Is responsible for the authorization of medicines / medical devices and for ensuring that
The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide guidance on a specific project.
Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.
Products selected for this pathway will have an EDC composed of the EDWP members and up to 3 additional HTABs. Once the decision to proceed with a Consolidated Parallel Consultation has been taken, the EUnetHTA ED Secretariat begins the process of recruiting additional HTABs to compose the EDC.
The Early Dialogue Committee (EDC) is constituted for a specific product and the members will fluctuate to a degree for each Consultation. In the case of Consolidated Parallel Consultations, all EDWP members and a maximum of 3 other HTA members (from EUnetHTA WP5) will participate.
The Early Dialogues Working Party (EDWP) is a standing committee established by EUnetHTA to ensure robust high-quality HTA outputs. All EDWP members will participate in procedures selected for Consolidated Parallel Consultation.
Regional and national HTA bodies provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular Member State or region.