What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Mock-ups New
15/01/2026
Mock-ups New AT Guidance document – Mock-ups New This guidance document summarizes the legal basics and the BASG requirements with regards to the mock-ups of human and veterinary medicinal products th
Codeine/paracetamol New
PSUR-outcome
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15/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Safety warnings
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Medical devices
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12/01/2026
The Federal Office for Safety in Health Care (BASG) warns of a counterfeit medical device that could be mistaken for the legitimate product "Sculptra" from the manufacturer "Q-Med AB".
09/01/2026
Good manufacturing / distribution practices (GMP/GDP) Latest news Processing status Electronic submission Organisation Management Service (OMS) - Integration in EudraGMDP Information on inspection pre
Clomipramine New
PSUR-outcome
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09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Clozapine New
PSUR-outcome
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09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Varicella vaccine (live) New
PSUR-outcome
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09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Selegiline New
PSUR-outcome
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09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Rocuronium New
PSUR-outcome
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09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Rifampicin New
PSUR-outcome
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08/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.