All European Commission articles
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Industry newsNovel antibiotic receives EMA’s recommendation
The European Medicines Agency has recommended marketing authorisation for an antibiotic which can treat multidrug-resistant infections.
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JournalTransition to the new QRD template for veterinary medicines: challenges and opportunities
The product information template version 9 (QRD v.9) supports the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6[1] (VMR), which has applied since 28 January 2022. Considering the high workload and costs associated with the quality review document (QRD) updates, the huge number of veterinary medicinal products (VMPs) concerned, ...
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Industry newsMHRA publishes ‘recognition route’ revised guidance
The MHRA has issued guidance on its International Recognition Procedure, which will replace the EC Decision Reliance Procedure from January 2024.