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EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations

Updated: Oct 17, 2022

Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for submitting type A and IB variations to the Centralised Procedure.

The General points that you need to consider when you are filling out the application form are:

  • It is important that the application form and cover letter are consistent.

  • Providing confusing or contradictory information can delay the procedure and must ensure that this is avoided.

  • In accordance with the Variations Guidelines, the changes in the section 'Precise scope' and the table 'Present and proposed' should be reflected under the Types of changes section, by their corresponding scope indent.

  • Product information - Do not submit Annex IV as part of the Product Information Annexes.

  • Make sure to include the filled and signed Product Information Annexes Checklist ( when the affected type of PI is involved; without this checklist, supplementary information will be requested and the process could be delayed.

  • Consult the EMA/CMDh explanatory notes on the Variation Application Form for further assistance.

To facilitate the application review, the following documents should be attached to the Application form:

  1. Letter of Authorization or Power of Attorney

  2. Any Document that do not fit into eCTD but can facilitate validation

Click this LINK to know in detail How to Fill the Application Form for Centralised Type IA and IB Variations.

Also, there was a Regulatory and procedural guideline released for public consultation: Data Quality Framework for EU medicines regulation describes the general considerations on data quality relevant to regulatory decision-making, as well as the dimensions, subdimensions, characterizations, and metrics associated with them.


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