BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now

Overview

The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.

The UK, by definition would become a "third country". Preparing for the withdrawal doesn't just involve the Healthcare Authorities, but every manufacturer and /or license holder of a pharmaceutical, biologic, medical device or combination product in the UK and EU.

Marketing Authorization holders of centrally authorized or mutually authorized [MRP /DCP] product licenses for pharmaceuticals and biologics along with CE-marked medical devices for human or veterinary use will have legal repercussions when the UK exits the EU. While there is still considerable uncertainty in a withdrawal agreement, there is now enough known about the likely implications that manufacturers and license holders need to start making plans NOW, so they don't find themselves in Non-Compliance with the new legal framework.

Learning Objectives

• Upon completion of this course, attendees will be able to accurately determine how Brexit will affect their operations and existing licensed Life Science Products in the UK and EU
• It will allow companies to make plans on becoming compliant on "What is Known" and to remain agile as the rest of the implications become clearer

Course Agenda

• EU Regulatory and Legislative Structure [with and without the UK]
• Issued Laws: Directives vs. Regulations
• Impact on Filing Registrations with EMA in Q1 2019
• Brexit Impact on License Holders Established in the UK
• What if my EU Authorized Representative is Located in the UK?
• What if the QPPV Resides in the UK?
• What if API Manufacturing is Located in the UK?
• What if Finished Product Manufacturing is Located in the UK?
• What if Batch Release is Done in the UK?
• What's the Effect on Generic or Hybrid Licenses Against a Reference Product Authorized in the UK?
• What's the Effect on More Specialized Products Like Herbal Medicines or Orphan Drugs?
• How Will the UK's Withdrawal Effect the Sunset Clause?
• What's the Effect Difference on Nationa or Mutual Recognition [MRP /DCP] Licenses vs. Centrally-Licensed Products?
• How is Brexit anticipated to Effect CE Certification or ISO-13485 Certification on Medical Devices?
• Wrap-Up and Q&A

Who Will Benefit

This workshop will be of great value to companies manufacturing in the UK /EU or holding Marketing Authorizations in the UK /EU. It is primarily designed to benefit personnel within the following disciplines:

• Executive & General Management
• Legal
• Regulatory Affairs
• Quality Assurance
• Manufacturing /Distribution
• Clinical Research
• Product Development
• CROs
• Consultants