Medicinal Products

Instructions for Variation Application after Referral

Following the finalisation of the referral procedure, the Marketing authorisation holders should submit appropriate variation applications 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), available 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), available 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.

If the C.I.1.a variation requires additional adaption of appropriate sections of the Summary of Product Characteristics, Package Leaflet and/or labelling (e.g. deletion of the contradictory statements, minor linguistic changes, changes of sentence constructions, formatting of sections), the variation should be submitted as IB variation as it does not fulfil the set condition for a IAIN variation.

When the referral is followed by a Commission Decision, changes of the appropriate sections of the Summary of Product Characteristics, Package Leaflet and Labelling should be identical to those indicated in the Annex III of the implementing Commission Decision. Marketing authorisation holders for medicinal products covered by the defined scope of the Commission Decision should submit the appropriate variations within 10 days after the Commission Decision. In case that the referral is concluded by a CMDh agreement at CMDh (Co-ordination Group for MRP/DCP), the marketing authorisation holders for medicinal products covered by the defined scope of the referral should submit the appropriate variations according to the timetable for implementation as appended to the CMDh position.

For medicinal products not covered by the scope of the referral, but containing the same active substance, an appropriate variation should be submitted 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), available here.

Additional information about variation applications are available at CMDh webpage; Q&A; sections Variations.

The table below provides information on referrals relating to the medicinal products authorised in Croatia. The list includes decisions (EC or CMDh) made from 1st January 2020. Information on previously finalised referrals is available on the websites of the European Medicines Agency and the European Commission.

Date of EC Decision/CMDh Position Active Substance(s) Link to decision/position and related annexes
24 November 2020 ranitidine EC Decision
7 July 2020 fluorouracil (kapecitabin, tegafur, flucitozin) EC Decision
24 June 2020 leuprorelin CMDh Position
9 June 2020 fosfomicin EC Decision
25 March 2020 ciproteron CMDh Position
30 January 2020 estradiol CMDh Position

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