14.04.2015

EMA releases revision 48 of the Post-Authorisation Procedural Advice for Users of the CP

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A new revision 48 of the "Post-authorisation procedural advice for users of the centralised procedure" has been released by EMA this week.

The new revision now includes question and answer sections for each type of variation (type IA, type IB, type II) on which changes to an approved product will trigger new EU number(s) (additional presentation(s)) being issued. Corresponding examples for each variation type are given. 

As usual the Post-Authorisation procedural advice is available in "clean" and "track change" format from the EMA website.

[Source: EMA]

 

 

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