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Changes to the Submission Process for Documentation in Health Technology Assessments from September 1st

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Changes

From September 1st 2025, companies must notify the Norwegian Medical Products Agency (NOMA) at least three months prior to submitting documentation. An information meeting regarding these changes will be held on August 22nd.

Early notification from companies makes it easier to recruit medical experts before the assessment process begins. This notification also helps with resource planning, enabling the assessment process to begin immediately after the documentation has been submitted. 

The changes will come into effect on September 1st 2025 and will apply to medicines under both the general reimbursement scheme and the New Methods system (hospital medicines). 

See detailed information about the changes

Information meeting on August 22nd

NOMA will host an information meeting in Norwegian for the industry and other stakeholders on Friday, August 22nd at 9:00 AM. During the meeting, the changes to the process will be presented, and questions will be addressed. Registration deadline: August 15th.

Registration form (in Norwegian)

Positive Experiences

NOMA announced the changes on February 4th. Initial cases involving this notification process have demonstrated very positive results. 

“We see that predictability leads to more efficient use of time. We can plan and utilise our expertise more effectively, and we have more time to recruit medical experts so that work can begin as soon as we receive the documentation,” says Einar Andreassen, Strategic Director, Department for health economics and analysis. 

Consultation Process

On May 9th, NOMA invited stakeholders to provide feedback on the proposed changes. 

“We find that companies are also engaged in this and want more efficient processes. We are doing this to enable quicker decision-making, which is a shared goal for both us and the suppliers,” says Andreassen.

At the planned information meeting on August 22nd, NOMA will present the most important external feedback received regarding the changes. NOMA will also explain how this feedback has been assessed.