All companies submitting procedural information to the European Medicines Agency are reminded to insert the updated formatted table template in their cover letter.

The formatted table template is used by companies when they submit information on a medicine to the Agency. It is intended to systematically structure and label information provided.

The new version is taking into account the new procedures that were introduced as part of the implementation of the pharmacovigilance legislation.

All users should ensure that they use the updated version of the table which is available at the Dossier Submission: Regulatory and procedural guidance page.


Posted on the EMA website on 24 January 2013