Posted On: Dec 24, 2022
THE UNITED REPUBLIC OF TANZANIA
MINISTRY OF HEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
ISO 9001: 2015: CERTIFIED
22nd December, 2022
A CHECKLIST FOR SCREENING OF APPLICATIONS FOR REGISTRATION OF HUMAN MEDICINAL PRODUCTS BEFORE THEIR SUBMISSION
- The Authority has encountered several major deficiencies in the submitted applications for marketing authorization of human medicinal products and this results in unnecessary delays in the assessment and approval process.
- To ensure the complete submission of information/data, the Authority has prepared a checklist which can be used by applicants to screen applications before their submission. The checklist provides oversight assurance to the manufacturer and as well as TMDA that the information provided is complete in line with the applicable guidelines and henceforth facilitates an efficient and effective assessment process.
- This checklist has been developed for guidance only to help the applicant to prepare and submit a complete product dossier and therefore should be read in conjunction with all relevant guidelines. Applicants should in all cases comply with requirements governing the registration of medicines in Tanzania. For more detailed requirements, refer to the relevant Medicines Registration Guidelines available at www.tmda.go.tz/publications/42.
- The applicants who are intending to submit applications for marketing authorization of human medicinal products will be required to include a duly filled and signed completed copy of the applicant’s self-screening checklist in Microsoft Word format as part of module 1. This requirement will be effective from 1st January 2023. The recommended self-screening checklist template can be accessed via www.tmda.go.tz/publications/23
- It is anticipated that this checklist will facilitate the compilation of complete applications.
Tanzania Medicines and Medical Devices Authority (TMDA),
P.O. Box 1253, Dodoma.
Tel; +255 222 450512/658 445222/777 700002
Fax; +255 222450793