SCHEDULES

SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 23Amendment of Schedule 8 (consequential provision)

194.

In Schedule 8 (consequential provision)—

(a)

in paragraph 4 (amendment of the Prescription Only Medicines (Human Use) Order 1997)—

(i)

for “In article 5(1)” substitute “ After article 5(1) ”; and

(ii)

for “insert “ UK ” before “marketing authorisation” ” substitute “insert—

“(1A)

In paragraph (1) “marketing authorisation” means—

(a)

in relation to medicinal products for sale or supply in Great Britain, a UKMA(GB) or UKMA(UK);

(b)

in relation to medicinal products for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK), an EU marketing authorisation or a parallel import licence.”;

(b)

in paragraph 8 (amendment of the Blood Safety and Quality Regulations 2005)—

(i)

for “as if reference” substitute “ as if the reference ”;

(ii)

after “within the meaning of” insert “ paragraph (a) of the definition of that term in ”;

(c)

for paragraph 7 (amendment of the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003) substitute—

“7.

In regulation 1(2) of the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 M1 (citation, commencement and interpretation), for the definition of “unlicensed product” substitute—

““unlicensed product” means—

(a)

in the case of a product to be imported or marketed in Great Britain, a medicinal product for human use, other than an excluded medicine, in respect of which no UKMA(GB), UKMA(UK), THR(UK) or THR(GB) has been granted;

(b)

in the case of a product to be imported or marketed in Northern Ireland, a medicinal product for human use, other than an excluded medicine, in respect of which no UKMA(NI), UKMA(UK), THR(UK) or THR(NI), EU marketing authorisation or Article 126a authorisation has been granted,

and “Article 126a authorisation”, “EU marketing authorisation”, “THR(GB)”, “THR(NI)”, “THR(UK)”, “UKMA(GB)”, “UKMA(NI)” and “UKMA(UK)” have the meanings given in regulation 8 of the 2012 Regulations;.;”.

(d)

in paragraph 16 (amendment of the Branded Health Service Medicines (Costs) Regulations 2018)—

(i)

omit sub-paragraph (2)(a) to (d);

(ii)

omit sub-paragraph (3);

(iii)

omit sub-paragraph (4)(a)(i);

(iv)

for sub-paragraph (4)(a)(ii) substitute—

“(ii)

in sub-paragraph (b), after “Article 21” insert “ or regulation 64(6) of the 2012 Regulations ”; and”;

(v)

omit sub-paragraph (4)(b);

(vi)

omit sub-paragraph (5);

(vii)

omit sub-paragraph (6).