Brexit and possible consequences for clinical research

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:

  1. A new import license may be needed when the production is located in the United Kingdom.
  2. A new QP (Qualified Person), located in the EU, need be appointed.
  3. The sponsor or his legal representative must reside within the EU instead of . Any change in location constitutes a substantial amendment.
  4. 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  (Only available in Dutch.)