The CCMO recently published a post on her website where possible consequences of brexit per 30th March 2019 for clinical research with medicinal products are mentioned.
These consequence might be, for instance:
- A new import license may be needed when the production is located in the United Kingdom.
- A new QP (Qualified Person), located in the EU, need be appointed.
- The sponsor or his legal representative must reside within the EU instead of . Any change in location constitutes a substantial amendment.
- Stricter rules on the exchange of personal information to countries outside the EU, according to the GDPR, are applicable.
You can find the original post on http://www.ccmo.nl/nl/nieuwsarchief/mogelijke-gevolgen-brexit-voor-klinisch-onderzoek. (Only available in Dutch.)