The United Kingdom voted to leave the European Union in 2016, but it wasn’t until December 24th 2020 that the details of trade between the two countries was solidified. On that date, the two entities signed a 1,250-page Trade and Cooperation Agreement (TCA) that came into effect on January 1st 2021, and laid out the guidelines, rules, and regulations concerning commerce. Even though this agreement was drawn up after months of negotiations, the ripple effects are yet to be seen, and the changes in the economy and the healthcare industry due to COVID-19 will only make this transition rougher. Many in the pharmaceutical sector have been waiting to see what the guidelines would be, and in this article, we go over some of the implications of the rules laid out in the TCA.
While the TCA lays out some provisions to facilitate the smooth transition of trade between the countries, there will be a lot of impediments that did not exist before. Across the UK, many companies have been trying to figure out how to untangle themselves from years of EU integration. So far the industry has enjoyed the synchronized processes in the two entities, including cross-border procedures and supply chains. Now, since they will function as separate regulatory and legal entities, companies operating in both the UK and the EU will have to comply with two different set of rules, which will add to costs and possibly cause delays in logistics.
While there is an Annex in the agreement that concerns pharmaceutical products, but there are still many regulatory and trade issues that have not been addressed and which will still need to ratified. There are a few provisions that are intended to facilitate the smooth operation of trade by recognizing and removing unnecessary technical hurdles, and fostering cooperation on international scientific and technical guidelines. International standards will continue to be the base for all further technical regulations and inspection processes. The TCA also adds a mandate stating that both parties should have a free flow of information on product safety and compliance. Following are some of the areas of regulation laid out in the TCA that UK-based pharmaceutical companies should pay close attention to.
Manufacturing Practice: The TCA also lays out provisions for the mutual acceptance of GMP, or Good Manufacturing Practice inspections of manufacturing centres for medicinal products. It states that the two parties ““shall recognise inspections carried out by the other Party and shall accept official GMP documents issued by the other Party,” but allows for the rejection of these documents under certain circumstances. For example, one body may accept GMP documents by the other for establishments located outside their territory, but can set their own terms and conditions for this acceptance. They can also choose to conduct separate inspections of establishments certified compliant by the other party, but this can only be done by issuing a notice of intent to inspect which must be accepted. The other party can also choose to join in on the inspection.
Product Batch Testing: When it comes to product batch testing, the UK will accept batch testing and Qualified Person certification passed in the European Economic Area (EEA) until January 1, 2023, giving companies operating in the EU a two-year grace period. However, this does not extend both ways, and the EU will not accept batch testing done in the UK. A Qualified Person in the EEA will conduct and validate each batch of finished product before release in the EU.
Marketing authorization and new products: Every product manufactured needs a license to be sold in the market. The Medicine and Healthcare products Regulatory Agency is the licensing authority in the UK, but post Brexit, this license will not be recognized in the EU, and therefore UK pharmaceutical products may have trouble being validated for sale in the EU. However, in lieu of the broken UK-EU partnership, the UK has looked elsewhere to foster relationships. They have joined the Australia, Canada, Singapore and Switzerland Consortium, effective January 2021. This partnership will henceforth be known as the Access Consortium. On the subject of new medicines, there is uncertainty in the UK’s ability to participate in European clinical trials. The MHRA has laid out the UK requirements for the registration of clinical trials, and importing of Investigational Medicinal Products which came into effect after December 2020, once the post Brexit transition period ended.
Effect on Logistics and Supply Chains: Updated procedures for immigration and customs can lead to delays in medicines clearing border checks, leading to the expansion of lead times. Supply plans and logistics efforts need to be overhauled to allow for these changes.
Ultimately, while there are undoubtedly going to be upheavals because of Brexit, companies should not lose hope. The formation of new rules can give rise to new opportunities, more streamlined procedures, and more commerce-friendly regulations. There is still a lot of changes happening in the landscape of Brexit negotiations, and while it may be a daunting task, companies operating in this field should keep an eye out for any upheavals.
This is where Cosmotrace can help companies trying to keep abreast of the changing regulations. Our entire team at CosmoTrace has kept up with all the updates and is aware and well-equipped to navigate through the relevant requirements. Contact us today for help managing serialisation and supply chains in a post-Brexit economy.
CosmoTrace was formed by an expert, experienced team that has since worked extensively with every part of the pharmaceutical supply chain from manufacturing through to final distribution. As Serialization Consulting Experts, our focus is on delivering the absolute best serialization support by offering long-term serialization and sustainability strategies and providing forward-thinking industry solutions.
We offer premium support and services that can help your business with serialization implementation. Our team of experts ensure that you are up to date with all global traceability regulations and will help in creating a successful long-term serialization strategy.