Type IA Annual Updates

Under the Delegated Regulation (EU) 2024/1701, the submission of Type IA Annual Updates became mandatory across the European Union as of 1 January 2025. The European Commission’s detailed guidance on the revised variations framework shall apply from 15 January 2026.

What is a Type IA Annual Update?

The Annual Update is one submission that covers all Type IA changes made to a Marketing Authorisation in the past 9–12 months.

The date the change is implemented in the Marketing Authorisation Holder's (MAH) quality management system is the reference point for applying the current/new Variations Guidelines. This is different from Type IB/II variations, where the submission date is used.

When submitting an Annual Update, applicants should:

  • Wait at least 9 months from the date of the first Type IA change 
  • Submit one Annual Update covering all Type IA changes made in the past 9–12 months
  • Include a Type IAIN only when you submit the Annual Update immediately after implementing the Type IAIN

Applicants should not:

  • Include changes older than 12 months (you must file these separately as Type IB).

Example: If a company makes three Type IA changes on 10 March 2026, 5 May 2026, and 23 June 2026, the Annual Update for these changes must be submitted between 10 December 2026 and 9 March 2027.

What is the difference between a Type IA Annual Update and a Super Group? 

The table below highlights the key differences between a Type IA Annual Update and a Supergroup.

Feature

Type IA Annual Update

Super-group

Number of MAs involved

One MA

Multiple MAs

Basis of grouping

Variation(s) implemented over time

Variation(s) implemented across multiple MA's

Submission timeframe

9-12 months after variation implementation

Anytime

Variation type

Type IA and Type IAIN (if the Annual update is submitted immediately after implementation of the Type IAIN)

Type IA and/or IAIN(immediate notifications can be included if relevant)

Further information can be found on the CMDh website.

What should applicants do if they have changes made before 15 January 2026? 

CMDh guidance for the transition to Annual Updates (Type IA):

Type IA changes made before 15 January 2026  must be submitted before 15 January 2026 using the current electronic Application Form. If no Annual Update is due before that date, the MAH should submit these changes either: as part of an earlier Annual Update, or as individual notifications outside the Annual Update.

What should applicants do if they have changes made after the 15 January 2026?

Type IA changes made on or after 15 January 2026, the first Type IA change implemented on or after 15 January 2026 will begin a new Annual Update cycle. Exceptions apply if the change falls under one of the listed Annual Update exemptions.

Does the introduction of the Annual Update impact receipt and validation?

To ensure validation of your Annual Update submission, complete the following actions: 

CESP

  • Send the application through CESP using the standard process.
  • Add the description “Annual Update” in the free text sections.
  • Submit each sequence separately — do not combine multiple sequences in one submission.

Cover letter

  • Use the CMDh/096/2009, Rev.8 cover letter template
  • Ensure to tick the box for Annual Update in the relevant section 

Completed application form

  • Use the latest electronic Application Form.
  • If relevant, complete both the current (present) and proposed sections to show exactly what is changing.
  • Attach any supporting documents required for the variation category.

Proof of payment

  • If Ireland is the Reference Member State in a Mutual Recognition procedure, a small administrative fee applies to Type IA variations.
  • Check the fee section of our website for the fee code and payment details.