The Spanish Agency of Medicines and Medical Devices (AEMPS) has announced that it will no longer issue formal decision communications for Type IA/IAin variations in European procedures where Spain acts as the Concerned Member State (CMS).
This measure is aligned with the applicable European legislation and guidance governing Type IA/IAin variations. Under these provisions, it is the responsibility of the Reference Member State (RMS) to communicate to the Marketing Authorisation Holder (MAH) whether the submitted notification has been accepted or rejected.
Effective 10 June 2026, AEMPS has ceased issuing formal decision communications for these procedures. In addition, where a Type IA/IAin variation is rejected by the RMS, AEMPS will no longer implement the corresponding changes in the medicinal product history or carry out any actions related to the rejected variation.
The Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No. 1234/2008, concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use, state in section 2.1.2 (“Examination of Type IA minor variations under mutual recognition and purely national procedures”) that the Reference Member State or the competent authority of a Member State shall inform the Marketing Authorisation Holder and, where appropriate, the Concerned Member States of the outcome of its assessment.
In addition, the CMDh Best Practice Guide – Chapter 3: Processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure specifies that Type IA/IAin variations do not require a separate communication from the Concerned Member States to the Marketing Authorisation Holder. The responsibility for notifying the acceptance or rejection of the submitted variation lies solely with the Reference Member State.
Accordingly, when Spain acts as the Concerned Member State (CMS) in these procedures, AEMPS will no longer issue a formal decision communication to the Marketing Authorisation Holder. Furthermore, where the RMS rejects a variation, AEMPS will neither implement the related changes in the medicinal product record nor carry out any actions associated with the rejected variation. Read the original communication here: La AEMPS deja de emitir la comunicación de la decisión de variaciones IA/IAin en procedimientos europeos en los que sea RMS
At Asphalion, we can support you throughout the preparation, submission, and management of your variations, ensuring compliance with the latest regulatory requirements.
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