Energy Sector (UK Brexit Preparedness)

As with the Financial Sector, the UK government has advised it will issue Regulations to ‘onshore’ energy legislation. This communication is here.

Unless the forthcoming changes to energy legislation relate to the Climate Change Levy or other climate related areas, this Blog post will be the only Blog post I will write about the matter.

Carriage of Dangerous Goods (UK Brexit Preparedness)

The UK government is now consulting on new 2018 CDG Regulations (applicable in Britain) that will be brought forward to amend the CDG 2009 (the 2009 dated CDG Regulations that were amended in 2011) : the document is here

(separate amending regulations will be brought forward in Northern Ireland)

(1) to remove deficiencies arising from the UK’s exit from the European Union (EU), including textual amendments to definitions and requirements that are currently predicated on the UK being a Member State of the EU. The In-force day is the day that the UK exits the EU (“exit day”).

The amendments will maintain the dangerous goods regulatory framework and the international process behind it as it is today, including the GB Competent Authority’s power to grant authorisations and implement derogations. Those involved in the carriage of dangerous goods will continue to be required to follow the requirements of RID (for rail) and ADR (for road), in the same way as before EU exit.

The amendments are purely technical. They primarily amend definitions and requirements that are currently predicated on the UK being a Member State of the EU. For example, references to the UK being a “relevant Member State” are replaced with references to “relevant territory”. Textual amendments to CDG 2009 also make it clear that references to ADR and RID will continue to be to the latest versions of those documents, whereas references to the DG Directive and the Transportable Pressure Equipment Directive (2010/35/EU) will be to the versions of those Directives in force upon exit day. These new regulations will be cited as the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment) (EU Exit) Regulations 2018.

(2) to gather input for future changes – flexibility will continue on how dangerous goods regulation is implemented in the future, the UK government is seeking input on this.

In addition, the legal requirement for vapour recovery systems to be installed on mobile tanks is reinstated.

The Petroleum (Consolidation) Regulations 2014 mistakenly revoked regulation 5 of the Carriage of Dangerous Goods by Road Regulations 1996 in its entirety. This regulation referenced, amongst other documents, the Approved Tank Requirements published by the Health and Safety Commission. These included the requirements for the design and construction of tanks in respect of the control of volatile organic compound (VOC) emissions. Whilst the references to other documents were no longer required, the reference to the Approved Tank Requirements was.

This mistake is being rectified in a separate Statutory Instrument by the Department for Business, Energy & Industrial Strategy. It is entitled [Radioactive Substances], [Transport] of Radioactive Material (Radiation Emergencies) Regulations 2018. Those Regulations will contain a reference to the Approved Tank Requirements concerning the provisions for vapour recovery systems of mobile containers carrying petrol.

Financial Sector (UK Brexit Preparedness)

Recently the UK updated its approach to ‘onshoring’ financial services and the guidance is here.

The necessary legislation (as statutory instruments) is now being drafted. There will be considerable numbers of these instruments.

Since financial services are not my area, I do not propose to Blog post further about these. So this Blog post is the only post I will write on this topic.

Financial services underpin a very wide range of ordinary daily commercial and domestic activities, such as for example the deposit guarantee scheme guarantees bank deposits. My suggestion is the reader finds someone who is tracking this subject and follow them also.

Life Science Sector (UK Brexit Preparedness)

UPDATE : further information on the Clinical Trials Regulation (issued 6th August) is here.

Today (6th August) the Department of Health & Social Care, the Medicines & Healthcare products Regulatory Agency and the Veterinary Medicines Directorate, together, issued Guidance.

The guidance is “What the implementation period means for the life science sector’. This document is here. NB – the implementation period is the UK term for the EU transition period.

The guidance states (and note, this is subject to EU-UK agreement of the Withdrawal Agreement) :

During the implementation period:

• pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, with this being recognised by the EU and vice versa

• marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets. There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP)

• firms based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures

• for medical devices, CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU. UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets.

The document also states the UK reached agreement with the EU at March European Council that the UK is to be treated as a Member State for the purposes of international agreements, including Mutual Recognition Agreements, for the duration of the implementation period. The EU will notify other parties of this approach.

This means that there will be no disruption to existing relationships underpinned by international agreements as we move into the implementation period.

A vital issue is EU legislation enacted during this implementation/transition period, or enacted beforehand with forward enforcement dates in the period, or enacted after the period – below is illustrative (from this document, and applicable to this subject)

(1) The new Clinical Trials Regulation (CTR) is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the time-limited implementation period.

If the new regulation does not come into force during the implementation period, the government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trials can plan with greater certainty.

Regardless of the outcome of the negotiations, the UK is committed to offering a competitive service for clinical trial assessment. This covers regulatory approval from MHRA as well as services from HRA, ethics services, NIHR and the NHS. (This is not applicable to the veterinary sector.)

(2) The EU Medical Devices Regulation will fully apply from May 2020. As this falls during the implementation period the government will fully implement the legislation.

(3) The new EU Regulation on in vitro diagnostic (IVD) medical devices will not apply until May 2022, which is outside of the implementation period. However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements. (This is not applicable to the veterinary sector.)

UK exits the EU (EU Barnier statement)

UPDATE : for reference, the FTA proposed by the EU bloc is set out in the EU Council Guidelines (23rd March) – here.

M. Barnier, the EU-27 negotiator, issued yesterday a useful op-ed (opinion article) on the state of play from the perspective of the EU-27 bloc. This is here.

It reminds that 80%, not 100%, of the Withdrawal Agreement is agreed to date.

Technical Notices (UK Brexit Preparedness) #1

UPDATE : the Guardian is reporting today, 5th August, that the Technical Notices (restyled as Public Service Information Notices) will be issued by the various responsible government departments (Department for Transport, DEFRA, the Home Office, and BEIS) and not DExEU as first envisaged. The Guardian article is here.

Tim Shipman, Sunday Times is reporting today, 29th July, that the Technical Notices (I posted about earlier) may not necessarily be fully public, and they will be made available not in series, but in a single bloc at the end of August 2018.

I will Blog Post again if/when there is an update.

The EU Notices are found here.

The Sunday Times article is here.