Application procedure advisory meetings

Scientific and/or regulatory advice

During the development of a medicinal product or an extension of a therapeutic indication, a company may request scientific or regulatory advice. The request for advice may relate to the scientific content of the dossier, and/or to the authorisation procedure to be followed.

Clarification meeting and hearing

In addition to routine contact between MEB case managers and the company during the course of an application procedure for marketing authorisation or subsequent amendment, there are two other possibilities for interaction:

• a clarification meeting, during which the company can request further clarification of the questions asked by the MEB
• a hearing, in the case that an intention of refusal of the application has been issued, or for MEB decisions the addressee is expected to object to. In a European application procedure this is also called a ‘break-out session’ or ‘oral explanation’.

Pre-submission meeting

During a European application procedure (Centralised procedure, Mutual Recognition or Decentralised procedure) with the Netherlands acting as Rapporteur or as Reference Member State (RMS), the company may request a pre-submission meeting with the MEB prior to initiating the application procedure. The purpose of this meeting is to discuss details regarding the procedure with the Rapporteur or RMS.

As these meetings do not qualify as scientific advice, no application form is required and you may contact the head of the Pharmacotherapeutic (PT) group in question directly.

Pipeline meeting

The MEB organises pipeline meetings 4 times per year. The purpose of this meeting is to inform the MEB on products for which an application is being prepared. The focus of a pipeline meeting is on 4 specific domains involved in the development/assessment of a new medicinal product:

• Indication
• Endpoint
• Potential patient population
• Therapeutic position

Preclinical and clinical aspects, pharmacovigilance and quality aspects can also be addressed during the meeting. Translational aspects are also discussed, from Proof of Concept/mechanism of action to clinical application.

A pipeline meeting is not a full summary of all upcoming applications; a maximum of 4 themes are discussed per meeting, with a focus on in-depth discussion rather than the broader view.

Companies may submit questions to the MEB during the pipeline meeting. These questions must be open in nature. After the presentation by the company, there must be sufficient time for discussion.

Products for which a Rapporteur has already been assigned are not discussed during this meeting. Questions already asked in an application for scientific advice are not discussed during a pipeline meeting.

For more information about the pipeline meeting you can contact the MEB's Policy, Regulatory and International Affairs unit via e-mail address BRI@cbg-meb.nl.