Pharma & regulatory

The marketing of medicines is subject to strict regulations based on European Directives implemented in Dutch legislation and European Regulations directly effective in the Netherlands. Based on this legislation, the Medicines Evaluation Board (in the Netherlands: CBG) grants national marketing authorizations for medicinal products, whereas the European Medicines Agency (EMA) grants marketing authorisations valid throughout Europe.

The regulatory team of BarentsKrans has years of experience with national and European issues concerning medicinal products. The team frequently advises on a variety of topics related to market access for medicinal products and to obtaining marketing authorisations via a national procedure, a decentralized procedure (DCP), a central procedure (CP) or a mutual recognition procedure (MRP). This includes advice on whether an active substance of a medicinal product can be identified as a new active substance (NAS status), whether a product (still) enjoys data and/or market exclusivity and when a marketing authorisation belongs to the so-called global marketing authorisation (e.g. in the context of an application for a generic product, based on article 10 of Directive 2001/83/EC). Our regulatory team is also consulted about issues regarding the naming of medicinal products. If necessary, we liaise with CBG and EMA. In case our clients experience problems with diverging opinions of Concerned Member States in a DCP, MRP or otherwise, we represent them before the CMDh and CHMP.

The team assists clients when their marketing authorisations for medicinal products are challenged. We regularly represent clients in administrative proceedings before the Dutch administrative courts, up to the Council of State.

Clients from all over the world consult our team with questions about the validity and grant of supplementary protection certificates (SPCs) and paediatric extensions (PEs). As a result of the unique combination of our in depth knowledge of the regulatory system concerning medicinal products and our extensive litigation experience regarding pharmaceutical patents, the regulatory team can fully present both regulatory and patent-related arguments to the Court and can therefore operate at the cutting edge of the SPC-legislation.

 

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