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The development of new medicinal products and medical devices including the monitoring of these products are subject to complex regulatory and scientific requirements. Within the scope of its competence, the BfArM provides support through various advice procedures.
Advice through the BfArM needs to be applied for in writing and is subject to fees with the exception of the Portfolio Meetings.
Detailed information is summarized in the respective Guidance for Applicants. In addition, these documents provide details on how to apply for advice and how these procedures are conducted as well as detailed guidance for filling-out the application form.