ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

22^nd August, 2022

UPLOADING PICTURES AND/OR IMAGES OF COMMERCIAL SAMPLES SUBMITTED IN SUPPORT OF APPLICATIONS FOR REGISTRATION AND RE-REGISTRATION OF MEDICINAL PRODUCTS

1. The Authority would like to inform its esteemed stakeholders who are intending to submit applications for marketing authorization of medicinal products that, all new applications and renewal of registration applications submitted for marketing authorization will be required to include a picture and/or image showing visual or physical appearance of the applied medicinal product. This requirement will be effective from 1st October, 2022.
2. A medicinal product’s picture and/or image should show how the product looks like when visualized by naked eye when its primary container is opened. The image or picture should be in either png, jpeg or jpg format and should be taken from all possible angles (3 dimension if applicable) and coloured showing shape and markings (where applicable), actual colour, etc. It should also be noted that, appearance of a picture/image should be in line with the description of a medicinal product provided in the finished product specifications and in the Summary of Product Characteristics/Package Insert.
3. In case of challenges in uploading a medicine’s picture and/or image, the following TMDA staffs are available for support: -
   1. Fabian Lwanole [Phone: +255 762 533 530, Email: fabian.lwanole@tmda.go.tz]
   2. Salehe Mwenyevyale [Phone: +255 753 747 474, Email: salehe.mwenyevyale@tmda.go.tz]
   3. Sadam Kyamani [Phone: +255 783 992 449 , Email: sadam.kyamani@tmda.go.tz]
   4. Masuke Ng’habi [Phone: +255 738 777 870, Email: masuke.nghabi@tmda.go.tz]
4. We thank you for your continued cooperation.