<p>As part of the preparations for a ‘no deal’ exit from the European Union, the Department developed proposals for and informally consulted with the relevant stakeholder representative bodies on a power to modify the application of the Human Medicines Regulation 2012 to deal with serious shortages in the event of a ‘no deal’ exit. This power can only be used in the case of a ‘no deal’ exit from the EU, only have effect until two years after exit day and only apply in the case of a serious shortage where one but not the only significant factor contributing to the shortage is the withdrawal of the United Kingdom from the EU.</p><p>The legal provisions will clarify that a serious shortage is a serious shortage in the opinion of Ministers.</p>