Referrals
- '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
- 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)
- Product information templates for referral procedures
- Annex A templates - see QRD templates section