Centralised procedure variations: the source map for MAHs

Separate classification from procedure

The Variations Regulation and Classification Guideline establish the legal and classification framework. EMA post-authorisation guidance then explains how centrally authorised products are handled operationally, including Type IA, Type IB, Type II, grouping, worksharing and extensions.

A procedure plan should cite both levels. An EMA operational instruction does not replace the legal classification source, and a classification code alone does not answer every submission question.

Check the current EMA operating route

EMA states that MAHs should use IRIS to manage variations and extensions after the original submission, while the submission gateway continues to serve a different function. Confirm the current EMA instructions, forms and product-specific contacts before dispatch.

• Confirm the variation category, scope and affected marketing authorisations.
• Check whether grouping or mandatory worksharing applies.
• Reconcile application data, IRIS procedure data and the eCTD sequence.
• Include updated product information, translations and supporting summaries where required.
• Record the EMA guidance revision and access date in the submission plan.

Keep sources current at the point of use

EMA post-authorisation pages and consolidated procedural advice are updated regularly. Use the live topic page as the entry point, then verify that downloaded documents and internal SOPs match its latest revision.

Qualified review remains necessary for the product facts, regulatory strategy, classification and final application content.