Scientific and regulatory advice

Scope of the advice

The MEB can advise on medicines, medical devices containing a supporting pharmaceutical substance and herbal medicinal products. This advice can relate to the regulatory or scientific strategy for all sections of the authorisation dossier: chemical pharmaceutical, pharmacological toxicological/pre-clinical, pharmacokinetic, clinical, or pharmacovigilance. It can also cover the entire product cycle: from the pre-clinical research phase to post-marketing change proposals.

Your questions may concern the design of a proposed study or production process, the legal basis of an application, for herbal medicines, the way in which European herbal monographs can play a role in the assessment, or the way in which traditional usage is assessed. Advice on the need for animal testing during the medicine development phase is also possible. The MEB can only respond to requests that relate to the (future) authorisation of your product.

Scientific advice can never be a substitute for an application for marketing authorisation and the advice provided has no bearing on the final assessment of the MEB and/or the CHMP. The MEB will not carry out a (preliminary) assessment of results or data outside the context of the dossier as a whole or attach any conclusion to it. The MEB will not make a decision on the benefit-risk balance.

Neither can the MEB answer any medical-ethical questions. These fall under the remit of the Central Committee on Research Involving Human Subjects (CCMO) or local medical ethics review committees.

Who is the advice for?

Any party involved in the development of a medicinal product may request scientific and/or regulatory advice. These range from large pharmaceutical companies to small (academic) research institutions. The MEB handles all data supplied in the strictest confidence.

Joint advice with the National Health Care Institute

As part of the same procedure, you can also request scientific advice from both the MEB (with respect to registration) and the National Health Care Institute (ZIN) (with respect to reimbursement). This may be relevant to the design of a clinical study (phase III), for example, so that it can meet the requirements for both authorisation and reimbursement. Both organisations are explicitly responsible for their own section of the advice, solely.

If you wish to make use of this procedure, you can add your question to the National Health Care Institute in the application form. All correspondence is directed via the MEB. We will notify you of whether the National Health Care Institute can participate in your request for advice. Under this procedure, you cannot ask the National Health Care Institute questions regarding pharmaco-economic research. You must submit such questions to the National Health Care Institute separately.

Simultaneous National Scientific Advice (SNSA)

The MEB has joined the SNSA pilot. Applicants can request scientific advice simultaneously at different member states. For more information, please refer to the website of the Heads of Medicines Agencies (HMA).

Categories and fees

Depending on the complexity of the question and the expertise required, the advice is divided into specific categories with corresponding fees.

Simple advice: regulatory advice, advice relating to the pharmaceutical or pre-clinical aspects of the medicinal product, or follow-up advice.

Partially multi-disciplinary scientific advice: purely clinical advice regarding the efficacy and safety of a medical product, whether or not in combination with pharmaceutical or pre-clinical, or a combination of pharmaceutical and pre-clinical advice.

Fully multi-disciplinary advice: advice relating to the clinical, pre-clinical and pharmacautical aspects of the medicine.

Customised advice: advice intented for start-ups, small businesses and adacemic groups. The advice primarily involves the pharmaceutical or pre-clinical aspects of a medicinal product in the early development phase (phase I of clinical research) or the development and authorisation of a new application for an existing medicine. You can also submit questions regarding the 'regulatory route map'. For tailored advice, there is the option of an exploratory preliminary consultation prior to the actual application.

National scientific advice timeslot application

To request a timeslot for a national scientific or regulatory advice you can use the Planning tool to support application for timeslots. The planning tool shows how many timeslots are available per month and for which department.

A time slot means that the request for advice can be submitted in that specific month. The time slot does not mean that the advice meeting will take place at that time, or that the advice letter will be sent in that specific month. See Application procedure below for more information.

After opening the planning tool, you can select a timeslot of your choice; a digital form will appear. You can then attach the completed and signed Request for timeslot for national scientific advice and enter your contact details.

To know to which department your request should be sent to, you can consult the organisational structure overview.

After submission you will receive a confirmation of receipt via e-mail. The MEB will inform you within three weeks following submission, whether the timeslot is assigned or not. The request for advice can be submitted to the MEB in the month of the time slot. See Application procedure below for more information.

Application procedure

Application procedure

You can request advice using the application form, where you can indicate which type of advice you think would be the most appropriate. It is important that you include specific questions and outline your own ideas regarding these questions.

On the form, you can choose oral advice or written advice. Written advice is generally provided in the case of less complex questions. Oral advice is intended to facilitate an effective exchange of ideas at a meeting which is held prior to the final advice. This gives both the applicant and the experts of the MEB the opportunity to ask further questions or provide further information on specific aspects. After the meeting, the MEB will provide a written answer to the questions.

The procedure for requesting advice is as follows:

• Complete and submit the application form. You will receive confirmation of receipt at the e-mail address specified. You can save the form during completion, if necessary.
• The application will be validated upon receipt of the application form. Within three weeks, you will be notified as to whether the application can be accepted. You will also be informed about the applicable fees.
• After confirmation by the MEB that the advice is granted, you will be sent an invoice. You must pay this invoice, also when you decide to cancel the request at a later stage.

Written advice:

• If your application is accepted, you are requested to send the relevant documentation via CESP or by e-mail to:case@cbg-meb.nl, including the case number for your application.
• You will receive the MEB's advice within 7 weeks of acceptance and receipt of the full set of documentation.

Oral advice:

• Once the application has been assessed, experts will be selected and a date for the meeting will be proposed. This date will be between 6 weeks and 3 months after the application has been accepted. Please bear this in mind when submitting your application.
• You are asked to send the relevant documentation, presentation, and list of attendees at least three weeks before the meeting via CESP or by e-mail to:case@cbg-meb.nl, including the case number for your application.
• The maximum duration for the meeting is 90 minutes.
• You are requested to write a report on the meeting and send this to the MEB no later than 2 weeks following the meeting. The report has no formal standing but provides the MEB insight into which clarification is needed for the definitive advice.
• The MEB aims to send the definitive advice within 4 weeks of the meeting.

Oral advice is not included in the fee for simple advice.

After the process has been completed

The final scientific advice is presented to the president of the Board and the National Scientific Advice Coordinator for their signatures. If the applicant still has questions after receiving the advice, further clarification may be requested regarding the advice issued, but the advice will not be reviewed again. If you would still like to discuss the advice with the MEB, you can request follow-up advice using the application form.

More information

For questions or further information regarding national scientific advice from the MEB, please feel free to contact us at nationalscientificadvice@cbg-meb.nl.

For questions regarding an application that has already been submitted, you can send an e-mail to case@cbg-meb.nl. Please include the relevant case number.