EMA have released a new pre-submission variations checklist

A new pre-submission checklist has been published for Type II variations. The European Medicines Agency (EMA) has a handy set of checklists to help Marketing Authorisation Holders (MAHs) enhance the quality of their submissions for variations and renewals.

The EMA encourages the use of these checklists to help avoid mistakes and missing documentation, and ensure that applications comply with the requirements – both regulatory and legal. By using the checklists, submissions should be validated more quickly and go to assessment sooner. If, however, any other issues arise during the EMA’s review, than this could cause a delay or influence the outcome of the validation/assessment.

To see the new pre-submission checklist for Type II variations, click here.

For all other variations and renewals, click here.