Referral procedures: Regulatory and procedural guidance

Referrals: general

• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
• Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
• Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
• Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use
• Notice to Applicants, volume 2A, Procedures for marketing authorisation, Chapter 3 Union Referral Procedures
• Q&A: Urgent Union Procedures (Art.107i)
• Q&A: Article 20 pharmacovigilance procedures
• Q&A: Article 20 non-pharmacovigilance procedures
• Q&A: Article 31 pharmacovigilance referrals
• Q&A: Article 31 non-pharmacovigilance referrals
• Q&A: Article 29(4) referral procedures
• Q&A: Article 13 referral procedures
• Q&A: Article 30 referral procedures
• Committee for Medicinal Products for Human Use (CHMP)
• CHMP members
• CHMP meeting highlights
• CHMP: Working parties and other groups
• Pharmacovigilance Risk Assessment Committee (PRAC)
• PRAC members
• PRAC meeting highlights
• Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)
• Guideline on the definition of a potential serious risk to public health in the context of Directive 2001/83/EC
• Annex to the Guideline on the definition of a potential serious risk to public health in the context of Directive 2001/83/EC
• CMD(h) Referrals webpage
• CMDh questions & answers CMDh referrals
• CMDh annotated QRD template for MRP/DCP
• Guideline on the readability of the labelling and package leaflet of medicinal products
• What EMA publishes and when - Guide to information on human medicines evaluated by EMA
• Fees payable to the European Medicines Agency
• Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency
• Procedural Advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62(1) of Regulation (EC) No 726/2004
• Guidance to applicants /Marketing Authorisation Holders (MAHs) on oral explanations at EMA
• Public hearings | European Medicines Agency (europa.eu)
• Procedural Advice for CHMP on the need to convene a Scientific Advisory Group (SAG) or Ad Hoc Expert Meeting
• Post-authorisation safety studies (PASS)
• Post-authorisation efficacy studies (PAES): questions and answers
• Direct healthcare professional communications
• Procedural advice on the re-examination of CHMP opinions
• Notice to Applicants, Volume 2A, Procedures for marketing authorisation, Chapter 6 Decision Making Procedure for the adoption of Commission Decisions, November 2005
• CMDh Recommendation for implementation of Commission Decisions or CMDh agreements following Union referral procedures where the marketing authorisation is maintained or varied
• CMDh questions & answers post referrals phase

Referral submissions

• Dossier requirements for centrally authorised products (CAPs)
• Dossier requirements for referral procedures and nationally authorised products
• eSubmission website
• eSubmission Gateway and Web Client
• XML delivery files use for all submissions via the eSubmission Gateway and the eSubmission Gateway Web Client
• EMA Service Desk portal
• IRIS: A secure online platform for handling product-related scientific and regulatory procedures with EMA

Guidance for timetables

• Timetable: Safety referral (Article 107i, urgent Union procedure)
• Timetable: Safety referrals (Article 20 and Article 31PhV)
• Timetable: Non-safety referrals

Committee meeting dates

• Upcoming meeting dates for the Committee for Medicinal Products for Human Use (CHMP)
• Upcoming meeting dates for the Pharmacovigilance Risk Assessment Committee (PRAC)
• Upcoming meeting dates for the Mutual Recognition and Decentralised Procedures - Human (CMDh)

Transfer of MA, change of name, contact person and product withdrawal

• Transfer of marketing authorisation: questions and answers
• Changing the (invented) name of a centrally authorised medicine: questions and answers
• Notifying EMA of changes to contact persons
• Notifying a change of marketing status
• Procedural advice on publication of information on withdrawals of applications

Referral product information and translations

Practical information on translations for referral procedures (human)

Reference Number: EMA/583202/2012 Rev. 1Summary:

A linguistic review of product information in all EU languages is performed after adoption of CHMP opinions / CMDh position/agreement to ensure high quality and consistent product information. Such product information linguistic review is part of the Commission Decision-Making Process (DMP) as outlined in Articles 9 and 10, and Articles 34 and 35 of Regulation (EC) No 726/2004, as well as in Articles 20 and 23 of Regulation (EC) No 1234/2008, as applicable.

• Product information templates for referral procedures
• Annex A templates - see QRD templates section
• QRD form 2
• Product information requirements