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01.07.2025
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Advice
The new application form for advice has been online since July 1, 2025. It bundles all advice procedures offered by BfArM and Paul-Ehrlich-Institut on a central platform.
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20.05.2025
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Agenda Iris User Group Meeting
Agenda Iris User Group Meeting
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30.06.2025
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Agenda: PDU-Workshop
Path(s) to transform your research into a product candidate
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27.06.2025
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Angusta (misoprostol for induction of labour): Reports of overdose and contraindicated use with labour already in progress
Active substance: misoprostol
Reminder of the authorisation-compliant application.
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20.06.2025
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Approval procedure pursuant to Section 31 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025
The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.
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12.09.2025
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Azithromycin: re-evaluation of the benefits and risks
Active substance: azithromycin
The European Commission's final decision on the risk assessment procedure for azithromycin has been published.
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15.10.2025
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BfArM meets Europe: Shaping the EHDS
BfArM meets Europe: Shaping the EHDS - 24 – 25 November 2025
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11.07.2025
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CAMD and HMA: European medical device competent authorities statement on reform of the EU regulatory framework for medical devices (July 2025)
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18.06.2025
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Capacity building at its best: seeding and harvesting
This report highlights two key milestones: the recent manual workshop in Tanzania and the first continental clinical assessment training – both of which underscore the fellowship's commitment to capacity-building and harmonization across the African continent.
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22.09.2025
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Causes of death coding in Iris with ICD-11 testing results
Causes of death coding in Iris with ICD-11 testing results
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12.05.2025
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CHMP Committee for Medicinal Products for Human Use
CHMP Meeting Highlights for July 2025
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12.05.2025
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CHMP Meeting Highlights April 2025
CHMP Meeting Highlights April 2025
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16.06.2025
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CHMP Meeting Highlights July 2025
CHMP Meeting Highlights July 2025
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16.06.2025
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CHMP Meeting Highlights June 2025
CHMP Meeting Highlights June 2025
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09.05.2025
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CHMP Meeting Highlights March 2025
CHMP Meeting Highlights March 2025
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16.06.2025
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CHMP Meeting Highlights May 2025
CHMP Meeting Highlights May 2025
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24.10.2025
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Code-Search
Code-Search
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24.07.2025
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Code-Search: ICD-10-GM online
Code-Search
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01.10.2025
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Comments concerning texts published in Issue 12.2
Comments concerning texts published in Issue 12.2
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27.10.2025
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Current processing statistics of the BfArM
State: September 2025
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