101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 138 After 29 March 2019 if there’s no deal Medicines If there’s no deal, the UK’s participation in the European regulatory network would cease. The MHRA would take on the functions currently undertaken by the EU for medicines on the UK market. This would require changes to UK law, via the Human Medicines Regulations 2012 (HMRs). The MHRA is planning a public consultation in early autumn on some of the key proposed legislative changes. Detailed information on manufacturer batch testing and certification can be found in the separate technical notice on this subject. Medical Devices The UK will recognise medical devices approved for the EU market and CE-marked. Should this change in future adequate time will be provided for businesses to implement any changed new requirements. The UK will comply with all key elements of the Medical Devices Regulation (MDR) and the in vitro diagnostic Regulations (IVDR), which will apply in the EU from May 2020 and 2022 respectively. Formal UK presence at EU committees in respect of devices will cease. Clinical Trials The 2004 Regulations will remain in force, modified using powers under the EU (Withdrawal) Act (EUWA) to make sure they still work in the UK after exit. The new EU Clinical Trials Regulation (CTR) 536/2014 will not be in force in the EU at the time that the UK exits the EU and so will not be incorporated into UK law on Exit day under the terms of EUWA. However, we’ll align where possible with the CTR without delay when it does come into force in the EU, subject to usual parliamentary approvals. This alignment will happen after 29 March 2019 so it’s not addressed in this guidance. Implications The EU (Withdrawal) Act will ensure that existing EU rules are converted into UK law at the moment of exit, with changes where necessary to make sure the rules work in the UK. Where this is needed, we’ll give adequate time for business to implement any new requirements. Additionally, where possible, we’ll be making use of the information we already have to complete administrative tasks for continuity of work and licences. There are a number of changes where a UK approach will be required. Some of these are set out below. Other areas and further detail on some of the areas included here will be covered by consultation in the early autumn. Medicines Converting centrally authorised products to UK Marketing Authorisations Most medicines on the UK market already have a UK Marketing Authorisation (MA), and this will be unaffected by our exit from the EU. However, most new medicines come to market via a licencing route overseen by the EMA. These are collectively known as Centrally Authorised Products (CAPs). To ensure such medicines will continue to be authorised for use in the UK, all CAP MAs will automatically be converted into UK MAs on 29 March 2019. MHRA will write to all CAP Marketing Authorisation Holders (MAHs) prior to 29 March 2019 to inform them of the conversion process (known as “grandfathering”) and to provide them with the opportunity to opt out of receiving a UK MA. MAHs will have a period of time from exit day to provide MHRA with baseline data for CAPs that are converted into UK MAs. The exact requirements will be communicated at a later date as this is subject to consultation. Initial Marketing Authorisation applications After EU Exit, to market a product in the UK, an initial MA application will need to be submitted to the MHRA and will go through a national assessment. MHRA will take a streamlined approach to approving UKMA applications that places no greater burden on industry and ensures that patients can access new and innovative medicines at the same time as EU patients. The UK will no longer be a part of the EU centralised, mutual recognition and decentralised procedures. Medicines licensed via Mutual Recognition and Decentralised Procedures The mutual recognition and decentralised procedures (MR/DC) are two EU routes to obtaining a MA to market a medicine within multiple EU and EEA countries. Existing medicines that received a MA for the UK via the MR or DC routes prior to 29 March 2019 will be unaffected as they already hold a national UK MA. In-progress licensing procedures at time of exit If there’s ‘no deal’, the outcome of EU procedures (including mutual recognition, decentralised and centralised procedures) that have not reached the decision phase at the time that the UK exits the EU, will not be valid in the UK. However, the MHRA will take EU decisions into account where possible. For centralised procedures in progress at time of EU exit:  The application, as submitted to the EMA, will need to be submitted to the MHRA