This document provides answers to questions frequently asked by stakeholders related to Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (‘the HTA Regulation’).
Any views expressed in this document are the preliminary views of the European Commission (EC) services and may not under any circumstances be regarded as stating an official position of the EC.
The information transmitted intends to clarify the provisions of the HTA Regulation. Only the Court of Justice of the European Union is
competent to authoritatively interpret EU law.
These FAQ are based on enquiries received and will be regularly updated.
The HTA Regulation is available at:
https://eur-lex.europa.eu/eli/reg/2021/2282/oj