Scientific advice by the national and European approval 2025

1. Click ‘Get Form’ to open it in the editor.
2. Begin by filling out the 'Antragsteller / Applicant' section. Enter your name, date, company or institution, address, contact person details including title, department, phone number, and email.
3. In the 'Arzneimittelbereich / Area of medicinal product' section, select the relevant category for your medicinal product from options like Advanced Therapy Medicinal Product (ATMP) or Antibodies.
4. Provide information regarding 'Joint Scientific Advice' by indicating consent for forwarding submitted information to the G-BA.
5. Fill in details about the medicinal product including its name, active substances, therapeutic indication, and a brief description of key manufacturing steps and mode of action.
6. Outline the scope of scientific advice needed by selecting relevant topics such as Quality or Clinical aspects.
7. Propose at least three preferred dates for the meeting and indicate the number of participants.
8. Complete formal aspects regarding manufacturing licenses and previous regulatory consultations if applicable.

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