Arcinova Brexit Planning
As a British CDMO operating internationally, we are committed to doing everything within our control to minimise the impact of Brexit on our customers.
With high levels of uncertainty surrounding the outcome, Arcinova is preparing for the worst-case scenario, a ‘No Deal Brexit’.
This communication presents some of the plans and preparations that Arcinova is making to mitigate the risks and safeguard continuity of supply of its products and services to our customers.
The key areas of contingency planning are:
Supply Chain Stability
We maintain relationships with over 500 suppliers in the UK, Europe and around the world. This delivers enormous reach and flexibility in terms of maintaining supply chain stability and offers us alternative product sources in the event of any supply failures. A review of supply chain has taken place and all critical vendors have been contacted to ensure that their Brexit strategy is defined and acceptable.
The formal risk assessment of our supply chain ensures that we understand potential pitfalls and problems that may occur in the event of a no-deal/ hard Brexit. We will continue to work in close partnership with our suppliers to ensure best possible continuity of service and supply.
Continuity of Supply
Planning and information are key, and we encourage all of our customers to highlight any specific concerns and/or queries. Due to our longstanding experience, Arcinova will deploy various inventory solutions, as required, to maintain continuity of supply. Both Arcinova and our key suppliers will continue to review the potential for delays and where necessary and appropriate, we will increase stock holdings and/or flex our order cycles to maximise continuity of service.
Movement of Product
Arcinova has extensive in-house expertise for both import and export given that we currently source or supply product to and from Europe and the rest of the world. This includes expertise and relationships in areas such as freight forwarding, home office and regulatory affairs. In addition, we maintain multiple UK/Pan-European relationships with carriers which maximise our ability to supply critical products.
Supply of Investigational Medicinal Products (IMPs)
Supply of IMPs for clinical trials within the UK will be unaffected and will continue to be released by our QPs in line with our licences. Release and supply of Investigational Medicinal Products (IMPs)/Investigational New Drugs (INDs) for non-EU countries will be unaffected.
For supply of IMPs to clinics based within the EU after Brexit, the EU based sponsor holding the clinical trials authorisation will be required to employ a QP based in the EU to be responsible for the final release of an IMP/IND.
Products and Services
The situation regarding tariffs is still currently unclear, however Arcinova is committed to minimise any potential adverse cost impacts to our customers wherever possible.
Finally, Arcinova is founded upon the principles of flexibility and agility in serving our customers. In simple terms, this means that adjustments to our systems, working practices and delivery mechanisms can be assessed and implemented quickly to ensure the best possible solutions for our customers.