ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

02^nd August, 2022

REQUEST FOR EXPRESSION OF INTEREST FOR SHORTLISTING EVALUATORS OF MEDICINES

1. Tanzania Medicines and Medical Devices Authority (TMDA) is an Executive Agency under the Ministry of Health established under the Tanzania Medicines and Medical Devices Act, Cap. 219. TMDA is responsible for controlling the quality, safety and effectiveness of medicines, medical devices and diagnostics as well as regulation of tobacco products.
2. The Authority invites Expression of Interests (EOIs) from qualified Tanzanians to be engaged in evaluation of medicine applications and applications to conduct clinical trials within the Directorate of Human and Veterinary Medicines for the financial year (2022 – 2023).
3. The scope of assignment shall be but not limited to the following:
   1. Evaluation of drug registration dossiers, focusing on the following technical areas: -
      1. Administrative and Product Information Including Product Labelling;
      2. Active Pharmaceutical Ingredients (API);
      3. Finished Pharmaceutical Products (FPP);
      4. Non-clinical Study Reports; and
      5. Clinical Study Reports (Safety and Efficacy Data and Bioequivalence Studies Data).
   2. Evaluation of clinical study protocols submitted for application to conduct clinical trials in Tanzania Mainland.
   3. Review of safety, efficacy and quality data of registered products.
4. The desired qualification and experience to offer the required services are as follows: -
   1. Qualification requirements preferably in pharmacy; human or veterinary medicine; herbal medicines; medical engineering; microbiology; biochemistry; pharmacology and toxicology; molecular biology and biotechnology; chemistry or any other related qualification;
   2. Possession of registration to practice issued by the relevant Professional Body; and
   3. The description and experience of undertaking similar assignment in at least in the last one year.
5. Interested experts with the requisite competencies should submit the following:
   1. A cover letter expressing interest addressed to the Director General, Tanzania Medicines and Medical Devices Authority, Off Nelson Mandela Road, Mabibo External, P.O. Box 77150, Dar es Salaam, Tanzania.
   2. A detailed CV indicating relevant experience;
   3. Certified copies of a degree certificate and registration with relevant professional body.
6. Interested experts who wish to be provided with clarifications on this matter may visit TMDA Sub Office which is located Off Nelson Mandela Road, Mabibo External, Dar es Salaam from 8.00 a.m. to 3.00 p.m. on Mondays to Fridays inclusive, except on public holidays.
7. Expression of interest documents should be submitted electronically through email address: medicines@tmda.go.tz copied to felchism.apolinary@tmda.go.tz and mtani.magesa@tmda.go.tz with the subject titled “EXPRESSION OF INTEREST (EOI) FOR EVALUATION OF MEDICINES”.
8. The deadline for submission is 14.00 hours local time on Monday 8th August, 2022. Late submission of Expression of Interest shall not be accepted for evaluation irrespective of circumstances.