It is fair to say that Britain’s exit from the European Union is long overdue, with Brexit now extended until January 31st. This ‘flextension’ period has been accepted by the UK with hopes of holding a general election before the end of the year, but the possibility of a ‘no deal’ Brexit still remains.
What does all this Brexit jargon mean for your business? If the UK finally goes ahead with Brexit this would mean that harmonised European legislation will no longer apply and businesses already established in the EU may have to meet extra requirements for marketing in the UK. So, while the UK attempts to undo 46 years of economic integration in one stroke, businesses should take advantage of this extension period by ensuring they are prepared for what’s to come.
Here at RNI Consulting, our team of scientific and regulatory consultants provide businesses with the most up to date expertise regarding nutritional, medical, cosmetic and borderline products. With offices in the UK, Europe and the US, RNI is perfectly positioned to give you the support you need to get your business Brexit ready.
Here is what we know so far:
Following Brexit, the UK seeks to mirror European systems as far as practically possible. If the UK leaves without a deal, EU Regulations relating to nutrition will be transposed into UK law. The UK government will then make the necessary changes to retain EU law through the Nutrition (Amendment) (EU Exit) Regulation 2019 – with the main change being the transfer of responsibility from one single European Commission (EC) to 4 administrations (in England, Ireland, Scotland & Wales). These administrations will each legislate independently, which could mean that businesses wanting to sell in the UK may have to meet extra requirements specific to each administration. With that being said, the UK’s Secretary of State will also have power to legislate for the whole of the UK, meaning that requirements may be harmonized across the 4 UK administrations.
Regarding the addition of vitamins, minerals and other substances to food, the UK have established a new register which has retained information from the EU. Following Brexit, each UK administration may then amend the criteria in this register if they wish. Similarly, with regards to health claims, the UK will have its’ own list of authorized and rejected health claims, where claims already authorized by the European Food Safety Authority (EFSA) will be retained in the UK register. However, applications for new claims will have to be made at GOV.UK where the UK has established a new committee which will conduct scientific evaluation of these. This means that two separate applications for health claims will be required for both the EU and UK. It is also worth noting that claim applications which are still pending in the EU on exit day will require a new application for assessment in the UK.
In the EU, food groups such as ‘Foods for Special Medical Purposes’ and ‘Foods for Specific Groups’ were previously governed under PARNUTs legislation (2009). This legislation was repealed by new regulations in 2013, which made changes to the old legislation. Food groups previously governed under PARNUTs were given a ‘transition period’- offering them time to make the necessary changes to comply with the new regulation. On exit day, specific rules set out in the new regulation, that do not yet apply due to the transition period, will not be part of UK legislation.
The unfortunate timing of the European Medical Device Regulation transition only further compounds the confusion over ensuring conformity of medical devices in the European and UK markets.
Most importantly, a new Medical Devices (Amendment etc.) (EU exit) Regulations 2019 (UK MDR 2019) is planned to come into force Brexit day. This new UK MDR 2019 will mirror (as far as practicable) the European Medical Device Regulations (MDR 2017). In the event of a No-Deal Brexit (and without any specific arrangements), the UK will not continue to participate in the shared EU regulatory framework. The key takeaways from this are: the role of Notified Bodies, the MHRA, Conformity Assessments and Parallel Importing.
UK based Notified Bodies will no longer be able to assess conformity of medical devices for the EU. Furthermore, CE marks issued by a UK based Notified Body may not be recognized by the EU post Brexit (unless designated by a European Competent Authority). The MHRA will continue to perform post-marketing surveillance for the UK market but will no longer receive safety data that is currently shared across all member states of the EU.
All medical devices would need to be registered with MHRA prior to being placed on the UK market. This also means that a new “UK Responsible Person” role with a UK registered address is required to ensure product registration. There are plans to allow a grace period to minimise disruption to the supply of medical devices. There is also a proposal for a ‘UKCA’ mark which would be issued by the MHRA as an equivalent CE mark.
There remain 2 possible outcomes for the regulation of medical devices following Brexit: (1) The UK stays within the EU regulatory system and (2) the MHRA becomes the sovereign regulator in the UK. Both options have merits such as mirroring the status quo or enabling a Mutual Recognition Agreement.
Overall, the disruption caused by Brexit is centred around general administration due to the nature of the industry being ‘self-regulated’. The likely outcome is an adaptation of the European Cosmetic Regulation EC 1223/2009 to a new UK Cosmetic Regulation. This new Regulation would mirror the EU regulation closely including the definition of ‘community’ in relation to the Responsible Person and their obligations. Reference to ‘community’ will therefore stipulate 2 geographical regions.
Most importantly, it is assumed that 2 Responsible Persons will be required going forward. The UK Responsible Person will be in control of the Product Information File, registration and post marketing actions for the UK region only whereas the EU Responsible Person will handle similar tasks in the EU region as currently. The flow on effect of having 2 Responsible Persons requires independent Product Information Files, 2 product notifications in the Cosmetic Product Notification Portal (CPNP) and possible labelling changes.
Overall, the potentially significant healthcare and economic ramifications that a disruption could entail, it is positive that in fact there is UK industry support for continued collaboration with the EU in terms of incorporating existing Directives and Regulations. However, until a final Brexit outcome is announced, we can only speculate and predict the extent of this relationship.
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