Amendment to regulation 8
7. 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)”;
The definition was inserted by S.I. 2019/775 as amended by S.I. 2020/1488.
(iii) omit the definition of “Commission Regulation 2016/161”;
The definition was inserted by S.I. 2019/62 and S.R. 2019 No. 10.
(iv) in the definition of “conditional marketing authorisation”, for “UKMA (GB)” substitute “UKMA(UK)(Category 1)”;
The definition was inserted by S.I. 2019/775 as amended by S.I. 2020/1488.
(v) omit the definition of “healthcare institution”;
The definition was inserted by S.I. 2019/62 and S.R. 2019 No. 10.
(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”;
The definition was amended by S.I. 2019/775 as amended by S.I. 2020/1488.
(ix) in the definition of “pharmacovigilance system master file”, omit “, EU marketing authorisation”;
The definition was amended by S.I. 2019/775 as amended by S.I. 2020/1488.
(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),”;
The definition was substituted by S.I. 2019/775 as amended by S.I. 2020/1488.
(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)”.
Paragraph (9) was inserted by S.I. 2019/775 as amended by S.I. 2020/1488