BREXIT
regulations for clinical trials, which will further integrate clinical trial processes and requirements.
If the UK leaves the EU with no deal
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.
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, the government plans to align, where possible, with the CTR without delay when it does come into force in the EU, subject to usual parliamentary approvals.
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, the government will give “adequate time” for business to implement any new requirements. Additionally, where possible, the government will be making use of the information it already has to complete administrative tasks for continuity of work
and licences.
Converting centrally authorised products to UK Marketing Authorisations
There are a number of changes where a UK approach will be required, such as medicines.
Most medicines on the UK market already have a UK Marketing Authorisation (MA), and this will be unaffected by an 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. MHRA will write to all CAP Marketing Authorisation Holders (MAHs) prior to 31 October 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 Brexit, to market a product in the UK, an initial MA application will need to be submitted to the MHRA and will go through
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.
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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 31 October 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: l The application, as submitted to the EMA, will need to be submitted to the MHRA
l If the Committee for Medicinal Products for Human Use (CHMP) has issued an opinion by exit day, MHRA will make its decision taking into account the CHMP opinion
l If not yet at the opinion phase, the MHRA will continue to assess the application as a national procedure. MHRA will take into account any CHMP assessment that had already taken place.
For MR or DC procedures in progress at time of Brexit it’s proposed that a transitional provision will be made for MRP and DCP
SEPTEMBER 2019
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