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In many ways, the European Medicines Agency (EMA) has streamlined the market access of medicines for much of Europe. By standardizing the regulations, the current system has created centralized market access across all European Union (EU) member states, as well as non-members Iceland, Norway, and Liechtenstein. Transporting goods to and within the EU has been streamlined as well. For example, goods from outside the EU receive the same tariff when brought into any member state, and no tariffs or customs duties are applied to goods transported between EU member states.
Practically speaking, this means that pharmaceutical companies only need to follow one set of common rules to have a medicine authorized in the vast majority of Europe. However, there are situations in which the regulation of transport of medicinal products across European borders introduces complexities. This blog will explore some of these complex cross-border transport challenges, including the impact of Brexit, Northern Ireland’s unique situation, and transporting investigational medicinal products (IMPs) for clinical trials, along with strategies that sponsors can take to mitigate those challenges.
The Impact of Brexit
In 2020, the United Kingdom (UK) officially withdrew from the EU in a move commonly referred to as Brexit. With a now-separate medical regulatory organization, the Medicines and Healthcare Regulatory Agency, the UK may approve medicines for use that the EMA does not recognize, and vice versa. Those who wish to bring their medicinal products to the UK, as well as to the EU, must comply with regulations in both areas. Additionally, to bring a medicinal product to the UK from the EU now requires the application for separate licensure, such as marketing authorization.
Perhaps the most dramatic transport difference caused by Brexit is the institution of customs checks and border controls between the UK and EU member states, requiring such formalities as written declarations for imports and exports. These border controls have been slow to take effect. But, as they are implemented, they may lead to increased delays and supply chain disruptions, particularly for those products entering the UK. However, a trade agreement has ensured that there will still be no customs duties for medicinal products originating from the UK or EU, and intended for use in the UK or an EU member state.
Challenges in UK-EU medicinal transport are ongoing, even taking the blame for some drug shortages in the UK. Those pharmaceutical companies or clinical trial sponsors looking to ship medicines between the two should allow ample time for shipping. Nevertheless, a thorough understanding of the differences in pharmaceutical regulations between these regions can help to reduce delays. For example, by knowing and satisfying the differing batch-testing requirements that safeguard a medicine’s quality, a sponsor can ensure that the proper documentation is provided upon import.
Northern Ireland
Brexit has presented a unique challenge for Northern Ireland in particular. It was agreed in 2020 that Northern Ireland would remain under the EU’s medical regulatory system, despite being a part of the UK and still importing a large portion of its pharmaceuticals from Britain — creating a set of challenging requirements as it straddled the two systems.
This situation changed again under the Windsor Framework in 2023, which established new standards intended to facilitate transport and trade between Britain and Northern Ireland, including medicines. For example, all medicines approved in the UK may be imported for sale in Northern Ireland, and medicines can have the same packaging and labeling across the UK, including Northern Ireland, as long as packaging includes a clear “UK only” label.
IMP transport
With the global nature of many clinical trials, some clinical trial sponsors may wish to explore the possibility of conducting them in the EU, and, as a result, must manage the EU regulations surrounding the import of an IMP. Before an IMP is released for use in the EU, a qualified person — a licensed professional with experience in pharmaceutical manufacturing, who has taken qualifying examinations — must certify that the batch complies with the good manufacturing practices that are expected in Europe. The clinical trial must also be authorized by all member states in which the clinical trials will take place.
When transporting IMPs to EU member states, the clinical trial sponsor — or its representative — holds ultimate responsibility for the shipment until it is accepted at the clinical site or pharmacy, overseeing all storage and transport to safeguard the condition of the IMP. To ensure that the shipment follows regulations and sponsor specifications, it is important to keep rigorous documentation of information related to the shipment, such as the timelines required to maintain the supply chain, temperature control and storage condition records, and detailed inventory of shipments that includes the information of the addressee. In those cases in which a shipment departs from its specified conditions, the EMA calls for formal investigation.
Navigating regulatory complexities
Regulations for medicinal transport can be complex, and are subject to change, as technology and the understanding of medicine advance. Packaging and labeling must be compliant with regional requirements. Problems with document preparation or customs fees can lead to delays, or even the quarantine or destruction of a shipment. To help ensure the timely transport and delivery of biopharmaceutical shipments, contact Yourway and benefit from in-depth and country-specific knowledge of requirements around the world.