Synapse - February 2019

This month on Synapse

SPC manufacturing waiver for export (and stockpiling)

Matthew Royle and Paul England explain the status and content of the draft SPC manufacturing for export waiver currently in the EU legislative process, including the controversial issue of the stockpiling period proposed by the EU Parliament.

Falsified Medicine Directive continued: Safety features on medicinal products and its consequences

Judith Krens and Irenah Klink explore the Delegated Regulation 2016/161, which has come into force as part of the implementation measures by the Commission in the context of the Falsified Medicine Directive (2011/62/EU).

The NHS long-term plan – The focus on technology and data

Ashley Stansfield discusses the NHS "Long Term Plan", and the implications and opportunities for businesses arising from its technology and data ambitions.

SPC for ezetimibe/simvastatin considered invalid in preliminary relief proceedings

Judith Krens and Misja Boeken discuss the Court of Appeal of the Hague case dismissing a request for a preliminary injunction based on the Dutch SPC on ezetimibe and simvastatin.