Supplementary protection certificate for medicinal products

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Parere del CESE: Supplementary protection certificate for medicinal products

Key points


  • supports the proposed amendment of Regulation (EC) No 469/2009, proposing modifications in line with Option 4, i.e. legislation on both export and stockpiling waivers;
  • welcomes that this proposal leaves SPC protection intact as regards placing products on the EU market;
  • welcomes the market exclusivity of EU SPC holders in the Member States during the full period of SPC protection;
  • deems it to be most important that, on those non-EU markets where protection does not exist or has expired, there be fair competition for EU-based manufacturers who bring generics and biosimilars to these markets;
  • strongly supports those safeguards that ensure transparency and protect against a possible diversion onto the Union market of generics and biosimilars (G/Bs) in respect of which the original product is protected by an SPC;
  • supports the Commission's stance on SMEs, since they play an important role in manufacturing generics and developing biosimilars.

For more information please contact the INT Section Secretariat.