This applies to
However, it is clearly understood, that the legal requirements of the EU take precedence over scientific or technical guidelines. Therefore, the definition ECs and their reporting categories must comply with EU Variation Regulation(EC) No1234/2008 and the associated guidelines. As far as PLCM documents are concerned, if submitted, they currently cannot be recognised in the EU.
Irrespective of this, the concepts in ICH Q12, which are not foreseen in the EU regulatory framework will be further reviewed. The European Commission, together with the EMA and the National Competent Authorities, will continue to work on the implementation of ICH Q12 within the existing EU legal framework.
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