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

As COVID-19 infiltrates every aspect of our daily lives and the world races to respond and to address the pandemic, there is a consistent theme which offers all of us hope. Collaboration. To combat the outbreak, we have seen the emergence of large numbers of companies joining to pool their resources and to cross-share their valuable know-how. Read more

On Saturday (4 April 2020) the UK Government issued a press release on how the medicines and medical devices regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), is investigating the increasing number of bogus medical products being sold through unauthorised websites claiming to treat or prevent COVID-19 cases of fake or unlicensed COVID-19 medical … Read more

New regulations have been published in Spain to address the health crisis caused by the COVID-19 outbreak. We will analyse below the most significant impacts that the new measures will have, essentially included in Royal Decree-law 11/2020, of 31 March, which adopts additional urgent social and economic measures to tackle COVID-19 (“RDL 11/2020”), as well … Read more