The Pharma and Biotech industry is likely to be significantly impacted by Brexit. The joint notice and Q&A document from EMA and European Commission along with the notice from the CMDh in May have provided an indication of the changes that the Pharma and Biotech industry will need to undergo to meet the new landscape.
For EU/EEA licences there will be an impact on the Marketing Authorisation Holder (MAH) and pharmacovigilance activities. If you are significantly exposed by these changes, then proactive planning ahead of the 30 March 2019 timeline is recommended.
We would be delighted to help you prepare for Brexit with providing the following services:
Strategic advice and guidance
Planning the changes required across your Reg and PV organisations
Execution of the changes from generating the variations required to change the name and/or address of the MAH or manufacturing sites through to identifying and establishing a suitable EU based QPPV.
We attach short document which provides more detail regarding this service. We would welcome the opportunity to support you with your Brexit related impacts.