Earlier this month, the European Commission and representatives of the EU Member States discussed potential revisions to the European Commission’s Note on handling of duplicate marketing authorisation applications (the 2011 Note). According to the information published by the Commission, the discussion took place on 7 November 2019 during the latest Pharmaceutical Committee meeting. The discussion was intended to be focussed on duplicate marketing authorisations for biological medicinal products and the outcome of the related public consultation that took place in 2018.

Background

As we set out in our previous blog, the 2011 Note provides guidance on how the European Commission handles requests for duplicate marketing authorisations submitted through the centralised marketing authorisation procedure in accordance with Article 82.1 of Regulation (EC) No 726/2004 which was motivated by concerns that several MA’s granted for the same product could lead to partitioning of the market. As a general principle, the Regulation contemplates the existence of duplicate marketing authorisations only in two situations; first, where co-marketing with an independent company is envisaged and secondly “where there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients”. In this latter case the Commission has required the applicant to demonstrate that the grant of a duplicate marketing authorisation will result in improved availability of the medicinal product in the EU. The 2011 Note states that, in principle, the grant on “public health” grounds of a duplicate marketing authorisation for a “first generic” granted to an originator (known as an “authorised generic” in the USA) is possible because of its potentially positive impact on the availability of the medicinal product.


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The European Commission has published a consultation on proposed changes to its 2011 Note on the handling of duplicate marketing authorisations. The Consultation Document explains that the objective of the consultation is to seek views on the impact of duplicate authorisations of biological medicinal products on the availability of biosimilars to healthcare professionals and patients.

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