Cooley (UK) LLP

This Practice Note explains the concept of regulatory data protection (RDP), also known as ‘data exclusivity’, provides guidance on how RDP works in practice and the impact it has on the entry into the EU market of generic and biosimilar medicinal products.

This Practice Note explores the changes introduced to the regulation of medicinal products in the EU by the Falsified Medicines Directive to combat the increase in the incidence of falsified medicinal products. First, the Practice Note considers what is meant by the term ‘falsified medicinal product’, before looking at the measures introduced by the Falsified Medicines Directive: greater control of active substances, obligations for actors in the supply chain, the introduction of safety features on the packaging of medicinal products and the common logo for websites selling medicinal products. This Practice Note also provides an overview of the UK regime for falsified medicines.

This Practice Note considers inspections of records in the context of reinsurance. It considers the scope of a reinsurer's rights of inspection and the purposes for which inspections are undertaken. It also considers questions of privilege and risks, such as waiving defences by exercising contractual inspection rights. This Practice Note also provides practical guidance in relation to inspections, from the perspectives of both cedant and reinsurer.

This Practice Note explains the concept of regulatory data protection (RDP), also known as ‘data exclusivity’, provides guidance on how RDP works in practice and the impact it has on the entry into the market of generic and biosimilar medicinal products.