Frequently Asked Questions
No, TMDA does not register pharmacists. They are registered by the Pharmacy Council established under the Pharmacy Act of 2011.
Complaints should be reported to:
Tanzania Medicines and Medical Devices Authority (TMDA),
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 TMDA.
Yes. TMDA 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.
Prior importation of regulated products, importers must obtain approval from TMDA. A proforma invoice from the applicant indicating the name, amount and value of each product is submitted to TMDA. 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.
- Write a letter of intention of dealing with pharmaceutical to Director General TMDA and a copy to the office of District Medical Officer in the area you intend to open the business.
- Collect application forms from TMDA 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 TMDA.
- 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.
TMDA 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
No, TMDA regulate pesticides nor consumable chemicals. These products are regulated by Tanzania Pesticide Research Institute (TPRI) and Government Chemistry Laboratory Agency (GCLA) respectively.
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.
Human and Veterinary Medicines, Medical devices and Diagnostics.