Regulation 7 Amendment to regulation 8I1

omit the definition of “advanced therapy medicinal product”;

in the definition of “Annex I to the 2001 Directive”^f1, after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”;

omit the definition of “Commission Regulation 2016/161”^f2;

in the definition of “conditional marketing authorisation”^f3, for “UKMA (GB)” substitute “UKMA(UK)(Category 1)”;

omit the definition of “healthcare institution”^f4;

in the definition of “marketing authorisation”, omit paragraph (b) and the “or” which precedes it;

in the definition of “name”, omit paragraph (b) (but not the “and” which follows it);

in the definition of “pharmacovigilance system”^f5, omit “, EU marketing authorisation”;

in the definition of “pharmacovigilance system master file”^f6, omit “, EU marketing authorisation”;

in the definition of “post-authorisation safety study”, omit “, EU marketing authorisation”;

omit the definition of “Regulation (EC) No 1394/2007”;

in the definition of “UK marketing authorisation”^f7, in paragraph (a), after “authorisation” insert “, within the definition of UKMA(UK)(Category 1) or UKMA(UK)(Category 2),”;

after the definition of “UK marketing authorisation”, insert—

• ““UKMA(UK)(Category 1)” means a marketing authorisation of the description in regulation 49(1ZB);

• “UKMA(UK)(Category 2)” means a marketing authorisation of the description in regulation 49(1ZC);”;

in the definition of “under the unfettered access route”, in paragraph (a), for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”;