Referral Art. 30 and 31 (non-pharmacovigilance)

Referral decisions and new product information changes can be found on:

  • the European Commission website - (EU languages only) this includes (Union) referral procedures (in accordance with articles 29(4); 30; 31(1); 31(2) or 107i of Directive 2001/83.
  • EMA website – (EU and EEA languages) all procedures, including CMDh positions on PRAC (Union) referrals for solely nationally authorised products (including MRP/DCP products) for which there is consensus within the CMDh

All European Commission decisions from the last 6 months can be find at EC website

More information on referrals can be found at EMA website


Harmonisation of SmPC – Article 30 Referrals

Information on applications referred in accordance with Article 30 of Directive 2001/83/EC