COVID-19 Medicines (UK)

1st April, the UK medicines regulator has issued guidance for industry on regulatory flexibilities that apply to the production of medicines in the UK.

The Link is here (this link also links to other relevant guidance)

The regulatory flexibilities are too lengthy and complex to summarise here in this Blog. The reader is asked to use the Link and read the relevant sections.

The Chancellor has also waived import duties and VAT on medical imports – here.

EU Readiness Notices (EU Brexit)

The UK is exiting the transition period on 31st December.

The European Commission is reviewing – and where necessary updating – the over 100 sector-specific stakeholder preparedness notices it published during the Article 50 negotiations with the UK.

The documents (updated so far) are published as ‘notices for readiness’ for 1st January 2021 –

(1) Air Transport – here

(2) Aviation safety – here

(3) Consumer protection and passenger rights – here

(4) Cosmetic products – here

(5) Animal feed – here

(6) Food law – here

(7) Industrial products – here

(8) Medicinal products for human use and veterinary medical products – here

(9) Movements of live animals – here

(10) Online sale of goods with subsequent parcel delivery – here

(11) Plant health – here

The transition period ends on 31st December, unless it is extended by agreement.

Medicines and Medical Devices Bill (UK Brexit)

The (Brexit) Medicines and Medical Devices Bill 2019-20 was announced in the Queen’s Speech on 19 December 2019. The second reading is taking place today.

A large proportion of the legal framework for medicines and medical devices in the UK derives from EU Directives and has been implemented into domestic legislation through section 2(2) of the European Communities Act 1972 (ECA). This enables EU Directives to be transposed into UK law through secondary legislation and has been used to create a body of regulations that include the:

• Human Medicines Regulations 2012

• Medicines for Human Use (Clinical Trials) Regulations 2004

• Veterinary Medicines Regulations 2013

• Medical Devices Regulations 2002.

At the end of the Transition Period, the European Union (Withdrawal) Act 2018 (see the Brexit Law List in subscribers’ systems) will have preserved these frameworks as “retained EU Law”. Since the ECA is now no longer available (due to the Act that implemented the Withdrawal Agreement), there is no other ‘general power’ for updating these regulations from 1st January 2021, except through the introduction of new primary legislation.

The Medicines and Medical Devices Bill seeks to address this regulatory gap through introducing regulation-making, delegated powers covering the fields of

* human medicines,

* clinical trials of human medicines,

* veterinary medicines, and

* medical devices.

Its purpose is to enable the existing regulatory frameworks to be updated at the end of the Transition Period.

The Bill has been drawn to create ‘targeted’ delegated powers which can only be exercised in relation to a restricted number of matters. The Government states in the Explanatory Notes to the Bill that it intends to use these powers to keep the existing regulatory frameworks updated, while also consolidating the enforcement regime for medical devices. In addition, the Bill will provide the Secretary of State with the ability to impose civil sanctions – as an alternative to criminal prosecution – for breaches of the medical device regime.

Further details are set out in this Commons Briefing – here.

EU Law in UK 2021 (UK Brexit)

Exit day is 31st January (end of this month)

Implementation period completion day is 31st December (this is the end of the transition period)

The Chancellor speaking to the Financial Times, confirms there will be no dynamic alignment with EU Law after 2020.

I am not yet clear which laws will diverge, but please note the Brexit laws allow divergence, for example the Brexit Agriculture Bill provides for England, Wales and Northern Ireland to create their own marketing standards (Scotland will need to enact its own Brexit Agriculture Bill).

The EU Exit regulations (statutory instruments) we (Cardinal Environment) are consolidating into domestic law only deal with the pre-Brexit period to end Dec 2020.

It is the FT front page today (Saturday 18th January) and the lead on BBC online.

EU Law per se will not apply anyway. Note, there may be some long tail implementation left over from pre-Brexit that will be implemented.

We (Cardinal Environment) are already consolidating the EU Exit regulations into domestic law, and creating the Retained EU Law (EU Regulations, not Directives, that are adopted). Progress in this project can be seen by clicking the Brexit Consolidated Law List on the top right hand side of EHS Legislation Registers & Checklists homepages (both ENV and OHS).

We are working to the deadline of 31st December 2020 for completion of this project.

In addition, EHS Legislation Registers & Checklists will see the home page choice of ENV or OHS have additional Post-Brexit choices, and the existing links relabelled Pre-Brexit.

The Post-Brexit links will direct to shadow Registers & Checklists that will run from the end of Q1 to hit the end Dec 2020 deadline, for switch over to Post-Brexit.

Post-Brexit shadow Registers & Checklists running in 2020 will have Brexit Consolidated Law loaded (accessibility will stay from the main Brexit Consolidated Law list), and will display a changed Register layout.

Post-Brexit EHS Legislation Registers layout – EU Law will be moved from the top to below Guidance. We will still supply up to date EU Law to UK customers, but this is where it will be found. Retained EU Law will be displayed at the top of the Register.

Medical Devices Notified Bodies (UK Brexit)

Exit day is 31st October (this date is in a Statutory Instrument)

Yesterday (8th October) the MHRA updated its instructions on Notified Bodies.

Here

This link updates on notified bodies: UL International (UK) Ltd address, contact details and EC link updated, BSI Healthcare EC link added, SGS named contact updated and LRQA was removed from the list.

The link also has the published guidance on how medical devices will be regulated.

Medicines and MHRA Instructions (UK Brexit)

Exit day is 31st October.

The MHRA today updated its instructions for the regulation of medicines, medical devices and clinical trials after Exit.

Here.

Please see the link on this page to other MHRA instructions issued,

Please check for situations where this comes within the scope of the Brexit Law being consolidated by Cardinal into base law and supplied to subscribers to Cardinal Environment EHS Legislation Registers & Checklists.

UK Brexit Preparedness – Medicines (UK Brexit)

Exit day is 31st October (127 days)

Today, 26th June, sees the following :

(1) Ministerial Statement – here

(2) Letter to Suppliers re Medicines – here

Ministerial Statement – extracts

Guaranteeing the supply of critical ‘category 1’ goods, including medicines, medical products, veterinary medicines and chemicals remains an essential element of the Government’s No Deal contingency planning. The Government is therefore undertaking steps to secure freight capacity for suppliers of these goods in a No Deal scenario.

The Department of Health and Social Care is starting the process of setting up an express freight contingency arrangement to support continuity of supply of medicines and medical products. This will be an urgent contingency measure for products requiring urgent delivery, within a 24-48 hour timeframe, if the UK leaves the EU without a deal. This express freight contingency arrangement forms part of the Department’s multi-layered approach, which includes rerouting medical supplies from the short strait crossings, extra warehouse space, stockpiling, buffer stocks, clarifying regulatory requirements, supporting traders to have all necessary paperwork in place at the border, and strengthening the processes used to deal with shortages to ensure that patients have uninterrupted access to medicines and medical products if the UK leaves the EU without a deal. Government will only pay for capacity as and when it is needed and used. This will be designed to cover all of the UK. The Department will be writing to industry to set out further details of these preparations.

The Department for Transport is putting in place a freight capacity framework agreement that will provide government departments with the ability to secure freight capacity for our critical supply chains as and when required. This framework does not commit the Government to purchasing or reserving any freight capacity, but it does provide a flexible list of operators and options for the provision of the capacity that can be drawn upon if needed.

In the coming months, the Government will make further announcements on its preparations for a possible No Deal Exit on 31 October, including on trade continuity agreements to limit disruption to our trade with third countries after we leave the EU.

Letter to Suppliers re Medicines – extracts

All no-deal preparedness plans should contain a mix of the following, depending on each company’s specific situation:

–  Secured capacity for rerouting freight away from the short straits after no-deal exit day, in order to avoid the worst restrictions on flow outlined above.

–  Stockpiling product above and beyond business-as-usual inventory levels; as a default, this is recommended as six weeks’ stock above business as usual inventory, the same as last time.

–  Assurance on the readiness of a company’s logistics and supply chains to meet the new customs and border requirements for both import and export (sometimes referred to as “trader readiness”).

Where companies have not yet done so [made a plan] the Government asks that they build a plan which includes a stockpile of an additional six weeks’ supply in the UK, on top of operational buffer stocks, in addition to developing a robust re-routing plan away from the short straits. As before, for products with a short shelf life or where production constraints mean stockpiling is not possible, for example, medical radioisotopes, we ask for alternative air freight plans to be made.

In the coming days, companies will be asked to provide information at product level, focused on the minimum key data set necessary for assurance of the programme. This will build on information from the 29th March exercise, including stock levels expected to be held on 31st October and plans for re-routing away from the short straits.