Updated formatted table template for dossier submission available
NewsCorporate
All companies submitting procedural information to the European Medicines Agency are reminded to insert the 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 the information provided.
The new version takes the new procedures that were introduced as part of the implementation of the pharmacovigilance legislation into account.
All users should ensure that they use the updated version of the table which is available on the Marketing authorisation guidance documents.