Last week’s round-up, 16-20 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   Brexit-related guidance for companies 20 March 2020 The EMA’s Brexit-related guidance for companies has been updated, with the publication of updated ‘EMA notice to stakeholders’ and ‘EMA practical guidance’. The two documents explain the intricate preparations companies need to make to prepare for the end of […]

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Last week’s round-up, 30 September – 04 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Delays in treatment of requests for revision and renewal of CEPs 03 Oct 2019 The EDQM has communicated that it is currently experiencing some difficulty in achieving the assessment times for revisions and renewals of CEP applications. The delay is currently about 5 weeks and the EDQM has […]

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Real Generics’ Regulatory News Digest For Generics – 24 November 2015

Planned changes to intellectual property protection in Europe Towards the end of October 2015, the European Commission published a working document entitled A Single Market Strategy for Europe – Analysis and Evidence. The document suggests a number of changes in intellectual property protection that would have a positive and significant impact on manufacturers of existing […]

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