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You are here : Country Regulations
PHARMACEUTICAL REGULATIONS IN TANZANIA
Training and consultancy services
Consultancy and Expert Services offered by the Authority shall be charged US$ 250 per Man-day. Reimbursable expenses and traveling & accommodation expenses shall be charged as per the actual expenses incurred.
- Training of any person other than Tanzanian student at TFDA shall be charged a fee as provided under the schedule to these regulations.
Duty to collect fee
- Fees paid under these Regulations shall be collected and appropriated by the Authority;
- Notwithstanding the provision of sub-regulation (1) of this regulation the Authority shall devise a safe and good method of fees collection and may delegate the duty of fees collection to any Local Authority or any agent in whose area the business in respect of which the fees is paid operates.
- Fees paid under these Regulations shall be paid in Tanzania shillings, U$ or its equivalence in convertible currency. Fees and charges not refundable nor transferable
- All fees payable under these regulations are neither refundable nor transferable. Offence
- Any person who contravenes or fails to comply with these regulations or directly or indirectly aid any other person to commit an offence under these regulations shall be guilty of an offence; Penalty
- Any person found guilty of an offence under these regulations shall be liable on conviction to the penalty prescribed by the Act
(1) No person shall carry on any business related to products regulated under the Act unless he has paid the necessary fees prescribed under these Regulations
(2) Any person found operating a business using an expired permit, certificate or license previously issued by the Authority thirty days after its expiry date, shall be required to pay in addition to the due fees or charges a penalty of 25%. Such Penalty also applies to delayed payment of any due fees or charges covered under these regulations. Such person shall be required to meet other requirements prescribed by the Authority for such a business.
Fees Payable by product dealers
-(1) There fees payable to these Regulations by a product dealer in connection with the following matters:-
- Laboratory sample analysis;
- Product evaluation and registration;
- Pre registration GMP inspection;
- Annual medical representative permits;
- Certification of export;
- Annual dealers license/permit;
- Approval of product advertisement;
- Annual retention for registered products;
- Product alteration;
- Duplicate certificate, permit or license;
- Restoration of licenses, certificates or permit;
- Trade fair permit; and
- Laboratory training fees.
– (2) All laboratory tests shall not be charged any overhead expenses in addition to the cost of tests carried on.
Click on this link for more information www.tfda.or.tz
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