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February 2, 2026
Approximately 5 minutes
BASG Guidance on National Scientific Advice (NASA) for Applicants in Austria
BASG Guidance on National Scientific Advice (NASA) for Applicants in Austria
1. Purpose and Scope
This guidance document provides applicants with detailed information on the operational procedure for National Scientific Advice (NASA) offered by the Austrian Federal Office for Safety in Health Care (BASG). NASA allows sponsors to discuss scientific matters related to the development of medicinal products with BASG experts. Source: BASG Guidance for Applicants on NASA https://www.basg.gv.at/fileadmin/redakteure/01_Formulare_Listen/B/L_B65_guidance_applicants_NASA.pdf
2. Types of Scientific Advice
NASA covers questions on quality, non-clinical, and clinical development, including regulatory strategy for marketing authorisation. It is available as standalone national advice or parallel with EMA scientific advice. Source: BASG Guidance for Applicants on NASA https://www.basg.gv.at/fileadmin/redakteure/01_Formulare_Listen/B/L_B65_guidance_applicants_NASA.pdf
3. Application Procedure
Applicants must submit a request using the specified form, including a briefing document with specific questions, proposed positions, and supporting data. Requests are submitted via email to the designated BASG contact. Source: BASG Guidance for Applicants on NASA https://www.basg.gv.at/fileadmin/redakteure/01_Formulare_Listen/B/L_B65_guidance_applicants_NASA.pdf
4. Timelines and Process
BASG confirms receipt and validates the request within defined periods. Meetings (virtual or in-person) are scheduled, followed by written advice. Timelines vary by type (standard or parallel with EMA). Source: BASG Guidance for Applicants on NASA https://www.basg.gv.at/fileadmin/redakteure/01_Formulare_Listen/B/L_B65_guidance_applicants_NASA.pdf
5. Fees
Fees apply based on the type and scope of advice requested. Reductions available for SMEs, orphans, or paediatric developments. Source: BASG Guidance for Applicants on NASA https://www.basg.gv.at/fileadmin/redakteure/01_Formulare_Listen/B/L_B65_guidance_applicants_NASA.pdf
6. Contact and Further Information
For submissions and questions, contact the BASG scientific advice team as indicated in the document. Source: BASG Guidance for Applicants on NASA https://www.basg.gv.at/fileadmin/redakteure/01_Formulare_Listen/B/L_B65_guidance_applicants_NASA.pdf
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