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- Click ‘Get Form’ to open it in the editor.
- 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.
- 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.
- Provide information regarding 'Joint Scientific Advice' by indicating consent for forwarding submitted information to the G-BA.
- 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.
- Outline the scope of scientific advice needed by selecting relevant topics such as Quality or Clinical aspects.
- Propose at least three preferred dates for the meeting and indicate the number of participants.
- Complete formal aspects regarding manufacturing licenses and previous regulatory consultations if applicable.
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| 2013 | 4.3 Satisfied (35 Votes) |
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