EMA issues advice on new procedural guidance

Published: 1-Aug-2013
Regulatory

The guidance comes into force on 4 August


The European Medicines Agency has released advice on new market approval applications procedures.

Coming into force on 4 August, these procedures include new rules for marketing authorisation applications, including risk management plans, and submitting studies to regulators; some new data previously submitted after a market permission has been secured will be filed as an application to change a market authorisation.

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