European Medicines Agency - Human Medicines - Referrals - Referrals under Regulation (EC) 1084/2003 (article 5 or 6) - 'arbitration' referrals

Human Medicines - Referrals
List of Referrals - Referrals under Regulation (EC) 1084/2003 (article 5 or 6) - 'disagreement between member states on a variation'
Background
These referrals are triggered in the mutual recognition or decentralised procedure when there is a disagreement between Member States on a variation (change to a marketing authorisation) that is then referred to the CHMP for arbitration. Article 5 is used for disagreement on a type IB variation, article 6 for a disagreement on a type II variation.

Prior to 2001, these types of referral were known as article 7(5) referrals (referring to article 7(5) of Commission Regulation (EC) 541/95).

At the end of the referral, the CHMP opinion will contain a recommendation on whether or not the variation to the marketing authorisation should be authorised. This may be accompanied by a recommendation for the text of the SPC, package leaflet and labelling, and if appropriate, for the conditions to the marketing authorisation to ensure the safe and effective use of the medicine.

Medicinal products

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European Medicines Agency - Human Medicines - Referrals - Referrals under Regulation (EC) 1084/2003 (article 5 or 6) - 'arbitration' referrals