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EMA Procedural Advice: Recommendations on Unforeseen Variations

Earlier today (27 February 2023) European Medicine agency released an updated "Procedural Advice on Recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008".

According to Commission Regulation (EC) No 1234/2008, Annex II defines minor and major changes to marketing authorisations, while Annex I defines extensions.


According to Article 5 of the regulation, a marketing authorization holder or competent authority can request a recommendation from CMDh or EMA on a classification of an unforeseen variation.


As per this guidance, medicinal products for human use that have been authorised through the centralised procedure are covered, and requests shall only apply to variations whose classification is not contained in the annex or guideline (i.e. unforeseen variations). The EMA cannot “reclassify” a variation already listed in the annex/guideline.


A variation that falls under the scope of a foreseen variation, a recommendation that has already been issued or one that is clearly classified as a type IB by default according to the classification guideline will be reported to the MAH by the EMA.


The EMA will share the variation request with the CMDh for discussion if the variation is unclassified, in order to avoid any discrepancies in recommendations.


Click this LINK to know more about how to submit the request, and the opinions expressed by Member States and CHMP working parties in this procedure.

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