Pharmacovigilance

Instructions to marketing authorisation holders for application of variations after referral

The application of variations that are result of a referral should be carried out according to the following guideline: Recommendation for implementation of Commission Decisions or CMDh agreements following union referral procedures where the marketing authorisation is maintained or varied (Doc. Ref.: CMDh/318/2014, September 2014), accessible here.

Variations should be classified according to the current guidelines in the European Union: 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 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures (May 2013), accessible here.

Variations to the appropriate sections of the Summary of Product Characteristics , package Leaflet and Labelling that are result of a referral procedure are classified as C.I.1.a. C.I.1.b and C.I.1.c.

In case of C.I.1.a described in the guideline on variation classification, if a variation of a referral procedure requires an additional simplified adaption of appropriate sections of the summary of Product Characteristics and/or package leaflet (i.e. deletion of statements that are contradictory to the listed variation, minor linguistic changes, changes of phrase constructions and generally formatting of sections or topics), the variation should be notified as IB variation as it does not fulfil the stipulated condition for a IAIN variation.

If a referral procedure finishes with a Commission's decision, changes of the appropriate sections of the Summary of Product Characteristics, Package Leaflet and Labelling must be identical to those indicated in the Annex III of the implementing Commission's Decision. Marketing authorisation holders for medicines indicated in the Commission's decision are required to notify the appropriate changes within 10 days of the Commission's Decision. In case that the decision on referral is adopted unanimously in the Co-ordination Group for MRP/DCP (CMDh), the marketing authorisation holders to which the referral applied are required to notify the appropriate changes according to the deadlines indicated in the CMDh's Decision.

For medicinal products not indicated in the referral Decision, but containing the same active substance, marketing authorisation holders are required to apply for an appropriate variation in accordance with the Recommendation for implementation of Commission Decisions or CMDh agreements following union referral procedures where the marketing authorisation is maintained od varied (Doc. Ref.: CMDh/318/2014, Speptember 2014) (the Decision on a referral should be implemented no later than 90 days from the endorsement of a legally binding decision for EU Member States).

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