General Frequently Asked Questions

1. What is TFDA?
Tanzania Food and Drugs Authority (TFDA): is a regulatory body, established under section 4 of Tanzania Food, Drugs and Cosmetics Act, 2003, responsible for controlling the quality, safety and effectiveness of food, drugs,, cosmetics and medical devices.

TFDA controlls importation, manufacturing, labelling, distribution, storage, promotion and sale of regulated products.

2. What products are regulated by TFDA?
Food, drugs, herbal drugs, cosmetics and medical devices.

3. Does the TFDA regulate veterinary drugs?
Yes, TFDA regulates all veterinary drugs manufactured or imported into the country.

4. What is the difference between TFDA and TBS?
TFDA is a regulatory body under the Ministry of eHalth and Social Welfare responsible for protecting and promoting public health by ensuring quality, safety and effectiveness standards of Food, Drugs,Cosmetics and medical devices are met and adhered to.

On the other hand, TBS is a parastatal organization under the Ministry of Industry and Trade and its broad mandate is to promote standardization and quality assurance in industry and commerce sectors.

5. 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:-

  • Manufacturing license
  • Whole sale and retail license/permit
  • Import and export permit

NB: These permits are only issued to registered premises and registered products.

6. Does TFDA regulate pesticides and consumable chemicals?
No, TFDA regulate pesticides nor consumable chemicals. These products are regulated by Tanzania Pesticide Research Institute (TPRI) and Government Chemistry Laboratory Agency (GCLA) respectively.

7. Does TFDA regulate illicit drugs?
TFDA regulates only licit drugs which are approved for medical use e.g. methadone, pethidine and morphine. Illicit 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

8. What are the procedures for registration on food premises?

  • Collect application forms from TFDA hq offices, zone offices or from health offices in respective district/council where the premises you intend to register is located.
  • Submit a dully filled application form and submit it to respective office.
  • Pay relevant fees as stipulated in the fees and charges regulations.
  • Obtain your registration certificate from the TFDA/inspector in your area.

N.B: Registration certificates will only be issued to the premises that are compliant to requirements

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

  • Write a letter of intention of dealing with pharmaceutical to Director General TFDA and a copy to the office of District Medical Officer in the area you intend to open the business.
  • Collect application forms from TFDA hq offices, zone offices or from health offices in respective district/council where the premises you intend to register is located.
  • Submit a dully filled application form and submit it to respective office.
  • Pay relevant fees as stipulated in the fees and charges regulations.
  • Obtain registration certificate from the TFDA.
  • N.B:–
  • The Authority has a final say on location and name of the Authority.
  • License will only be issued to the premises that comply to requirements.
  • Validty of license is 1 year, it expires on 30th June every year , and it is subject to be renewed.

10. How does TFDA regulate importation of products?
Prior importation of regulated products, importers must obtain approval from TFDA. A proforma invoice from the applicant indicating the name, amount and value 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 and samples are taken for preliminary screening before Importation approval is granted. Samples may be taken for central laboratory for further analysis if there are doubts of its quality and safety specifications.

11. Does TFDA receive Customer Complaints?
Yes. TFDA receives and handles customer complaints regarding all matters related to regulated products. The aim is assuring the customers on safety and efficacy of the product they consume. This further facilitates in building customer’s confidence on the services offered by the Authority.

  • The following cases should be reported:
  • Lack of efficacy of drugs, herbal drugs and medical devices.
  • Poor packing
  • Improper storage conditions during transportation and storage.
  • Poor or improper labeling.
  • Change in colour of the product.
  • Unusual smell.
  • Turbidity in injections.
  • And any other matter.

12. When and Who to report product complaint?
Complaints should be reported as soon as it is encountered.

It is the responsibility of all stakeholders including healthcare professionals , consumers and general public to report.

13. Where and how to report complaints?
Complaints should be reported to:
Director General,
Tanzania Food and Drugs Authority,
Box 77150,
Dar Es salaam,
Tanzania.
Telephone: 255 22 2450512 or 2450751 or 2450108.
Fax: 255 22 2450793.
Email: info@tfda.go.tz

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.

14. Does TFDA register pharmacists?
No, TFDA does not register pharmacists. They are registered by the Pharmacy Council established under the Pharmacy Act of 2011.

 
 
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