Control of Advertisement and Product Promotion
Promotion of Medicines is a means of creating awareness and disseminating information of medicines to healthcare professionals and general public through advertisement and promotional materials. Promotion if not carried out correctly, may pass the wrong information and portray unethical uses based on false and exaggerated claims. Promotion activities if not well regulated may pose threat to patient’s safety. This possess a health threat to the potential users as such advertisements containing misleading information on safety, quality and efficacy of products. Medicinal products promotion activities in Tanzania are done in accordance with;
- The Tanzania Medicines and Medical Devices Act, Cap 219
- Tanzania Medicines and Medical Devices (Control of Drugs and Herbal Drugs) Promotion Regulations,2010
- Guidelines for Control of Promotion and Advertisement of Medicines and medical Devices in Tanzania , 2015
- The National Drug Policy 1993
In line with the policy, law, regulations and guidelines cited above, TMDA regulates the following with respect to promotion activities: -
- Advertisements of medicines
- Manufacturer-sponsored symposia
- Trade shows
- Public/patient disease awareness programmes not related to any medicines
Promotion activities in the country takes place only with respect to products that have been registered by the TMDA and in that regard TMDA has the legal responsibility for regulating the labeling and advertising of products so that that customers are adequately safeguarded from false or misleading promotion. Advertisements and promotion materials for registered medicines are reviewed by TMDA before approval.
For application of registration of promotional material, submit dully filled in applications form (application form for approval of promortion and advertisement of medicines and medica devices in Tanzania) accompanied with prescribed information as detailed in the Guidelines for Control of Promotion and Advertisement of Medicines. The application should be accompanied with proof of up to date registration of the product and other requirements as detailed in the respective guidelines.
After approval, the applicant shall be issued with approval certificate with a validity period of two (2) years. As part of control, TMDA monitors all advertisements and promotional materials for medicines.
Importers intending to import promotional materials shall be required to apply for importation permit of promotional materials. The application should be accompanied with approval certificate of promotional materials issued by TMDA. To apply for import permit of promotional materials. Click here
For Regulations on control of drugs and herbal promotion Click here and for
For fees and charges Click here