BREXIT UPDATE

UPDATED: 31 jANUARY 2020

Dear CCPS Clients,

It’s the eve of Brexit. As the EU and the UK get ready to part ways in some of the familiar areas of the common market, there is no doubt there are some concerns among many as to “What this will really mean?”

The answer is “We don’t really know.”

However, CCPS is ready to embrace and react to whatever may come.

What is known?

  • As of 12:01AM 1 February 2020, the UK will officially come out of the common market.
  • The initial DRAFT changes on how key industries will operate and any changes to current processes, including tariffs, will begin to be released for comment starting in February.
  • The UK will continue to operate as normal within the common market until December 2020, at which time the new rules and guidance’s will become requirements.
  • Finialisation of any new Brussels-based legislation, in relation to the space CCPS operates in, will continue for many years. As this is a historical first, the dynamic nature of the changes will continually be assessed for suitability.
  • Individual countries will also be assessing options; several countries have already made it clear they are not going to change the current system regarding drug/device release (QP process), clinical trials, IMP management, product approval, and pharmaceutical/device regulation; which are in place and currently being followed by everyone. They will implement national legislation to ensure things continue as they are today. In short, irrespective of EU revisions, many member states have made it clear it will be “business as usual” in this space for years to come. It is medical research and patient healthcare first, political infighting second.

During this time, CCPS will be operating as normal around the world, and we will continue to provide the same, world class service, in all areas of our business, including:

  • Global Packaging and Labelling
  • Global Advance Access to Treatments
  • ULM
  • Comparator sourcing
  • Global Consulting
  • Product development
  • Clinical trial design and support
  • IMP and ancillary supplies management
  • Clinical introduction programs
  • Healthcare Logistics

You can rest comfortably that we are actively involved with governments and committees associated with the changes, and we will continue to ensure that the needs and interests of patients around the word are kept as a priority and any changes to requirements which impact our clients and customers are handled seamlessly.

If you have any questions, please do not hesitate to reach out to your CCPS contact, or directly to CCPS Global Regulatory at brexit@calcog.com.

On behalf of Caligor Coghlan Pharma Services, the undersigned executive has approved and issued the foregoing statement as of the 31st day of January 2020 and has instructed that it be posted on the Company’s website.

Geoff M. Fatzinger
Global Vice President, Regulatory Affairs

Caligor Coghlan Pharma Services
US: 1500-B Business Park Drive l Austin, TX, 78602
UK: Unit 8 Masthead, Capstan Court l Crossways Business Park, Dartford, DA2 6QG