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Key points: In Australia responding to the urgent need for COVID-related medical devices the TGA implemented a number of emergency measures to bring medical devices to market faster. The emergency regulatory measures have proven agile, flexible and successful with the potential risks to the public well managed. The regulatory measures have potential utility beyond the … Read more
The European Commission has this week published a wide-ranging and ambitious Pharmaceutical Strategy for Europe, and an Action Plan on Intellectual Property. Pharmaceutical Strategy for Europe The new pharmaceutical strategy for Europe is a key pillar of the European Health Union, which President von der Leyen called for in her 2020 State of the Union … Read more
When the world finally emerges from the public health crisis that is COVID-19, we will all be reminded that the crisis presented by climate change remains, and looms larger than ever. Read more
In this article we review the impact of the COVID-19 pandemic on the procedure of, and approach taken by the judiciary in, the patent courts of England & Wales, Germany, France, Italy, and at the EPO. Read more
Two important pieces of medicines and medical devices regulation are currently pending in the UK and the European Union: in the UK, the Medicines and Medical Devices Bill (the UK Bill), and in the EU, the Medical Devices Regulation (the EU Regulation on Medical Devices). COVID-19 has also had an impact, with the EU Regulation … Read more
Herbert Smith Freehills has published a new global guide on supply chain difficulties arising from the COVID-19 pandemic and associated restrictions and solutions. Supply chain difficulties are at the heart of the pressures facing businesses during the COVID-19 pandemic. In our latest guide we look at supply chain pressure points and what is being and … Read more
The UK Government has issued an indemnity in relation to claims brought against the manufacturers of new ventilators produced to deal with the COVID-19 pandemic in the UK as part of the Government’s campaign for rapidly manufactured ventilator systems (RMVS). A letter from Michael Gove MP to the Chair of the Public Accounts Committee (3 April) confirms … Read more
The global COVID-19 pandemic has, to an extent, re-directed some of the actions and focus of competition authorities, which are placing increasing scrutiny on several strategic industries to ensure they do not profit from the crisis. Some of these developments, as outlined below, are relevant to the pharmaceutical industry (for information on COVID-19’s more general … Read more
The Order establishes a number of special measures for medical devices listed in the annex to the Order, surgical facemasks and surgical gowns: Permit. A prior operating permit for facilities (as established in article 9 of Royal Decree 1591/2009, of 16 October, which regulates medical devices) will still be required to manufacture medical devices necessary … Read more
