The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
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Change 1
7 Amendment to regulation 8
In regulation 8 (general interpretation)— (a) in paragraph (1)— (i) omit the definition of “advanced therapy medicinal product”; (ii) in the definition of “Annex I to the 2001 Directive”, after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”; (iii) omit the definition of “Commission Regulation 2016/161”; (iv) in the definition of “conditional marketing authorisation”, for “UKMA (GB)” substitute “UKMA(UK)(Category 1)”; (v) omit the definition of “healthcare institution”; (vi) in the definition of “marketing authorisation”, omit paragraph (b) and the “or” which precedes it; (vii) in the definition of “name”, omit paragraph (b) (but not the “and” which follows it); (viii) in the definition of “pharmacovigilance system”, omit “, EU marketing authorisation”; (ix) in the definition of “pharmacovigilance system master file”, omit “, EU marketing authorisation”; (x) in the definition of “post-authorisation safety study”, omit “, EU marketing authorisation”; (xi) omit the definition of “Regulation (EC) No 1394/2007”; (xii) in the definition of “UK marketing authorisation”, in paragraph (a), after “authorisation” insert “, within the definition of UKMA(UK)(Category 1) or UKMA(UK)(Category 2),”; (xiii) 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); ; (xiv) in the definition of “under the unfettered access route”, in paragraph (a), for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”; (b) in paragraph (9), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
7 Amendment to regulation 8
In regulation 8 (general interpretation)— (a) in paragraph (1)— (i) omit the definition of “advanced therapy medicinal product”; (ii) in the definition of “Annex I to the 2001 Directive”, after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”; (iii) omit the definition of “Commission Regulation 2016/161”; (iv) in the definition of “conditional marketing authorisation”, for “UKMA (GB)” substitute “UKMA(UK)(Category 1)”; (v) omit the definition of “healthcare institution”; (vi) in the definition of “marketing authorisation”, omit paragraph (b) and the “or” which precedes it; (vii) in the definition of “name”, omit paragraph (b) (but not the “and” which follows it); (viii) in the definition of “pharmacovigilance system”, omit “, EU marketing authorisation”; (ix) in the definition of “pharmacovigilance system master file”, omit “, EU marketing authorisation”; (x) in the definition of “post-authorisation safety study”, omit “, EU marketing authorisation”; (xi) omit the definition of “Regulation (EC) No 1394/2007”; (xii) in the definition of “UK marketing authorisation”, in paragraph (a), after “authorisation” insert “, within the definition of UKMA(UK)(Category 1) or UKMA(UK)(Category 2),”; (xiii) 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); ; (xiv) in the definition of “under the unfettered access route”, in paragraph (a), for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”; (b) in paragraph (9), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
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