Extended scope EU Penalties Regulation enters into force

As of 2 July 2012, infringements of the EU’s paediatric and new pharmacovigilance rules fall within the scope of the revised EU Penalties Regulation and are now subject to financial penalties of up to 5 percent of the marketing authorization holder’s annual EU turnover.

The EU Penalties Regulation (658/2007) has been in force since 2007 and enables the European Commission to impose financial penalties on marketing authorization holders for infringements of obligations related to marketing authorizations for centrally authorized medicinal products.

Commission Regulation (488/2012) of 8 June 2012 expands the scope of the EU Penalties Regulation to infringements of the EU’s new pharmacoviligance rules as well as the EU’s rules applicable to medicinal products for paediatric use. The European Commission can now impose significant financial penalties in case of an infringement by a marketing authorization holder of the obligation to, inter alia:

• operate a comprehensive pharmacovigilance system, including the operation of a quality system, maintenance of the pharmacovigilance master file and performance of regular audits;
• operate a risk management system;
• keep product information up-to-date with current scientific knowledge, and ensure that public announcements relating to information on pharmacovigilance concerns are presented objectively, are not misleading, and are notified to the European Medicines Agency;
• conduct post-marketing studies and submit them for review; or to
• comply with the timelines for initiating and completing deferred paediatric studies, and submit an annual report to the European Medicines Agency on progress with such deferred studies.

Marketing authorization holders are advised to carefully review the amended scope of the EU Penalties Regulation, as well as the relevant obligations set out in the EU Medicinal Products Regulation (726/2004) and the EU Paediatrics Regulation (1901/2006), and to ensure their continuing compliance with these obligations. Please contact one of the Sidley lawyers listed below, or your usual Sidley contact, with any questions.