This guide provides brief information for companies that would like a pre-meeting in connection with the submission of documentation for the single technology assessment of pharmaceuticals.
The pre-meetings are intended for guidance purposes and are not binding.
The Norwegian Medicines Agency expect the company to possess the necessary knowledge of the guidelines and to use the template for the submission of documentation.
The purpose of pre-meetings
The Norwegian Medicines Agency offers guidance in order to identify and discuss any uncertainties regarding the STA and decision-making process, and the preparation of documentation for the STA of a particular pharmaceutical. The intention with pre-meetings is to ensure that the documentation that will be submitted is improved and becomes more relevant, which can speed up assessment. Views put forward during pre-meetings are not binding. Assessment of a case will not normally commence until the actual documentation dossier has been received and formally accepted.
Procedure and time-frame
The pharmaceutical company must contact the Norwegian Medicines Agency and request a pre-meeting. The request should be sent to either email@example.com or firstname.lastname@example.org (depending on the relevant source of funding of the pharmaceutical) and not to an individual assessor at the Norwegian Medicines Agency.
The agenda for the meeting, with issues that are to be discussed with the Norwegian Medicines Agency, should be submitted no later than 1-2 weeks before the meeting. A list of participants should also be enclosed. Pre-meetings normally last about an hour.
Recommended format and content of the meeting
Pre-meetings should not be used simply to give a presentation of a product or a comprehensive description of clinical characteristics. Pre- meetings should focus on issues that you wish to discuss with the Norwegian Medicines Agency in accordance with the agenda. Documentation that is submitted in advance should contain information on PICO, with a discussion of the choices that you would like to make in connection with the preparation of documentation for single technology assessments, including:
- Patient group (P)
- Intervention (I) (including therapeutic position in Norwegian clinical practice)
- Comparator (C)
- Outcomes (O)
- Relevant studies
- Justification and choice of method for pharmacoeconomic analysis
No agreed minutes will be prepared for pre-meetings. The minutes are intended for internal use by the parties, but this does not preclude companies from submitting such minutes for information purposes.