European Medicines Agency - Human Medicines - Referrals - Article 31 - 'community interest' referrals

Human Medicines - Referrals
List of Referrals - Article 31 - 'community interest' referrals
Background

Article 31 of Directive 2001/83/EC as amended states that ‘the Member States or the Commission or the applicant or the marketing authorisation holder shall, in specific cases where the interests of the Community are involved, refer the matter to the Committee … before any decision is reached on a request for a marketing authorisation or on the suspension or revocation of an authorisation …in particular to take account of the information collected in accordance with Title IX [pharmacovigilance]’.

This referral can also be triggered for a range of medicinal products or a therapeutic class.

Prior to 2001, this type of referral was known as an article 12 referral (referring to article 12 of Council Directive 75/319/EEC as amended).

At the end of the referral, the CHMP opinion may contain a recommendation for some changes to the prescribing information (such as the SPC wording). It can also contain some conditions to the marketing authorisation, to ensure that the safety of the medicine(s) is monitored appropriately. It can also recommend a suspension or withdrawal of the authorisation

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European Medicines Agency - Human Medicines - Referrals - Article 31 - 'community interest' referrals