Sweden has a robust regulatory framework for clinical trials, which creates hurdles for sponsors and CROs looking to import trial goods and products. Importing clinical trial products to Sweden can be complex, with a range of regulatory, logistical, and financial challenges to navigate. These challenges include:
- The Influence of the EU on Swedish Clinical Trials
- Obtaining Swedish Regulatory Compliance for Clinical Trials
- Navigating Custom Clearance in Sweden
- Understanding Swedish Import Taxes and Duties
- The Importance of Transportation, Logistics and Quality Control
Swedish imports may be a challenge, but with the right strategies and partners, it can be a “Swede” success story. This blog will explore key challenges for importing to Sweden and how an expert medical IOR can ensure a successful outcome.
1. Influence of the EU on Swedish Clinical Trials
As a member of the European Union (EU), Sweden participates in the EU’s regulatory framework for clinical trials. The EU has established a centralized regulatory system for clinical trials that is governed by the European Medicines Agency (EMA). It is designed to ensure consistency and harmonization across member states.
Clinical trial sponsors can now submit a single application for a trial to the EMA. The EMA then conducts a scientific assessment of the application. If the trial is approved sponsors can then apply for authorization to conduct the clinical trial in each applicable state. The authorization process is overseen by the national regulatory authority in each member state. In Sweden’s case this is the Swedish Medical Products Agency (MPA).
The EU regulatory framework also includes guidelines and regulations for the conduct of clinical trials, such as the Clinical Trials Regulation (CTR) and the Good Clinical Practice (GCP) guidelines. These guidelines set standards for the design, conduct, recording and reporting of clinical trials in the EU, and aim to protect the safety and well-being of trial participants and ensure the reliability and credibility of the trial’s results.
Impact of the Clinical Trials Information System Roll Out
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 – including Sweden – 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.
As an EU member state, Sweden follows these regulations and guidelines in the conduct of its clinical trials. However, Sweden also has its own requirements and regulations that sponsors and CROs need to be aware of to conduct a trial in the country.
2. Obtaining Swedish Regulatory Compliance for Clinical Trials
Sponsors and CROs need to ensure that all clinical trial goods and ancillary products comply with Swedish regulations. These regulations cover areas such as importation procedures, labelling, and documentation. Regulatory compliance is a critical concern when importing clinical trial goods and ancillary products to Sweden.
The Swedish MPA and GCP guidelines are two key regulations that all clinical trials in Sweden need to comply with when importing goods and ancillary products. The Medical Products Act regulates the production and distribution of medical products, including clinical trial products. GCP guidelines, on the other hand, provide a set of international ethical and scientific quality standards for the whole life cycle of clinical trials.
Failure to comply with these regulations may result in the goods being delayed at customs or rejected altogether. To ensure compliance, sponsors and CROs need to prepare and maintain detailed documentation that demonstrates regulatory compliance. Documentation may include:
- Study protocols,
- Informed consent forms
- Investigational medicinal product dossiers (IMPDs)
- Case report forms.
Additionally, sponsors and CROs should engage with local regulatory experts and the Swedish MPA to obtain the necessary approvals, permits and licenses.
3. Navigating Custom Clearance in Sweden
Clearing customs is another concern when importing clinical trial goods and ancillary products to Sweden. Custom clearance procedures may vary depending on the type of product, its value, and its country of origin. To ensure smooth customs clearance, sponsors and CROs should ensure that all necessary customs documentation, such as the clinical trial application and IMPD are completed accurately and efficiently. Sponsors should also be aware of any duties and taxes that may be levied on the products and work with a trusted advisor to guarantee compliance with Swedish tax laws.
4. Understanding Swedish Import Taxes and Duties
Understanding and complying with taxes and duties is an important aspect when importing clinical trial goods and ancillary products for clinical trials in Sweden.
The Swedish Value-added tax (VAT) and customs duty are the two primary taxes applicable to clinical trial products imported into the country. The standard VAT rate in Sweden is 25 percent. However, clinical trial products may be eligible for a reduced VAT rate of 12%. To qualify for the reduced rate, the clinical trial must be approved by the Swedish MPA and the products must be used exclusively for the trial.
Swedish duty rates vary depending on the product’s classification and country of origin. Sometimes, clinical trial products may be exempt from customs duty if they are used solely for scientific research or clinical trials.
Sponsors and CROs should also consider any available tax exemptions and deferrals for clinical trial products and apply them when appropriate. For example, importers can apply for reduced customs duty or exemption if the goods originate from a country with which EU has a free trade agreement, or in the case of:
- Temporary importation (e.g., testing or exhibiting purposes).
- Inward processing when a product is imported to be processed further, repacked, and re-exported.
- Scientific instrument imports.
To reduce tax and duty-related delays or issues, sponsors and CROs should provide complete and accurate customs documentation. This includes clinical trial applications and IMPD invoices, and packing lists for clinical trials in Sweden.
5. The Importance of Transportation, Logistics and Quality Control
Transportation, logistics and quality control are interdependent issues when it comes to importing clinical trial products to Sweden.
To maintain the quality of the clinical goods during transportation and storage, it is essential to adhere to the manufacturer’s instructions and all relevant regulations, particularly those pertaining to temperature control. These regulations include guidance from the MPA or the EMA, and from industry standards such as Good Distribution Practice (GDP). Adhering to these regulations is essential for the safe and effective transport and storage of clinical trial products.
Quality control is critical for the safety, efficacy, and quality of the products. To achieve this, sponsors and CROs should develop a comprehensive quality control plan that includes product inspections, tests, and certifications. They should also confirm that the storage and transportations’ temperature and humidity levels are monitored. Specialized packaging, such as insulated containers, can be used to protect the products.
If the products are transported in conditions outside the recommended temperature and humidity range, the products’ quality and effectiveness may be compromised, potentially affecting the outcome of the clinical trial, and causing unwanted delays. Thus, sponsors and CROs need to align their transportation and logistics processes with their quality control plan and the manufacturer’s instructions.
These import concerns require careful attention to ensure a successful clinical trial and to avoid delays. Therefore, sponsors and CROs need to partner with an expert and specialized medical Import of Record.
Work with an Expert Medical IOR
An Importer of Record (IOR) is the party who is legally responsible for ensuring that imported goods comply with all regulations and laws in the destination country. As a medical IOR experienced in Swedish clinical imports, TecEx Medical can provide valuable support to sponsors and CROs, including:
- Importing and exporting of medical devices and trial materials
- Handling tax and duty complications
- Managing supply chain and logistics from start to finish
- Project management and strategic advice for proper clinical trial planning support
- Mitigating compliance risks that could delay trial approval.
Overall, an IOR can be an invaluable partner for sponsors and CROs importing clinical trial and ancillary products to Sweden. IORs provide local expertise that reduce the challenges associated with clinical trial deployments, allowing sponsors to focus on their research.
Make clinical deployments in Sweden easier by contacting TecEx Medical today.
