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Key principles for electronic product information implementation in EU released
The EC, EMA and HMA have published key principles on the various benefits of sharing medicinal product information electronically and how to implement this system.
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Heads of Medicines Agencies (HMA)
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Combatting drug shortages in the EU: new guidance
New guidance for marketing authorisation holders has been released by the EMA to reduce the impact of drug shortages in the EU. Maurits Lugard and Anna-Shari Melin at Sidley Austin discuss the document and highlight its main points.
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EU releases guidance for medicine shortages
The EU has issued two guidance documents intended to advise the pharmaceutical industry and patients during medicinal shortages.
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Clinical trial sponsors called to publish results on EU database
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.