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Why you need an Importer of Record: EU to the EFTA and the UK

Ruchundre Reid

February 10, 2023

Clinical trial deployments are difficult to navigate, especially if you must deal with intricate customs regulations without an expert IOR to assist. This is true even for regions, like the EU, with historically minimal shipping restrictions on goods. Due to recent changes in regulations and new political developments occurring in Europe, importing between the EU, EFTA, and the UK has become increasingly complex.

Clinical trials are essential to developing new drugs, treatments, and medical devices, and ensuring the smooth transportation of trial materials between countries is vital. As experts in the field of clinical trial deployments, we at TecEx Medical have seen complications arise, resulting in stuck shipments due to multiple reasons, including:

- The trial site is listed as the IOR.

- Missing or incorrect documents.

- Inexperienced or uninformed IORs.

- No dedicated IOR is listed to take responsibility for the medical goods.

While these reasons for stuck shipments apply to any deployment across the globe, importing between the EU, the EFTA, and the UK has added misconceptions and regulation challenges unique to the region. Unless there is a specific agreement, your goods will need to be cleared through customs if you are shipping between two countries. This includes shipping from an EU member state to an EFTA state like Norway or Switzerland, where an IOR and customs clearance will be required.

In this blog post, TecEx Medical will examine the complications involved in deploying to the EU and why an Importer of Record is needed to ship medical goods from the EU to the EFTA and the UK.

Why do you need an IOR to ship from the EU to an EEA EFTA state?

In the case of the EFTA states of Iceland, Liechtenstein, Norway, and Switzerland, shipments may get stuck in customs more often due to the misconception that they are part of the EU. However, these countries are not part of the EU but are part of the European Free Trade Association (EFTA) and have unique customs procedures.

The European Economic Area (EEA) unites the EU 27 Member States and three EFTA States – Iceland, Liechtenstein, and Norway – into an internal market governed by the same basic rules. These rules aim to enable goods, services, capital, and persons to move freely about the EEA in an open and competitive environment, otherwise known as the four freedoms.

While goods can be transported between EU member states without customs control and payment of duties and taxes, the same cannot be said for EEA states.

A host of EU policies, processes, and procedures are not covered by the EEA Agreement, including the Customs Union, which has a massive impact on the import and export landscape between the EU and the EFTA.

Others include:

Customs Procedures: Each EFTA country has its own customs regulations, which vary from the EU’s Union Customs Code (UCC). For example, the customs regulations in Norway are governed by the Norwegian Customs Act and the Norwegian Tariff Act.
Regulatory Bodies: Unlike the EU’s centralized European Medicines Agency (EMA), each EFTA country has its own regulatory body to supervise clinical trials. For example, in Iceland, the regulatory body for clinical trials is the Icelandic Medicines Agency.
Data Protection: Each EFTA country has its data protection regulations, which vary from the EU’s General Data Protection Regulation (GDPR). For example, in Liechtenstein, the data protection regulations are governed by the Liechtenstein Data Protection Act.

Furthermore, on 31 January 2023, the new Clinical Trials Information System (CTIS) established by EU Regulation on clinical trials (CTR) was rolled out and became mandatory.

In a nutshell, pharmaceutical companies sponsoring clinical trials in the EU should be aware that:

Clinical trial applications must now be lodged through the CTIS.
The CTR imposes increased transparency obligations. All data regarding clinical trials authorized through the CTIS must be made publicly available unless confidentiality is justified to protect commercially confidential information (CCI) or protected personal data (PPD).
The use of the CTIS system and the applicability of the transparency requirements will have a major impact on companies sponsoring clinical trials in the EU, allowing for the first time the general public – as well as competitors – to access an unprecedented volume of data regarding the development and investigation of medicinal products.

Because the EEA does not cover the EU Customs Union and other customs procedures, importing goods to an EEA EFTA state from an EU country will be subject to customs duties and taxes. Thus, your goods will require an importer of record to be listed on the commercial invoice and take on the responsibility of the shipments to undergo customs clearance.

While Switzerland is part of the EFTA, it is not part of the EEA Agreement. Thus, Switzerland has its own set of bilateral agreements with the EU – which has recently become a sore point since the lapse of the Swiss Mutual Recognition Agreement (MRA) for medical devices in 2021.

The Effects of Swixit on EU Trade and How to Clear your Swiss Shipment

Recent political changes between the EU and Switzerland, known as Swixit, have significantly impacted the MedTech industry and clinical trial studies.

Many Swiss companies have traditionally delivered medical devices to their respective EU distributors directly from Switzerland. Under the EU Medical Device Regulation (EU-MDR), Switzerland is considered a third country, and recipients of these devices fit the definition of an importer. As a result, they would need to comply with the regulation, and the importer would need to be identified on the customer invoice. Other factors to consider while importing between the EU and Switzerland include:

Regulatory Processes

Unlike the EU’s centralized regulatory system for clinical trials, Switzerland has its regulatory process for clinical trials. All Swiss clinical trials require approval from the Swiss Agency for Therapeutic Products (Swissmedic).

Classification, Labeling, and Packaging of Chemicals

Switzerland has its regulations for the classification, labeling, and packaging of chemicals governed by the Swiss Chemical Ordinance and varies from the EU’s CLP Regulation.

No formal Institutional Framework Agreement in place

In 2021, the Federal Council of Switzerland (Swiss Executive Authority) announced that they would not formally sign the institutional framework agreement (IFA), thereby ending the negotiation process. Consequently, upgrading existing agreements will be assessed on a case-by-case basis to prevent unintended effects. Medical device equivalence, previously covered by provisions of the EU-Swiss Mutual Recognition Agreement (MRA), is the first no longer to be applied because of changes in EU standards.

As a result, until a potential agreement on the proposed modification to the MRA is reached, the trade facilitating effects of the MRA for medical devices, including the mutual recognition of conformity assessment results, the absence of the need for an authorized representative, and the alignment of technical regulations, ceased to apply.

Thus, enlisting the services of an IOR with expert knowledge of Swiss shipments and imports would help avoid your goods from getting stuck at customs. TecEx Medical can help you navigate the complex customs regulations of Swiss importing and take on the responsibilities of being your medical IOR specialist.

Brexit’s Impact on Clinical Trials between the EU and the UK

The United Kingdom (UK) ceased to form part of the EEA after withdrawing from the European Union in 2020. This, in turn, voided all trade agreements between the UK and EU, disrupting the supply chain between the two areas.

Due to Brexit, EU companies importing medical goods into England, Wales, and Scotland must now declare their shipments to UK customs and follow the proper shipping procedures to ensure customs clearance.

With the UK now outside of the EU, there are regulatory, compliance, and governmental differences to consider when importing, which include:

The requirement for an Import-Export Declaration (IED) – an official document that must be submitted to customs authorities to import or export goods
Different requirements for product labeling, packaging, and import duties
Different regulatory requirements
Compliance with data protection regulations
Adjustments to supply chain and logistics
Increased costs

The implications of Brexit, such as regulations and customs procedures changes, can lead to shipments getting stuck in customs. This is because of the added complexities in navigating customs regulations and the need for compliance with new regulations, which may not have been in place previously. This can result in additional paperwork, increased scrutiny, and longer processing times at customs, leading to delays and potentially causing shipments to get stuck in customs.

Therefore, you will need an IOR for all clinical shipments from any EU member state entering the UK. Our TecEx Medical team simplifies deploying to the UK by acting as the dedicated medical IOR of your goods.

Why it’s best not to list your Trial Site as the IOR

Listing the trial site as the IOR can lead to several complications, including additional responsibilities, costs, and liability. It’s best to appoint a professional IOR specialist who is experienced in handling customs and regulatory requirements. This reduces the burden on the trial site and minimizes the risks involved in the shipping process.

We had seen complications occur when a shipment from the EU needed to go to a site in Norway, and the Norwegian site was listed as the IOR. The goods got stuck at customs, and the shipment had to be returned to the sender due to the absence of necessary import information.

TecEx Medical was subsequently contracted to act as IOR for the new shipment, and we successfully cleared it through customs. If TecEx Medical were the IOR originally, the goods would have enjoyed first-time clearance. Unfortunately, due to the delays of the first shipment, the goods were not at the site in time for the Site’s Initial Visit (SIV) date, causing further delays to the study and additional costs.

To avoid stuck shipments and increase your chances of first-time clearance, enlist the services of an IOR specialist – like TecEx Medical – to take care of your shipment and all the associated risks.

Key things to remember

1

An IOR is necessary to ensure customs clearance for all clinical deployments from an EU member state to the EFTA or the UK.

2

The EEA unites the EU and three EFTA countries but does not cover the Customs Union, so imports to and from the EU will be subject to customs duties and taxes.

3

Switzerland has bilateral agreements relating to import and export with the EU.

4

The UK’s customs regulations have become more complex after Brexit.

5

To ensure first-time clearance and avoid delays in your clinical trial, seeking out IOR experts and researching can save you time, money, shipment delays, and unnecessary legal, financial, and audit risks.

TecEx Medical Solution

Do you need to import your clinical goods to an EFTA state, such as Norway or Switzerland, or the UK, from an EU member state? TecEx Medical is a specialist Importer of Record (IOR) that can distribute your clinical trial supplies across outbound EU borders. As the assigned IOR, we take on all the responsibility, from taxes and duties to documentation, and project management of the shipment, so your commodities arrive safely and on time.

Our TecEx Medical team simplifies deploying to the EFTA and the UK by acting as the dedicated medical IOR of all your goods.

Reduce your responsibility and avoid stuck shipments by contacting TecEx Medical today.