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New EU Regulation Extends Financial Penalties to Entities Beyond the Marketing Authorization Holder and Updates the Legal Framework for Medicinal Products for Human Use

By Geneviève Michaux & Luca Salernitano on January 28, 2019

Posted in European Union, Medical Devices

Regulation (EU) 2019/5, which was published a few days ago in the Official Journal of the European Union, amends the EU pharmaceutical legal framework by firstly complementing new Regulation 2019/6 on veterinary products that repeals Directive 2001/82/EC on veterinary medicinal products and incorporating the provisions on veterinary products contained in Regulation 726/2004 (in particular, Articles 30 to 45), thereby …
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European Commission Publishes Revised Guidelines on Criteria for Orphan Designations of Medicinal Products

By Geneviève Michaux, Mark Mansour & Christopher M. Mikson, MD on January 11, 2017

Posted in European Union, Patents, Pharmaceuticals

On 18 November 2016, the European Commission published a notice on the application of certain key provisions within Regulation (EC) No. 141/2000 on orphan medicinal products (the “Orphan Regulation”). Orphan medicinal products are medicinal products that are used for the diagnosis, prevention or treatment of rare diseases. An orphan designation allows a pharmaceutical company to benefit from EU incentives to develop a medicinal product, such as fee waivers for the regulatory procedures or a ten year market exclusivity.
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