European Medicines Agency - Human Medicines - Referrals - Article 29 - 'mutual recognition' referrals

Human Medicines - Referrals
List of Referrals - Article 29 - 'disagreement between member states on an application'

Background
Article 29 of Directive 2001/83/EC as amended referrals are referrals that take place during the mutual recognition or decentralised procedure, when there is a disagreement among Member States on whether or not the authorisation should be granted. Such a referral starts when ‘one Member State cannot approve [the authorisation] on the grounds of potential serious risk to public health’ (article 29(1)).

Prior to 2001, this type of referral was known as an article 10 referral (referring to article 10 of Council Directive 75/319/EEC as amended).

At the end of the referral, the CHMP opinion will contain a recommendation on whether or not the marketing authorisation should be granted. When the Committee recommends the granting of the authorisation, this is 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.

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European Medicines Agency - Human Medicines - Referrals - Article 29 - 'mutual recognition' referrals