Referral: EU-level assessment of a disputed or safety issue
A referral is an EU procedure that resolves a scientific or regulatory issue about a medicine, or a class of medicines, in a single EU-level assessment.
Referrals have several legal bases: Article 29(4) of Directive 2001/83/EC for disagreements in MRP or DCP, Article 30 to harmonise divergent national decisions, Article 31 for questions of Union interest, Article 107i for urgent safety issues, and Article 20 of Regulation (EC) No 726/2004 for centrally authorised products. The CHMP or PRAC assesses the issue, and the outcome applies across the EU.
Problems: underestimating how quickly product information must change after the decision, and missing that a referral on one product can change the labelling of every generic of the same substance.
Timing
In an Article 29 disagreement the CMDh has 60 days to reach agreement. If it fails, the CHMP gives an opinion within 60 days, extendable by up to 90 days. Other referrals follow a timetable adopted at the start, often with clock-stops for holder responses. A Commission decision, or for some safety referrals a CMDh position, follows, and holders must vary their authorisations within the deadline it sets.
Used in
When an outcome is published, assess what a referral outcome means for your portfolio in the portfolio monitoring workflow.
Related terms
- MRP: mutual recognition procedureThe mutual recognition procedure (MRP) extends a national marketing authorisation from one EU/EEA Member State to others, which recognise it.
- PSUR: periodic safety update reportA periodic safety update report (PSUR) is a holder's periodic benefit-risk evaluation of a medicine, due at intervals set by the EURD list or the MA.
- Article 30 referral: harmonisation of divergent national authorisationsAn Article 30 referral asks the CHMP to harmonise the product information of a medicine authorised nationally on differing terms across Member States.
- Article 31 referral: referral in the interest of the UnionAn Article 31 referral is an EU-level assessment of a medicine or class of medicines where the interests of the Union are involved, usually on safety.
- CMDh: Co-ordination Group for Mutual Recognition and Decentralised ProceduresThe CMDh is the group of national authority representatives that resolves disagreements in MRP and DCP and coordinates nationally authorised medicines.
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