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.