ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

PUBLISHING OF TANZANIA PUBLIC ASSESSMENT REPORTS AND SUMMARY OF PRODUCT CHARACTERISTICS FOR REGISTERED PRODUCTS

1. Tanzania Medicines and Medical Devices Authority (TMDA), would like to inform all applicants and our esteemed stakeholders that, in an effort to fulfil its mission of protecting and promoting public health, the Authority has started publishing summaries of product characteristics (SmPCs) and public assessment reports (TPAR) for selected medicines granted marketing authorization in Tanzania Mainland.
2. This initiative intends to promote openness and transparency in medicines regulation and to build the publics’ confidence in the Authority’s processes. Publication of approved SmPC is an additional step towards ensuring that healthcare providers and patients get adequate information to enable correct use of medicines.
3. Additionally, the aim of TPARs is to make the general public and all our stakeholders aware of the evaluation processes and grounds for approving registration of medicinal products. TPARs will not include any proprietary or confidential information and consent from individual Marketing Authorization Holders will be sought prior to publishing on our website.
4. Please note that these documents shall be updated throughout the product’s life cycle as necessary. To access these documents please click here.
5. For more information, please contact the Authority.