The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 inserted these requirements into the Clinical Trials regulations. This guidance provides the lists of countries and a summary of the circumstances under which the lists can be used. These lists will be reviewed at least every three (3) years, beginning from 1 January 2021.
These countries are include EU countries such as Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
The European Economic Area (EEA) countries and EU countries, plus Iceland, Liechtenstein and Norway.
There is no requirement to confirm QP certification in respect of products obtained from a Northern Ireland wholesaler or manufacturer. Compatriot products should be obtained via the relevant regulatory route for that product.
Source: MHRA guideline on List of approved countries for clinical trials and investigational medicinal products from 1 January 2021