Scientific Advice and Pre-submission Meeting
Scientific Advice may be provided at any time before or after the initial authorisation of the medicinal product, and may cover a variety of questions related to the planning of the development programme.
Pre-submission Meetings are focused on questions related to planning and conduct of a concrete, forthcoming marketing authorisation application, for which the development programme is complete.
The object of the actual advice is the exact list of questions to be provided by the applicant. In addition, the applicant is requested to provide his position on each individual issue together with a justification. A more detailed documentation that is tailored for the list of questions has to be provided.
Furthermore, the BfArM offers so called Portfolio Meetings. These meetings provide the opportunity for pharmaceutical companies to present an overview of different development projects to the BfArM.
Detailed information about the various advice procedures are summarised in the "Guidance for Applicants“ together with details on how to apply for advice and how these procedures are conducted. In addition, this document provides detailed guidance for filling-out the application form.
In case of questions regarding advice procedures the following contact is provided:
Telefon: +49 (0)228 99 307-3958