With the transition period for the United Kingdom to leave the EU now over, you may be wondering how this change will affect the way your products are regulated in the UK.

With offices in both the UK and the EU, we’re on hand to help you navigate new regulations and directives. Here are just a few examples of how your business and regulatory responsibilities may be affected by Brexit. If in doubt, we can help review your specific portfolio of products.

The first question you may have is whether you will need to appoint a Responsible Person in either jurisdiction. A Responsible Person is appointed to ensure that your company has a person responsible for your cosmetic products within the designated jurisdiction whether the UK or the EU. 

The Responsible Person, or RP, must be based within the legal jurisdiction and with offices in both the UK and the EU, we’re on hand to help you navigate new regulations and directives and to provide an RP where required.

In the UK, CBD products are classed as a novel food, and, as in the EU, in order to sell your CBD products in the UK you must obtain a novel food validation from the FSA (Food Standards Agency) by 31st March 2021.

To do this, you need to submit a novel food application before this date. This is a rigorous application which must be structured to the EC specifications in order to be authorised. But don’t worry, help is at hand – we provide a full CBD novel food application including product testing and application generation and submission to the FSA. Click here to learn more.

The biggest change to nicotine regulation is that instead of using the previous EU-CEG gateway for all TPD notifications, if you wish to sell your nicotine products within Great Britain you will now need to submit them through the new MHRA portal (the requirements and format are very similar to that of the EU-CEG system).

Although it is part of the UK, TPD notifications for Northern Ireland will continue to be submitted through the EU-CEG gateway. More details can be found in our blog post about how Brexit will affect e-cigarette regulation.

We offer a full TPD notification service for products to be notified in both the UK (GB and NI) and EU. Click here to learn how we can help.

For both UK manufacturers and those wanting to sell their pharmaceuticals within the UK, Brexit is expected to have a huge impact on the way their products are regulated. How will Brexit affect your regulatory responsibilities if you sell pharmaceuticals?

In particular, changes to clinical trial applications and ethics guidance for the UK have been made by MHRA, as well as updated guidance on packaging and information leaflets and marketing applications. Furthermore, changes to the importation and release of medicinal products have taken place.

If you need help in complying with the new requirements issued by MHRA, whether you’re based in the UK or somewhere else in the world, we can help. Click here to learn how our pharmaceutical regulation service can help you.

To market a medical device in the UK, you need to get your device certified and conformity marked before registering it with the MHRA. Similar to tobacco product notifications, cosmetics and other regulations, Northern Ireland has different rules to Great Britain in order to avoid issues crossing the border between the two parts of Ireland. A UKCA mark will replace CE markings for medical devices sold in Great Britain (England, Scotland & Wales). For Northern Ireland, a NICE mark will be applicable in place of an (EU) CE mark. 

CE marking will continue to be recognised in Britain until 23rd June 2023, but the EU no longer recognises UK Notified Bodies and they will no longer be able to issue CE certificates (outside of the UK and Northern Ireland), with UK Approved Bodies now taking this role.

If you are a manufacturer based outside of the UK looking to place a medical device on the market in Britain, you will need to appoint a UK Responsible Person.

If these new regulations seem confusing, help is at hand. Our expert regulatory affairs team will walk you through the requirements and can even complete regulatory compliance on your behalf so you can sell your products in the UK with confidence. Contact cara.leach@inter-scientific.com to learn how we can help you.

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