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 type | To be submitted no later than | Reason |
|---|---|---|
| Type IA and Type IAIN | Tuesday 30 November 2021 | To 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 2021 | Submission 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