At the end of December, a new version of Chapter 1 of Volume 2A of the Notice to Applicants was published by the Commission. The Notice to Applicants is prepared by the European Commission, in consultation with the competent authorities of the Member States and the EMA, and sets out guidance on the interpretation of the EU legislation. The recent update does not introduce wholesale changes, but there are a few interesting additions:

  • A new paragraph has been added in section 5.3.1.1 in relation to the reference medicinal product clarifying that “marketing authorisations granted under exceptional circumstances in accordance with Article 14(8) of Regulation (EC) No 726/2004 or Article 22 of Directive 2001/83/EC can be used as a reference medicinal product provided that all other requirements for granting a generic marketing authorisation under Article 10 are fulfilled“. This paragraph provides some additional commentary about how this operates in practice, such as the fact the product information (i.e. the summary of product characteristics and the patient information leaflet) should note that the generic product refers to a reference medicinal product authorised under exceptional circumstances, and that particulars of that reference medicinal product are inadequate in certain specified respects.
  • A new paragraph has been added in relation to Article 10(3), whereby a product that does not fall within the definition of a generic can be authorised by cross-referring to the data for the reference medicinal product, but the results of appropriate pre-clinical tests or clinical trials must be provided to establish the safety and efficacy of the product, despite the differences from the reference product. The new paragraph states that the extent of the additional studies and bridging data required will be a matter of scientific assessment by the relevant competent authority. This reflects recent case law from across the EU.
  • The section on biosimilar products contains new wording to clarify that an Applicant may be able to compare a biosimilar with a non-EEA comparator where the comparator is authorised by a regulatory authority with similar scientific and regulatory standards as EMA or EEA competent authorities. This may assist companies post-Brexit who want to conduct comparison studies with a UK-authorised product.

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