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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]

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