The Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2021

7. Training on Good Regulatory Practices Training on compilation and assessment of quality of Active Pharmaceutical Ingredients Training on compilation and assessment of quality of Finished Pharmaceutical Products Training on compilation and assessment of bioequivalence studies data Training on compilation and assessment of quality of biological and biosimilar products Training on compilation and assessment of non – clinical and clinical studies data Training on compilation and assessment of herbal medicines

8. Training on Good Manufacturing Practices

9. Training on Good Storage and Distribution Practices

10. Training on Good Clinical and Laboratory Practices

11. Training on Pharmacovigilance and Risk Management 25 FEES IN USD (per person) 500 500 500 500 1,000 800 500 1,000 100 1,000 500 Tanzania Medicines and Medical Devices (Fees and Charges) GN. NO. 686 (Contd.)

13. Training on Quality Management System - ISO 9001

14. Training on Quality Management System - ISO17025

15. Training on Quality Management System - ISO13485

16. Training on Quality Management System - ISO15189

17. Training on laboratory analytical techniques

18. Training on analytical method development and validation

19. Training on microbiological testing ACCREDITATION SERVICES

21. Resubmission of documentation for accreditation

22. Extension of non-critical scope (desk review)

25. Scope extension (if it involves site visit) 100 400 400 400 400 800 1,000 500 200 300 200 500 100 500 26 Tanzania Medicines and Medical Devices (Fees and Charges) GN. NO. 686 (Contd.) __________ FIFTH SCHEDULE __________ (Made under regulation 12(3)) COMPOUNDING FORM TMDA No.................. Station .................... Date ....................... I, ....................................................................................................................... (name) of ......................................................................................................................... (address) do hereby admit that I have contravened section/regulation .............................. by ..................................................................................................................... (state the provision of law contravened) (state particulars of offence) ............................................................................................... and hereby declare that rather than being prosecuted for the commission of the aforementioned offence, on my own free will, I admit that the said offence be compounded under regulation 11 of the Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2021 by ........................................................................................................................... (name of officer compounding the offence) AND I,...................................................................................... (the name and designation of officer compounding the offence .............................................., in exercise of the power conferred upon me by regulation 11 of the Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2021, hereby order that................................................................................................................... (name of the offender) to pay the sum of ....................... Tanzania shillings (TZS. ..............) by way of compounding and that the following exhibit(s) are hereby forfeited to the Government. (List products forfeited) ............................................................................................................................. ............................................................................................................................. Dated this ........................................ day of ..........................................., 20........ ..................................................... (Signature of offender) ................................................................. (Signature of officer compounding offence) ................................................................. .................................................... (witness) (witness) 27 Tanzania Medicines and Medical Devices (Fees and Charges) GN. NO. 686 (Contd.) The payment of the said sum of ..................................Tanzania shillings has been made vide control No. ........................ Dated........................which has been issued to the offender. .............................................................. (Signature of Officer compounding offence) This form shall be issued in triplicate and the original copy shall be served to the offender. A duplicate copy shall be forwarded to the accountant, and the triplicate copy to the Director General. Dodoma 6th September, 2021 DOROTHY O. GWAJIMA Minister for Health, Community Development, Gender, Elderly and Children 28