Premise Registration and Licensing

The Directorate of Inspection and Surveillance is responsible with ensuring that all dealings is food, drugs, herbal drugs, cosmetics and medical devices is done after obtaining relevant licenses and permits.

The Tanzania Food, Drugs and Cosmetics Act of 2003 restricts sale, storage or manufacture of food, drugs, and medical devices unless in premises registered by the Tanzania Food and Drugs Authority (TFDA) and the manufacturer holds product license issued by the Authority.  Registration Certificate and product license is both granted to an applicant after fulfilling the necessary requirements as provided by the Law. 

Conditions for registration and licensing of premises vary from one product to another. For example manufacturing of pharmaceuticals requires compliance to GMP (Good Manufacturing Practice) and food manufacturing to HACCP (Hazard Analysis Critical Control Point).    

Licenses are usually renewed at intervals of one year (usually on 1^st July each year)

 

Types of permits/permits  

•  Manufacturing license

•  Wholesale license

• Retail license

• Import permit

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

 Legal Requirements for registration of premises

No person shall manufacture for sale, sell, supply or store products regulated under section 18 of the Tanzania Food, Drugs and Cosmetics Act, 2003 except in premises registered by TFDA. Every application for registration or renewal of registration of premises should be made to the Authority in the prescribed form, accompanied by prescribed fee. The Director General or any person on his behalf: - 

(a)         Registers the premises if he is satisfied that the prescribed requirements for which the premises is intended have been complied with

(b)        Keeps registers of all registered premises

(c)         may, for good and sufficient reasons refuse to register, or may cause to be deleted from the register, any premises which are or have become unsuitable for the purposes for which they were registered;

Any person who contravenes or fails to comply with this section, commits an offence and upon conviction is liable to a fine of not exceeding five million shillings or to imprisonment for a term of not exceeding two years or to both such fine and imprisonment.

Procedures for registration of manufacturing sites/premises

(i)              Read the Tanzania Food, Drugs and Cosmetics Act 2003 and its related regulations

(ii)           Contact the TFDA inspector of the area  (District Pharmacist/Health Officer/Veterinary Officer/any other appointed person) in which the premises you intend to register is located

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

(iv)          Submit to the TFDA inspector duly filled application form for registration of premises

(v)             Ensure that your premises is inspected by  inspector of your area

(vi)          Pay the fees prescribed by the TFDA

(vii)        An inspection report is  submitted to the Tanzania Food and Drugs authority, by the inspector, for consideration

(viii)     Upon approval, obtain your registration certificate from TFDA headquarters or inspector in your area

 Procedure for obtaining a License for selling pharmaceuticals

(i)             Purchase the Guidelines for dealing in part II poisons from the Tanzania Food and Drugs Authority (TFDA) or Regional Pharmacists and read it to understand the needed requirements.

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

(iii)         Contact the inspector of the area in which you intend to open the business for inspection of the premises. (in case of a pharmacy, you should acquire a Pharmacist registered with the Pharmacy Council who will supervise the pharmacy)

(iv)          Following inspection done by the inspector the report shall be submitted to TFDA Authority for approval.

(v)             The Authority have final say on location and name of the premises

(vi)          If approved, applicant will be informed and pay the fees as the Authority may prescribe.

(vii)        Obtain registration certificate from the TFDA

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

Change of business ownership or any other change

According to section 19 of the Tanzania Food, Drugs and Cosmetics Act 2003, any change of ownership of the business or any other change of a registered premise shall be notified to the Authority immediately.

For more information contact TFDA