Overview

On the 24^th December 2020, a Trade and Cooperation Agreement (TCA) was struck between the EU and UK. This is welcomed by the pharmaceutical industry as it helps with maintaining continuity of supply and flow of medicinal products as well as other products between EU and the UK.

From a high-level perspective there will be significant changes to customs procedures which came into effect from the 01^st January 2021. The most catastrophic disruption of a no deal scenario has been avoided and companies can now begin to invest in long-term future supply plans. One of the challenges companies now face is that they have had little time to adjust to the conditions of the deal which may cause initial delays and errors in certification, importation/exportation documentation, and transportation of medical products between the UK and EU and vice versa. The trade deal has significant consequences for the movement of medicinal products both to and from the EU. Let us have a look at these in more detail.

UK companies supplying product to the EU

The three primary areas where businesses should keep an eye out for changes include Transportation and Shipping, Regulatory and Quality and Compliance. Here is what you need to know.

Shipments of medicinal products from the UK to the EU no longer fall under the free movement of goods and therefore are categorised as a cross-border activity. There will be a requirement for additional paperwork such as customs declarations. Companies may need to use brokerage service providers which may result in an increased end user price of the product. Fortunately, the deal means there will be no tariffs placed on any products. UK companies will need to engage EU businesses to act as the Importer of Record (IoR) for products moving from the UK to the EU. It will be extremely important to ensure the correct paperwork is in order for shipments going forward, especially for products with a very short shelf that are being transport under strict time and temperature constraints.

From a regulatory perspective, there are two important things to note. Marketing Authorisation (MA) holders, if held in the UK, will have to be transferred to an EU or EEA country. Secondly, for products that are being imported from the UK to the EU, the EU site of batch release must be named on the MA.

Each batch of UK manufactured drug product intended for the EU/EEA market will need to be imported to a site of physical importation and released by a QP operating under an MIA within the EU/EEA. Until a Mutual Recognition Agreement is in place between the EU and UK, each batch of finished medicinal product must undergo, in an EU Member State, a full qualitative analysis, a quantitative analysis of all the active substances. Pharmacovigilance of drug products placed on the EU/EEA market will need to be managed from a location within the EU/EEA. This means the Qualified Person Responsible for Pharmacovigilance (QPPV) must also reside and operate in the EU/EEA from 1st January 2021.

EU companies supplying product to the UK

Transportation and shipping changes for EU companies supplying product to the UK looks similar to what was mentioned above with additional paperwork including customs declarations being the critical requirement going forward.

If EU companies wish to conduct clinical trials in the UK, the UK regulatory authority will require that exported product to the UK have a certification by a UK QP before it can be administered to a patient (1).

If you are the Sponsor of a UK clinical trial using IMPs imported from into the UK from countries on the ‘approved country for import’ list (initially, all EU and EEA countries) you will require a UK Manufacturing and Import Authorisation (MIA (IMP)) holder to put in place the assurance system to check these IMPs have been certified by a Qualified Person (QP) in a listed country, before being they are used in a clinical trial setting (1). IMPs will not require recertification, however. A wholesaler may only import certified medicines from the EU if the appropriate checks are made by the UK Responsible Person (RP). The RP must reside in the UK, as well as a number of other factors which can be found on the MHRA website (2). It is therefore important to engage with the right personnel in order to successfully put in place the infrastructure necessary to continue to supply medicinal products between the EU and the UK.

For more information on QP batch certification and importation, Importer of Record (IoR) and Responsible Person services, please contact the author Robert Hanly at rhanly@hitech-health.com or email info@hitech-health.com.

Contact us to learn more about HiTech Health.

References:

1. https://www.gov.uk/government/publications/importing-investigational-medicinal-products-into-great-britain-from-approved-countries/importing-investigational-medicinal-products-imp-from-countries-on-a-list-to-great-britain
2. https://www.gov.uk/guidance/acting-as-a-responsible-person-import

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.