Medicines and Medical Devices Bill

Moved by

Baroness Thornton

3: Page 1, line 6, at end insert—

“( ) In making regulations under subsection (1), the appropriate authority must have regard to the desirability of—

(a) regulatory alignment with the European Medicines Agency’s medicines regulation;

(b) regulatory alignment with EU clinical trials regulations;

(c) recognition of and participation in the European Medicines Agency’s medicines licensing processes.”

Member’s explanatory statement

This amendment requires the appropriate authority to have regard to the desirability of regulatory alignment with EU regulations.