A new Annex, Annex III, has been included in version 6.3 of the Q&A guidance relating to CTR No 536/2014.


The new CTR NO 536/2014 deadline will enter into force on January 31, 2023, as will the Questions & Answers (Q&A) relating to it. In December 2022 the European Commission published version 6.3 of the Q&A guidance. Let us explain what the most important change in this updated Q&A is.

Annex III, a new addition to the Q&A, lists the websites of all European Economic Area (EEA) countries so that sponsors can find important information to submit high quality Part II documents as part of their clinical trial applications.

The table also includes email addresses for enquiries related to Part I and II. This new annex allows sponsors to find information relating to each country’s national requirements. It should prove helpful when sponsors find themselves confronted with divergent national requirements in EEA countries.

Are you fully prepared for the new CTR?

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