PHAROS user group New The IT-System PHAROS was introduced at AGES MEA in July 2013. Since then many industry users have used the online electronic services. AGES MEA wants to extend the functionalitie

Microsoft Word - L_I285_Guidance Notes _National Stockpiling Guidance notes for the notification of national stockpiling L_INS_VIE_EVEQ_I285_02 Valid from: 22.04.2025 1/22 Guidance notes for the notif

Referenced at:

• FAQ online Service
• National stockpiling
• FAQ National stockpiling
• FAQ National stockpiling
• FAQ National stockpiling

Further information and amendments to the product information in all EU languages are available on the EMA website.

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  Mustertext Acenocoumarol | 493 KB
• link
  Link to the EMA Website

Further information can be found in the CMDh minutes from february 2025.

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  Mustertext Levonorgestrel IUS | 631 KB
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  Link to the HMA Website

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

Further information and amendments to the product information in all EU languages are available on the EMA website.

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  Mustertext Busulfan | 498 KB
• link
  Link to the EMA Website

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.

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  Mustertext Capecitabin | 498 KB
• link
  Link to the European Commission`s Website

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

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:

• Scientific advice by BASG

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.