EU Market Access for UK Companies

The UK life sciences industry contributes over £30 billion to the UK economy, and supports almost half a million UK jobs. The UK is a leading centre of medical research and biopharmaceutical innovation and is at the forefront of drug development and approval. With the Brexit transition period ending in less than six weeks, the UK pharmaceutical industry is increasingly focused on taking actions to ensure the continuity of supply of their products to patients during this transition, and to ensure their companies’ long-term access to markets and providing products to patients throughout Europe. This has been made all the made difficult by Covid-19 and its devastating impacts.

What we know so far is that, from 1st January 2021, the following will occur:

• Marketing Authorisation (MA) holders, if held in UK, will have to be transferred to an EU or EEA country.
• Each consignment of UK-manufactured Active Pharmaceutical Ingredients (APIs) to the EU/EEA needs to be accompanied by an MHRA certificate of conformation to EU GMPs.
• Each batch of UK-manufactured drug product intended for the EU/EEA market will need to be released by a QP within the EU/EEA.
• Pharmacovigilance of drug products placed on the EU/EEA market will need to be managed from a location within the EU/EEA.
• There will no longer be unrestricted transport of goods between the EU and the UK.
• Expect added paperwork, transport delays, and likely customs duties.

HiTech Health can act as an extension to your internal team within Europe. We offer Qualified Person (QP) services for the batch release and supply of medicinal products that can save you time and money when compared to building this expertise internally in Europe. With existing customers in the UK, we can provide a team to enable all the EU activities including product importation, QP certification and management of supply chain through to your distributor.

For the importation of medicinal products from the Great Britain (GB) to the EU, HiTech Health can act as the Importer of Record (IoR) for your company. Movement of goods from GB to the EU will be classified as international movements. Therefore, such movements will require transit declarations and tariffs. These tariffs will depend on the provision of a product identification code and HiTech Health can fully support you with this process.

The support we provide will be tailored to your company’s needs. Please email us at info@hitech-health.com to request further information on the range of services we can provide.

We are pleased to officially announce the launch of our new website, which reflects our expanding role as a leading professional service provider to pharmaceutical, biotechnology and medical device companies.

We are highlighting our services for Advanced Therapeutic Medicinal Products (ATMPs – which include cell and gene therapies). As our business continues to expand, the goal with this new website is to provide clear visibility on our services and the cross-functional experts we have at HiTech Health to support your company’s needs. The website now details the wide range of capabilities we offer surrounding cell and gene therapy services and at our process development laboratory in Galway, Ireland. This state-of-the-art facility is open for business and we can perform activities ranging from process and analytical development to personalised training in the lab.

Visitors can explore the many services we offer to a diverse range of clients ranging from early stage pre-clinical companies to large multinational corporations. Our focus is on Operations (CMC) from early product development through to product launch, HiTech Health has the experts that can enable a successful product registration and launch. Our team have led the development, manufacture, and supply of multiple products including cell and gene therapies to patients in several countries. We provide quality and compliance, QP and regulatory expertise, our team can be an extension of your internal resources. You can read about these services and much more on the new website. Going forward, we will continue to communicate regularly on the latest industry news and insights, as well as upcoming events where you can meet some of our team.