SCHEDULES

SCHEDULE 1Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

I13

For regulation 17 (amendment of regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products)) substitute—

17

In regulation 36(2), after “marketing authorization” insert “ or marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC ”.