Referral procedures: Regulatory and procedural guidance

Referrals

Procedural advice to CHMP members

AdoptedReference Number: EMEA/361945/2007

• 'Union Referral' the Rules governing Medicinal Products in the European Union, Notice to Applicants, Volume 2A, Chapter 3
• Guideline on the definition of a potential serious risk to public health in the context of Directive 2001/83/EC
• Article 29(1) and (2) of Directive 2001/83/EC
• CMD(h) Referrals webpage
• Recommendation for implementation of Commission Decisions or CMDh agreements following Union Referrals
• Q&A: Urgent Union Procedures (Art.107i)
• Q&A: Article 13 referral procedures
• Q&A: Article 20 pharmacovigilance procedures
• Q&A: Article 20 non-pharmacovigilance procedures
• Q&A: Article 29(4) referral procedures
• Q&A: Article 30 referral procedures
• Q&A: Article 31 pharmacovigilance referrals
• Q&A: Article 31 non-pharmacovigilance referrals
• Committee for Medicinal Products for Human Use (CHMP)
• Pharmacovigilance Risk Assessment Committee (PRAC)

Referral submissions

Dossier requirements for nationally authorised products (referral, PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device

Reference Number: EMA/13015/2014 Rev. 10

• eSubmission Gateway and web client
• Timetable: Safety referral (Article 107i, urgent Union procedure)
• Timetable: Safety referral (Article-20 and Article-31 pharmacovigilance)
• Timetable: Non-safety referrals
• Meeting dates for the Committee for Medicinal Products for Human Use (CHMP)
• Meeting dates for the Pharmacovigilance Risk Assessment Committee (PRAC)
• Meeting dates for the Mutual Recognition and Decentralised Procedures - Human (CMDh)

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Referral product information

Mutual-recognition, decentralised and referral product-information template version 4.2

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