Types of scientific advice
For the scientific advice, you select either a meeting or a written advice. Regulatory advice is usually provided in writing only. The meeting is intended primarily to achieve an effective exchange of (scientific) insights and gives both the applicant and the MEB experts the chance to ask follow-up questions or provide further information on specific points.
- Following receipt of the application form, the request will be assessed. Within 3 weeks you will be notified whether the request for advice has been accepted.
- If the request is approved, experts are selected and a meeting date is proposed. The meeting proposal is within 6 weeks and 3 months after approval of the request. The maximum duration of a meeting is 1.5 hours.
- You are requested to submit the relevant documentation for the meeting, including a list of those who are to attend, at least 3 weeks prior to the meeting. Please send it to email@example.com, referring to the case number. References do not need to be provided, but must be available on request.
- In case you make minutes of the meeting, you can send these to: firstname.lastname@example.org, referring to the case number, preferably within a week following the meeting. The minutes have no formal weight and you will receive no comments in reply. They do give the experts the opportunity to assess whether the definitive advice needs additional information.
- You will receive the MEB's advice within 4 weeks after the meeting.
In the event of written advice, the process is as follows:
- Following receipt of the application form, the request will be assessed. You will be informed within 3 weeks whether or not the application can be processed.
- If your request is approved, you will be asked to submit the documentation electronically to: email@example.com, stating the case number.
- You will receive the advice from the MEB within 7 weeks after acceptance and receipt of the complete documentation.
You can ask for further information about the advice provided, but this will not result in a new discussion. If you still wish to exchange ideas concerning the advice with the MEB, then you can submit a follow-up application. You can use the application forms on this page for this.
Applications for scientific and/or regulatory advice are initially evaluated by the internal advisory group for scientific advice.
The final scientific advice is submitted for signature to the Chair of the MEB and the Scientific Advice Coordinator.
Joint advice from the National Health Care Institute and the MEB
It is possible to request scientific advice simultaneously from both the MEB (for the purpose of marketing authorisation) and the National Health Care Institute (Zorginstituut Nederland, for the purpose of reimbursement) in one single procedure. This could be relevant for companies, for example when setting up a clinical study (phase 3), so that it can meet the guidelines for both marketing authorisation and reimbursement. Both organisations (MEB and National Health Care Institute) accept responsibility explicitly for their own part of the advice.
Questions concerning the pharmaco-economic study cannot be posed to the National Health Care Institute via this procedure. These questions should be submitted separately to the National Health Care Institute.
If you wish to make use of this procedure, please use the standard application form and add the specific question (including the applicant's point of view) to the National Health Care Institute. All further correspondence goes via the MEB.
Also in case you do not wish to make use of this procedure, it is possible that a representative of the Zorginstituut Nederland is present when your application or request for advice is discussed at the MEB.
Promoting innovation has a prominent place in the MEB Strategic Business Plan 2014-2018. As a result, as of 2015 a new form of scientific advice is offered: customised advice.
Customised advice is focussed especially on start-up companies, small companies and academic groups. In general, it will primarily concern the early phase of development (pharmaceutical or pre-clinical aspects, Phase I clinical research).
In some cases, studies in a later phase are eligible. For example, Drug Rediscovery may be a subject eligible for customised advice; the focus is here on the development and registration of a new application of an existing medicinal product. Furthermore, the advice concerns questions relating to the regulatory roadmap, e.g. towards Europe.
Customised advice has a reduced tariff. This tariff can also apply to a subsequent advice following an earlier customised advice. This makes advice over a longer trajectory possible.
Applying for customised advice follows a similar procedure as regular scientific advice. A request for customised advice can be stated in the application form.