Header graphic for print
Focus on Regulation

Tag Archives: Brexit

Updated EMA guidance on centrally authorised medicines raises new considerations for Brexit preparations

On 19 June 2018, the European Medicines Agency (EMA) published updates to its Brexit Q&A document for human and veterinary medicines authorised via the centralised procedure and to its practical procedural guidance on making Brexit related changes to the authorisations for those products. The updated version (“Rev 03”) of the EMA Q&A document includes new

Implications of European Commission’s proposal for a Regulation to modify existing EU rules to allow manufacturers to apply for new approvals in 27 EU Member States to replace their UK type-approvals following Brexit

On 4 June 2018, the European Commission adopted a proposal for a Regulation to modify existing EU rules to allow manufacturers of vehicles to obtain new approvals from the 27 EU Member States who will remain post-Brexit to replace their existing UK-type approvals. Although the proposed Regulation focuses specifically on vehicles it could be interpreted

UK Government Responds to Brexit Life Sciences Regulatory Recommendations

The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit: medicines, medical devices and substance of human origin”, which considered the regulatory arrangements needed for the safe and effective supply of medicines and medical devices post-Brexit (see our blog

UK Parliamentary Report Published on the Impact of Brexit on the Pharmaceutical Sector

The Business, Energy and Industrial Strategy Committee, a parliamentary select committee, has published a report on the consequences of Brexit on the UK pharmaceutical industry. The report examines the impact of different outcomes of the UK/EU negotiations, including a “no deal” scenario, on tariff barriers, non-tariff barriers (e.g. border delays), regulatory alignment, trade opportunities, skilled

Rules of Origin: a ‘hidden hard Brexit’ for the UK food industry?

The Food and Drink Federation (“FDF“) has published a report on the potential impact of rules of origin on UK food and drink exporters in the likely event that the UK ceases to be part of the EU customs union after Brexit. Rules of origin are the detailed content requirements that determine whether goods are

Brexit – what’s next for medical devices?

On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products, including medical devices and in vitro medical diagnostic medical devices. The notice presents the steps that manufacturers of medical devices and

House of Lords Committee critical of “unacceptably wide” powers in the Withdrawal Bill

The House of Lords Delegated Powers and Regulatory Reform Committee has published a report on the European Union (Withdrawal) Bill which sets out its concerns on the “unfettered discretion” and “excessively wide legislative powers” given to Ministers by the Bill. The report is particularly critical of the so-called Henry VIII powers granted to Government by

EMA prepares plan to face Brexit

European Medicines Agency (EMA) has released a business continuity plan dealing with the potential implications of Brexit. EMA, which is currently established in London, will be required to transfer the Agency’s headquarters to another EU Member State. With the aim to conserve Agency’s capacities to protect public and animal health, EMA has issued a press

Why the Repeal Bill is central to making Brexit a success

Leaving the EU will require the most comprehensive re-writing of the UK’s statute book ever undertaken. Parliament must unpick over 40 years of integration between the UK and the EU legal systems and ensure no gaps are left in the process.  The Government’s solution, the highly anticipated, formerly ‘Great’, Repeal Bill, is due to be published

General Election 2017: Comply with the Campaigning Rules

The 2017 General Election campaign is up and running.  There are strict rules on campaign spending by non-political parties during the 365 days leading up to a General Election, which apply retrospectively back to 9 June 2016 until 8 June 2017.  With businesses engaging with the British public about important political issues like never before,

Finger on the polls – May calls for snap General Election

UK Prime Minister Theresa May has today announced that she intends to trigger a General Election to take place on 8 June 2017. The announcement is the latest unexpected twist in an unpredictable 12 months in British politics.  What does this surprise development mean for the Brexit process?  Read the full blog here.

What you need to know before Brexit gets underway this week

The Brexit process gets officially underway this week when the UK formally notifies the European Council of its intention to withdraw from the EU on 29 March 2017.  The road ahead is untested and uncertain, as the UK will be the first EU Member State ever to leave the Union. Hogan Lovells will be hosting

UK to Seek Close Relationship with EMA Post-Brexit

UK Secretary of State for Health, Jeremy Hunt, has stated in a Health Select Committee meeting that he does not expect the UK to remain part of the European Medicines Agency (“EMA”) or the EU medicines regulatory framework post-Brexit, but that the UK should seek a very close working relationship with the EMA and the