June, 2017- The countdown has begun.
The United Kingdom is set to leave the European Union by March 2019 at the latest. Will you wait to see what the impact will be and hope your trial is not disrupted? Or will you take preemptive action and choose CSM to manage your clinical trials within the future European Union and mitigate the risk now?
It is likely that UK-based QPs will no longer be able to certify clinical trial batches for the European Union. With 25% of the European Union's QPs based in the United Kingdom, it is possible there will be a shortage of qualified QPs after Brexit.
> CSM can help you avoid disruption to your trials and costly delays.
What will happen to clinical trials starting now that take longer than the 2 year Brexit deadline to complete? Will you have to change your QP, packaging & distribution vendor in the middle of the study and, as a consequence, have to redo the assessments, audits, batch reviews and contracts with a new QP?
> CSM, with facilities and QPs firmly in the heart of Europe, is ready and able to handle your clinical trials, no matter how long they take to complete.
As the UK transitions out of the EU, there are potential exchange rate and customs issues that could adversely affect your business.
> As the only provider with two established sites in the post-Brexit EU (Belgium and Germany), CSM offers an instant solution.
Latest EC/EMA news on the subject.
The European Commission and the European Medicines Agency have also published a short Q&A on the impact of the UK withdrawal from the EU with regard to medicinal products. Their note confirms that on 30 March 2019 the UK will become a 'third country', and confirms that companies based there will no longer enjoy the privileges of EU membership, and all that this implies. See the link here.
Read more about
CSM QP solutions and European capabilities:
check out our case study on
EU Release and the importation of IMPs in the European Union