Regulatory information - Committee chairs' handwritten signatures no longer included in opinion documents from March 2015

News 20/02/2015

Change expected to streamline processes

The European Medicines Agency has decided that the chairs of its scientific committees and coordination groups will no longer have to sign the opinion documents. These signatures are not required by law. This change is expected to streamline the processing of opinions documents and will come into effect from 1 March 2015.

The cover letters accompanying the opinions, where applicable, will no longer have signatures either. They will include instead a statement indicating that the document has been approved.

The opinion documentation will continue to be sent to the applicants/marketing authorisation holders via the routes currently in place. It will be the replica of the electronic copy sent simultaneously to the European Commission, where applicable, and of the electronic copy retained at the Agency, marked as un-modifiable according to the Agency's Records Management Policy.

This process improvement involves only opinion documents (including recommendations, positions/agreements). Divergent positions, if any, will continue to be signed as per current practice.

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