Control of advertisement and product promotion of Medical Devices
Advertisement and Promotion of Regulated Products
Section 68 of the Tanzania Medicines and Medical Devices Act Cap.219 restricts the promotion and advertisement of medicines, medical devices, invitro diagnostics and biocidals unless approved by the Authority.
Control of Promotional & Advertisement Activities
- Starts during registration phase
- Approval of product labels
- Promotional materials and advertisements must be approved
- Trade exhibitions, Manufacturer sponsored symposium
- Public/patient disease awareness programs
Why we/TMDA regulate Promotional & Advertisement Activities
- To prevent dissemination of wrong information and exaggerated claims. Hence misleading the consumer regarding the safety, efficacy and performance
The Tanzania Medicines and Medical Devices (Control of Drugs and Herbal Drugs) Promotion, 2010
Requirements
- The product must be registered
- Detailed requirements on application for approval of advertisement and promotion of regulated product
When and how to apply
- Applications for approval can be made at any time before implementation of the advert
- Create a trader portal account
- Lodge an application online
- Processing is within 7 days
Incentives for registering orphan medicines
- Exemption from some provisions of the Fees and Chargers
- No application fees, no retention fees
- Expedited review within two months of orphan designation
- Technical assistance in meeting regulatory requirements
- Collaborative approach & real time communications regarding additional information and pending issues
- Pre-submission meetings
Limitations of marketing Orphan Medicines
- Only therapeutic indications related to orphan disease shall be approved
- Applicants may apply for separate marketing authorization for other non-orphan indications
- Registration is valid for 2 years after which renewal is required