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

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. Continue Reading European Commission Publishes Revised Guidelines on Criteria for Orphan Designations of Medicinal Products