EU Regulation on Health Technology Assessment (HTAR)

HTAR – Health Technology Assessment Regulation (HTAR) 2021/2282 will be implemented throughout the EEA, including Norway, from 12 January 2025.

What is covered by the regulation?

This date marks the beginning of a legally mandated European cooperation on health technology assessments of relative effectiveness and safety. These will be based on a dossier  with clinical documentation submitted to the European HTA Secretariat by the companies. The HTA Regulation establishes a framework and procedures for cooperation within the EEA on health technology assessments. It sets common rules for collaboration and communication, as well as the use of methods for joint clinical assessments of health technologies.

Read more about the regulation(External link).

The HTA Regulation does not affect national sovereignty over decisions related to pricing and reimbursement or national competencies regarding the management and financing of health services and treatments.

Health technology assessment is defined in the HTA Regulation as a scientific, evidence-based process that allows for the evaluation of the relative effectiveness of new or existing health technologies.

Proposal for implementation is out for consultation

HTAR is an EU regulation, and the entire text will be incorporated into Norwegian law without changes. The Ministry of Health and Care Services has put forward a proposal for the implementation of Regulation 2021/2282 on health technology assessments and the Implementing Regulation 2024/1381 for public consultation.

Read more about the consultation proposal(External link) (only in Norwegian).

Incorporating the HTA Regulation into Norwegian law does not affect Norway’s authority to draw its own conclusions in a Norwegian health technology assessment or to make decisions on the national use and public funding of health technologies.

A working group has been established to perform the necessary adaptations of the

Find updated information on the adaptation of the Nye metoder system here(External link).

Timeline for introduction

The system for joint clinical assessments will be introduced gradually. From 2025, it will be limited to medicinal products with new active substances for the treatment of cancer and advanced therapies (ATMP). A selection of medical devices will be assessed from 2026. From 2030, the cooperation will include joint clinical assessments of all medicinal products with a new active substance for which marketing authorization is sought, as well as selected medical devices. Additionally, extensions of indications for already approved medicinal products will be included.

Find more information on the implementation of the HTA Regulation at the EU level here(External link).

This page will be updated with more information throughout autumn and winter 2024. The short address for this page is dmp.no/en/htar.