Notification and process for submission of documentation for single technology assessments

The HTD must notify NOMA of the week number for submission of documentation for the health technology assessment (HTA) of medicines as early as possible, and at least three months in advance. 

 Example: If the company plans to submit documentation in week 49 (December 1–7), they must notify NOMA by September 1.  

This enables earlier recruitment of medical experts and facilitates NOMA’s internal planning so that the assessment can begin immediately after submission. 

If the HTD is unable to submit at the agreed time, they must inform NOMA as early as possible and no later than two weeks before the scheduled submission date. The HTD should explain the specific challenges or deficiencies, propose a new submission date, and provide a timeline for progress.  

Postponement may be considered if special circumstances prevent submission at the agreed time.  

NOMA will assess whether a short extension can be granted or if a new submission date must be set. NOMA will strive to agree on a suitable submission date together with the HTD. 

If documentation is not submitted on time, NOMA may lack the capacity to begin assessment immediately, and prioritization of cases may be necessary. 

NOMA begins recruiting medical experts once the HTD has notified them, so that recruitment can be completed by the time the assessment starts. NOMA may begin recruitment earlier if appropriate. 

NOMA encourages HTDs to request a pre-meeting if clarification is needed regarding documentation requirements. Pre-meetings and guidance may also be relevant if the company has questions about the eligibility assessment (for hospital medicines).  

NOMA will increasingly encourage pre-meetings where appropriate, already during the eligibility assessment (egnethetsvurdering) after the HTD request an assessment (anmodning). Guidance is also relevant if the HTD has questions regarding the eligibility assessment (egnethetsvurdering). Guidance is especially useful in cases where, for example, the eligibility assessment is unclear, the wording of the indication has changed from the original request, or the treatment area lacks clear national guidelines.  

Requests and eligibility assessments currently apply only to hospital medicines (under the “New Methods” system).  

Read more about pre-meetings here. 

NOMA will evaluate whether submitted documentation complies with pharmaceutical regulations and our own guidelines. Relevant requirements must be met for the submission to be accepted. The health technology developer (HTD) needs to justify any deviations from the guideline. 

If NOMA finds that the submission does not meet our guideline, we will notify the HTD and request changes. The HTD should respond without delay (within one week) indicating whether they intend to resubmit within reasonable time (10 business days). Our assessment only starts once we receive a complete submission. If the HTD cannot meet this deadline, a new submission date will be set. If NOMA does not assess within 10 business days (e.g., due to capacity issues), whether the submission meets our guideline, our processing of the case is considered to have commenced.

Read more about our guideline for submission.