European Medicines Agency - Human Medicines - Referrals - Article 30 - 'SPC harmonisation' referrals

Human Medicines - Referrals
List of Referrals - Article 30 - 'harmonisation' referrals
Background
Article 30 of Directive 2001/83/EC as amended states that ‘ if two or more applications …have been made for marketing authorisation for a particular medicinal product, and if Member States have adopted divergent decisions …, a Member State, the Commission or the applicant or the marketing authorisation holder may refer the matter to the CHMP’. The same article also makes provision for the coordination group (CMD) to propose a list on a yearly basis of products to be harmonised. See here for the current work list produced by the CMD(h).

Prior to 2001, this type of referral was known as an article 11 referral (referring to article 11 of Council Directive 75/319/EEC as amended).

At the end of the referral, the CHMP opinion will contain a recommendation for a harmonised set of prescribing information documents (SPC, labelling and package leaflet).

Medicinal products

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European Medicines Agency - Human Medicines - Referrals - Article 30 - 'SPC harmonisation' referrals