Generics in MRP and DCP

List of MRP/DCP finalised in 2006-2010 with new active substances (November 2011)

CMDh Position paper on processing of generic applications when the generic has more indications or fewer indications than the reference product in the CMS (July 2014) [Track version]

Information to be submitted by the Member State of the European Reference Medicinal Product (March 2019) [Track version]

Standard form to be sent by the RMS to the MS of the ERP (March 2019)

CMDh Recommendations on implementation of Article 30 Decisions cf. Directive 2001/83/EC, as amended for Generic/Hybrid/Biosimilar Medicinal Products approved through MRP/DCP (July 2013) [Track version]