Referral procedures: Regulatory and procedural guidance
Table of contents
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Procedural advice to CHMP members (PDF/177.89 KB)
Adopted
First published: 06/08/2008
Last updated: 06/08/2008
EMEA/361945/2007 -
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Guidance to applicants/marketing authorisation holders on oral explanations at European Medicines Agency (PDF/88.26 KB)
First published: 16/04/2015
Last updated: 16/04/2015
EMA/748003/2014
- '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)
- eSubmission Gateway and web client
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Timetable: Safety referral (Article 107i, urgent Union procedure)
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Timetable: Safety referrals (Article 20 and Article 31PhV)
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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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Mutual-recognition, decentralised and referral product-information template version 4.2 (DOCX/41.62 KB)
First published: 30/08/2011
Last updated: 26/04/2021 -
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Practical information on translations for referral procedures (human) (PDF/1022.39 KB)
First published: 19/12/2012
Last updated: 28/11/2013
EMA/583202/2012 Rev. 1
- Product information templates for referral procedures
- Annex A templates - see QRD templates section