Paragraph 6 I1

In regulation 20 (amendment of regulation 45 (suspension and revocation of manufacturing authorisation)), for “omit “or any equivalent provisions in any EEA State other than the United Kingdom”.” substitute “for “or any equivalent provisions in any EEA State other than the United Kingdom” substitute “ or, in the case of an investigational medicinal product manufactured or assembled in Northern Ireland, any equivalent provisions in any EEA State ”.”.