Referral procedures are EU regulatory mechanisms used to resolve significant questions about a medicine or class of medicines, including safety and benefit-risk issues that require coordinated assessment across Member States.
Official resource
- EMA referral procedure repository — procedure pages, assessment documents, recommendations and outcomes.
Practical use
Use referral pages to establish the scope of an EU-wide review, identify the legal procedure and medicines involved, follow PRAC/CHMP/CMDh consideration where applicable, and retrieve the final regulatory outcome and supporting documents.
For pharmacovigilance governance, referrals are particularly important because their outcomes can trigger product-information changes, restrictions, suspensions, additional risk-minimisation measures, DHPCs or further studies. The referral page should therefore be read together with subsequent Commission decisions, CMDh positions or product-specific implementation material where applicable.