With much fanfare, in January 2023, the European Commission released its proposal to extend the MDR transition periods and abolish the ‘sell-off’ deadline, after which medical devices and in vitro diagnostics (IVDs) would have to be withdrawn from the EU and EEA market. Today, the proposal has been adopted via Regulation 2023/607 (the Regulation), and will come into force today, 20 March 2023. This date is now important, as CE certificates that expired before today may be able to be considered as valid if certain conditions are met. Certificates that expire from today until the new transition periods will be considered as valid if the conditions set out below are met. This provides important breathing space for companies and should ensure that a large number of devices are not withdrawn from the market over the next year.Continue Reading Extension to EU MDR transition periods finalised
On 27 February 2023, an agreement in principle was reached by the UK and EU, known as the Windsor Agreement, relating to post-Brexit trade issues in Northern Ireland (NI). The principles are expected to be approved shortly by the EU-UK Joint Committee. The UK Government and the EU institutions will then enact legislative measures to make the necessary amendments to their laws.
Following Brexit, from 31 January 2020, the UK is no longer subject to EU single-market rules or the EU legislative framework. However, under the EU-UK Withdrawal Agreement’s Protocol on Ireland and Northern Ireland, NI continues to follow EU rules. This is to avoid customs checks between NI and the Republic of Ireland. In practice, this means that medicinal products on the market in NI must be authorised in line with the EU regime, which no longer applies in Great Britain. This causes difficulties for companies marketing their products in the UK, as different authorisations, following different rules, apply in different parts of the UK. It also means that patients have access to different products in GB or NI.
The current agreement covers a number of sectors, and in relation to medicines, the aim is to simplify supply between GB and NI, and ensure that only one authorisation is needed and one set of rules needs to be followed within the UK. However, much detail still needs to be published so that companies can fully understand the impact of the changes on their medicines supply chains.Continue Reading The Windsor Agreement and supply of medicinal products in Northern Ireland
On 22 September 2022, the UK government introduced the Retained EU Law (Revocation and Reform) Bill 2022 (the ‘Bill’) to Parliament. The Bill provides a mechanism to remove EU law currently on the national statute book and transition towards only domestically enacted legislation. A revised Bill was published on 29 November 2022 following its first debate in parliament and scrutiny by the Public Bar Committee. If current timelines are maintained, it is anticipated that the Bill would be passed in April or May 2023.
Continue Reading The Retained EU Law (Revocation and Reform) Bill 2022 – key facts and issues
As of today, the 26 May 2022, the in vitro diagnostic Medical Devices Regulation (EU 2017/746) (IVDR) applies across the EU.
Those working in the industry will be aware that the implementation of the IVDR has been far from straightforward, and that there is still a lot of work to be done. In this post, we provide an overview of the current status of the transitional provisions, identify recently published guidance, and briefly consider the position in the UK and Switzerland.Continue Reading The EU IVDR is here!
As we have previously reported, under the Northern Ireland Protocol of the Withdrawal Agreement between the EU and UK, Northern Ireland (“NI”) has continued to follow the EU rules after the end of the transitional period. In contrast, Great Britain (“GB”) now has a freestanding independent regulatory regime. This means that there are two sets of rules that apply in the UK, and this has led to difficulties with medicines, and other products, moving from GB to NI (the route by which the majority of products reach the market in NI).
In December 2020, the European Commission published a notice that allowed certain flexibilities to be in place through 2021 to ensure there were no medicine shortages in NI (as well as other territories historically dependent on medicines supply through GB). As 2021 concluded, industry – and patients – had been concerned that no long-term solution had been found.
After protracted negotiations, on 17 December 2021, the European Commission put forward proposals to ensure the continued undisrupted supply of medicines from GB to NI. The proposals seek to ensure that patients in NI will have access to life-saving medicines at the same time as patients in the rest of the UK. These proposals also allow time to put in place long-term solutions for the supply of products to NI, and time for industry to adapt to future regulatory requirements and changes.
In parallel, legislation changes have been made in the UK, and the MHRA guidance has been, and is being, updated to reflect the proposals, although they are not yet formally adopted by the EU legislative bodies. Further, the MHRA has stated that there is a reporting obligation on industry to notify the MHRA if the flexibilities applicable to NI will not be used.Continue Reading Brexit update: Supply of Medicines from Great Britain to Northern Ireland
The long awaited EU Clinical Trials Regulation applies from today, 31 January 2022.
Continue Reading EU Clinical Trials Regulation: Today is the Day!
On 24 December 2020, the European Union and the United Kingdom reached an agreement in principle on the EU-UK Trade and Cooperation Agreement (the Agreement). This was the result of many months of detailed negotiation within an increasingly difficult political environment. The final Agreement does not cover all of the aspects about which life sciences companies have been concerned, and there are areas that will likely be the subject of further discussion during the implementation of the Agreement. However, many view the Agreement as being an important first step in the UK’s continuing relationship with the EU. We set out below a summary of the key aspects of the Agreement relevant to life sciences companies.
Continue Reading The EU-UK Agreement and the implications for life sciences companies
As the end of the transition period draws near and new laws and regulations are set to come into effect at 11.00pm UK time on Implementation Period Completion Day (31 December 2020), it is important to appreciate the impact of the changes to businesses navigate through a post-Brexit era. Once the UK is no longer part of the European single market, what will it mean for parallel trade and exhaustion of intellectual property (IP) rights when goods are exported out of the UK into the EU and vice versa.
Continue Reading End of Brexit transition period: Exhaustion of Intellectual Property Rights and Parallel Trade in the UK and EU
On 20 October 2020, “The Human Medicines (Amendment etc) (EU Exit) Regulations 2020” Bill was laid before the UK Parliament (the 2020 Bill). The Bill proposes amendments to various Statutory Instruments that were drafted in 2019 (the 2019 SIs) in anticipation of a “no-deal” Brexit. The 2019 SIs sought to enable the pharmaceutical regime in the UK to function independently of the EU, and for the MHRA to act as a stand-alone regulator of medicinal products placed on the UK market. The 2019 SIs have now been revived so that they are effective beyond the end of the transition period, which expires on 31 December 2020, subject to any agreement that may be reached with the EU about the ongoing relationship between the UK and EU.
The 2020 Bill includes a number of changes to the 2019 SIs, which themselves changed the current Human Medicines Regulations of 2012. However, one area that is of particular interest to the industry is the regulatory data protection (RDP), marketing protection and orphan exclusivity periods that apply to medicinal products authorised in the UK after the transition period. The 2020 Bill changes the position that had previously been set out in the 2019 SIs.
Continue Reading RDP periods in the UK after Brexit
On 11 June 2020, the European Medicines Agency (EMA), during its Management Board meeting, has endorsed the methodology and next steps leading to the go-live of the Clinical Trials Information System (CTIS) which is now fixed for December 2021. A group consisting of representatives of the EU Member States and the European Commission has been set up to prioritise and coordinate all outstanding issues prior to go-live. The CTIS is the centralised EU portal and database for information storage foreseen by the Clinical Trials Regulation.
Continue Reading EU Clinical Trials Regulation: The Clinical Trials Information System expected to go live by December 2021, according to the EMA