbal drugs and medical devices
2. Poor packing
3. Improper storage conditions during transportation
4. Poor or improper labeling
5. Change in colour of the product
6. unusual smell
7. Turbidity in injections

When to report product complaint?

Complaints should be reported as soon as it is encountered.

Who should report a product complaint?

It is the responsibility of all healthcare professionals and consumers

 

What is pharmacy Council ?.

Pharmacy Council....

 

Where to report:

Complaints should be reported to:

Director General, Tanzania Food and Drugs Authority

Box 77150Dar Es salaam, Tanzania

Telephone: 255 22 2450512 or 2450751 or 2450108

Fax: 255 22 2450793

It is also in the best interest of patients themselves to report any problem or complaint faced. The reporter should retain the manufacturer’s original pack of the product for cross-checking.

The Information submitted will be treated confidentially.

 

For more information contact TFDA