delete Transitional provisions relating to EU Exit
This is the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, which amends the 2004 Regulations to reflect Brexit. Key changes include: replacing EEA/EU references with UK-specific provisions, creating 'approved country' lists for import and marketing authorization recognition, modifying qualified person requirements for manufacturing, amending adverse reaction reporting timeframes (7/15 days), and creating new import pathways for comparator products. The regulation grants the licensing authority discretion to publish and maintain lists of approved countries and requires 3-year periodic reviews of included countries.
This amendment creates new regulatory burdens post-Brexit that contradict the goal of restoring Britain's free-trading position. The 'approved country' list regime (regulations 2A, 43A) establishes discretionary bureaucratic approval processes that restrict import pathways and create regulatory uncertainty for pharmaceutical companies. The 3-year mandatory review cycle for country lists introduces ongoing compliance instability. While EU references were appropriately removed, they were replaced with complex new licensing authority discretion frameworks rather than genuine liberalisation. The regulation maintains prescriptive good manufacturing practice requirements that could be achieved through private certification and market mechanisms. Overall, this represents a missed opportunity to reduce regulatory burden on clinical trials and pharmaceutical imports.