EMA provides guidance to MAHs on last submission dates for Type I variations in 2021

The European Medicines Agency (EMA) has provided guidance to MAHs on last submission dates for Type I and II variations for human medicines, in 2021.

(MAHs) are advised to submit variations as follows:

Variation typeTo be submitted no later thanReason
Type IA and Type IAIN Tuesday 30 November 2021To enable EMA to acknowledge the validity of the submission before the Agency’s closure on 23rd December and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008
Any Type IB variations or groupings of Type IBs and type IAs Friday 3 December 2021Submission by 3 Dec 2021 is advised for a start of procedure in 2021.
For submissions received on or after 6 December 2021, the procedure may not start until January 2022.

The Agency will remain closed between 23 December 2021 and 3 January 2022.

For procedural or regulatory queries related to these procedures, MAHs for human medicines can raise a ticket via the EMA Service Desk, using the Question option. The Type of question to be selected is “Post-authorisation queries”, followed by sub-option “Variation IA” or “Variation IB A&B scopes” or “Variation IB C scopes”. 

Guidance is also provided on submission dates for veterinary medicines.

Source: EMA website