What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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21/04/2025
Clinical trials of medicinal products Overview BASG fee schedule for clinical studies Withdrawal for technical reasons Information and training material BASG fee schedule for clinical studies As of 01
Busulfan New
PSUR-outcome
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15/04/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Capecitabine New
PSUR-outcome
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15/04/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
15/04/2025
Scientific advice by BASG New Scientific advice in the development of medicinal products The objective of such national scientific advices is to discuss with BASG scientific matters regarding the deve
15/04/2025
EU IN communication on SNSA transition to 2025 7th February 2025 Simultaneous National Scientific Advice (SNSA) - Continuation and further development during 2025 Since February 2020, the EU Innovatio
Referenced at:
Safety warnings
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Medical devices
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14/04/2025
The Federal Office for Safety in Health Care (BASG) has been informed that the manufacturer SEBBIN, which went bankrupt in March 2025, has no legal successor who continues to fulfil the manufacturer obligations arising from the Regulation (EU) 2017/745 on medical devices („MDR“), as amended.
10/04/2025
Referenced at:
CHMP Monthly News
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10/04/2025
Up-to-date information from the 24.03.-27.03.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Tobramycin (nebuliser solution) New
Additional template
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07/04/2025
Further information can be found in the CMDh minutes from february 2025.