EU Commits To Flexibility On EPI
EU Regulators Adopt Key Principles On Electronic Product Information
EU regulators have adopted key principles for using electronic product information for human medicines, which are now expected to be followed by all parties involved in developing and implementing ePI.
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The pharmaceutical industry is concerned that too much flexibility may result in a “fragmented and cost intensive implementation” of the EU electronic product information framework.
A multi-stakeholder workshop this month is expected to result in draft EU proposals on how to start disseminating product information in electronic formats.
Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.