BREXIT UPDATE BULLETIN

RE: IMPACT OF BPR and BREXIT on chemical pricing and packaging

As a company that works beyond the UK borders, we have naturally received communications from concerned customers and stakeholders as to how BREXIT may impact the supply of our goods.

Whilst we do not anticipate that the UK will leave the EU without a deal, it would of course be naive to rely on this assumption and therefore Medimark Scientific has been working with its supply partners for some time to review all eventualities. One element is relative clear at this stage, that the UK will continue to apply the Biocidal Products and Medical Device directives. As such and from a regulatory perspective, since our company trades with the UK, EU and countries outside the EU, we do not envisage any regulatory changes.

The greatest concern for customers and stakeholders is one relative to supply chain and logistics. All our liquid products and wipes are manufactured within the United Kingdom and any impact is likely to come from delays in raw material supplies to our manufacturers and shipping of goods outside of the UK. As such, we have been working closely with our supply partners to ensure that not only do they have the necessary resource and materials to manage any supply chain difficulties, but we are also reviewing our own stock-holding position. One of our key parameters of supply is also to ensure that our supplier partners have similar back to back arrangements with their suppliers. From the perspective of shipping, we will be advising new lead times for orders and recommend that overseas customers take a view on their own stock-holding position and lead time impact.

We are happy to discuss ways in which we could assist you to minimise any potential impact on your business at your convenience. In the meantime, please check in here regularly for updates.

23/08/18 - Advice from Gov.uk regarding medical devices in event of no deal - https://www.gov.uk/government/publications/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal

22/11/18 - Primary supplier confirms “limited impact on production capacity

30/11/18 - Update from Gov.uk on Biocides under Brexit - https://www.gov.uk/government/publications/regulating-biocidal-products-if-theres-no-brexit-deal/regulating-biocidal-products-if-theres-no-brexit-deal

19/12/18 - Medimark Scientific Brexit Regulatory Impact Statement relative to Medical Devices

02/01/18 - BBC Webiste - What could happen next?

04/01/18 - Latest news from UK Gov on Medical Devices in event of “Cliff Edge Exit”

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As voting in “the House” continues, negotiations move back and forth and there is still no clear position on a deal or no deal situation, our policy of planning for the worst has ensured that our major distributor partners are ready for a similar “worst case” situation. As such, our manufacturers are holding 3-4 months or raw materials, we hold elevated volumes of finished goods and have also adjusted our lead times to compensate for any delays in production, delivery / logistics or customs delays. In particular our medical device distributors hold suitable stocks pending the transition to a new EU Medical Device certification. Our existing EC certification (registered in UK) will transition to a UK certificate and we are proud that we have completed a recent audit to ISO13485:2016.

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12th April 2019 - Following the agreed extension to 31st October 2019, we are able to continue to place CE marked product on the EU market under the EN13485:2016 medical device certification. Our notified body LRQA has applied for an EU Accredited status and upon confirmation we expect to be able to file for a separate EU medical device certification, as following a formal Brexit agreement date our existing certificate will be converted to a UK Certification. We will be in contact with all our EU distributors over the next few months to ensure that sufficient stocks are held pending issue of a new EU certification.

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31st May 2019 - Following the recent developments we are now gearing up for BREXIT Take 2 where the same update is pertinent as given on 19th December 2018 although with dates moved to 31st October 2019 - Medimark Scientific Brexit Regulatory Impact Statement relative to Medical Devices

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6th August 2019 - We are still planning for a no deal BREXIT with our primary stakeholders, particularly regarding our medical device registered products. if you would like further advice on orders into the EU or impact upon manufacturing please email export@medi-mark.co.uk. For any regulatory questions concerning how BREXIT will affect our products please email regulatory@medi-mark.co.uk.

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6th September 2019 - useful flow chart from BBC on the latest developments in UK Parliament - https://www.bbc.co.uk/news/uk-politics-46393399

9th September 2019 - Medimark Scientific continues to plan for a NO DEAL scenario and to manage EU medical device expectations for placing product on the market. Whilst we covered by MHRA during the interim period we are now working with EU registered bodies to enable a medical device registration through EU accredited body..

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