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Revised RMP template mandatory as of 31 March 2018

Revised RMP template and transitional arrangements

On 30 March 2017, EMA published the second revision of the RMP template, which marketing authorisation holders and applicants can use for all RMP submission as of 31 March 2017.

Its use for all RMP submissions becomes mandatory as of 31 March 2018.

 

Guidance on the format of the risk management plan (RMP) in the EU – in integrated format

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