EMA: PIQ/QRD Pre-Opinion Review of Product Information for Referral Procedures and Article 29 Paediatric Procedures

The purpose of this document is to ensure a consistent and efficient approach to review the quality of English product information of referral procedures, in particular Articles 30 and 31 of Directive 2001/83/EC, Article 29 paediatric procedures of Regulation (EC) No 1901/2006 and Article 13 of Regulation (EC) No 1234/2008 in the pre-opinion phase.