Medicines (UK and EU Brexit Preparedness)

UPDATE : the UK is consulting on making the MHRA standalone in the event of No Deal. The consultation is here. The MHRA is the UK Medicines and Healthcare Regulatory Agency.

Companies are reminded to plan for the UK’s withdrawal from the EU on 29 March 2019 and are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU. In particular, EMA encourages companies to refer to the updated questions and answers and practical guidance for industry published on 19 June 2018.

While the evaluation of the risk of supply and shortages of centrally authorised medicines is on-going, all marketing authorisation holders are reminded to inform the Agency of any change of plans which may affect medicine supply to patients in Europe.

In addition, applicants submitting new marketing authorisation applications to EMA are reminded to ensure that the arrangements they are proposing in their application remain valid after Brexit and likewise make the necessary changes by 29 March 2019.

Companies are also reminded that, if they foresee a product supply issue with a medicine, they have a legal obligation to inform EMA.

The text in italics is part of the European Medicines Agency (EMA) press release issued today that informs that companies are stepping up and that the focus is now on 39 centrally authorised Medicines down from 108. The Press Release is here.

Marketing authorisation holders for over half of the 108 medicines have either taken steps to transfer their marketing authorisation to an EU27 country, change their qualified person for pharmacovigilance (QPPV), relocate their pharmacovigilance system master file (PSMF), adapt their logistics, supply chains and contracts, or relocate some manufacturing sites. According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the European Economic Area (EEA) in order for a company to be able to market a medicine in the EU.

More Technical Notices (UK Brexit Preparedness)

The UK has today (24th September 2018) published more Technical Notices, some have a slightly earlier date. The collection to date is here.

Please note in particular the new Notices issued in the topics of Importing and Exporting, and Product Labelling.

Please note there is now a Technical Notice on REACH. This only covers the registration side. Given its tone, I would envisage in the first instance Safety Data Sheets and Marketing and Use Restrictions might not alter much, if at all. I will Blog post again if there is further information issued or made available on this.

(1) The Health and Safety Executive (HSE) would act as the lead UK regulatory authority, from the day the UK leaves the EU, building on its existing capacity and capability.

(2) The new regulatory framework would: enable the registration of new chemicals through a UK IT system that is similar to the existing EU IT system; provide specialist capacity to evaluate the impact of chemicals on health and the environment; ensure sufficient regulatory and enforcement capacity in the HSE, the Environment Agency (EA) and other regulators, enabling them to recommend controls in response to the hazards and risks of substances; and provide for an appropriate policy function in Department for Environment, Food & Rural Affairs (Defra) and the devolved administrations.

(3) In a ‘no deal’ scenario the UK would not be legally committed to medium- or long-term regulatory alignment with the EEA.

Please note there is now a Technical Notice on the CTA between the UK and Ireland.

(1) If you are an Irish citizen you would continue to have the right to enter and remain in the UK, as now. You are not required to do anything to protect your status.

(2) In addition, you would continue to enjoy the reciprocal rights associated with the CTA in the same way that British citizens in Ireland would if there is no deal. These rights include the right to work, study and vote, access to social welfare benefits and health services. Where required domestic legislation and agreements would be updated to ensure that the CTA rights continue to have a clear legal basis.

(3) There would be no practical changes to the UK’s approach to immigration on journeys within the CTA: as now there would be no routine immigration controls on journeys from within the CTA to the UK. The legislation governing this approach will remain unchanged when the UK leaves the EU. So too will the legislative framework of integrated immigration laws between the UK and the Crown Dependencies. The CTA arrangements would be maintained, promoting the benefits of migration between these islands.

Please note the consultations proposed re GMOs.

Please email me if you need to discuss any matter.

More Technical Notices (UK Brexit Preparedness)

The UK has today issued further Brexit Preparedness Notices. The existing online location is updated – here.

Please note particularly :

(1) CE marking – in the “Labelling products and making them safe” group

(2) Driving

(3) BAT standards – in the “Protecting the environment” group

(4) F-gases and ODS – in the “Protecting the environment” group

(5) The three Notices in the “Travelling between the UK and the EU” group

(6) Oil and gas activities – in the “Regulating energy” group

(7) European Works Councils in the “Workplace rights” group (already issued)

Any questions, please email me.

Agriculture Bill 2017-19 (UK)

UPDATE : initial reaction from Scottish Ministers – here.

The Brexit bill – the Agriculture Bill 2017-19 was published today, its second reading is tomorrow. The document is here.

The Agriculture Bill (“the Bill”) will provide the legal framework for the United Kingdom (UK) to leave the Common Agricultural Policy (CAP) and establish a new system based on public money for public goods for the next generation of farmers and land managers. It is the first Agriculture Bill to be published in 70 years.

The Agriculture Bill includes the following:

(1) Powers to give financial assistance and move towards a new system based on paying public money for public goods. Such payments may encompass (but are not limited to) environmental protection, public access to the countryside and measures to reduce flooding.

(2) Powers to collect and share data from those within or closely connected to the agri- food supply chain. The data collected and shared under these provisions will help farmers and producers increase productivity, help producers to manage risk and market volatility, and support animal and plant health and traceability.

(3) Powers to make regulations setting and amending marketing standards for agricultural products and to make provision about the classification of carcasses by slaughterhouses.

(4) Provisions to create a domestic system of recognition of Producer Organisations to encourage collaboration amongst growers. These provisions will provide for exemptions from competition law for recognised organisations.

(5) Provisions for the Secretary of State to make regulations imposing obligations on first purchasers of agricultural products in relation to contracts with producers. This is aimed at protecting producers and consumers from unfair trading practices.

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Once the Bill becomes an Act of Parliament the following provisions will extend to England and Wales only:

(1) Part 1 which relates to new financial assistance powers
(2) Part 3 which relates to the collection and sharing of data
(3) Clause 20 which relates to the power to make regulations for marketing standards and carcass classification.

Schedule 3 extends mostly identical powers to the Welsh Ministers as those conferred on the Secretary of State in Parts 1-5 of the Bill.

Schedule 4 extends similar powers to DAERA (Northern Ireland) as those conferred on the Secretary of State in Parts 2-5 of the Bill.

The rest of the Act will extend to the UK. This is because the relevant provisions:

(a) Relate to a reserved matter; or
(b) Amend, or give powers to amend retained EU legislation which will extend to the UK. Such provisions may, however, apply more narrowly to a particular jurisdiction.

Annex A gives more information. Please refer to it for details re Scotland.

Brexit Law Tracker (UK)

UPDATE (6th Sept) : it is today confirmed around half of the new statutory instruments are needed in any event, and the rest are connected with the possible new UK-EU deal.

Four Brexit laws have Royal Assent and the Customs Bill (Taxation (Cross-border Trade)) passed its second reading in the Lords last night. No progress has yet begun on the Migration Bill, but all other Bills are underway or at White Paper consultation stage.

Some 800 new statutory instruments are now expected by February.

I will commence compiling in October the Brexit Law List for EHS Legislation Registers , so please look out for that appearing in systems.