SCHEDULES
F1SCHEDULE 3ASUPPLEMENTARY LICENCE CONDITIONS: HUMAN APPLICATION
F2Modifications to the first, second and third Directives
Sch. 3A paras. 11A-11C and cross-heading inserted (31.12.2020) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/482), regs. 1, 2(17)(c) (with reg. 4) (as amended by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 16(c)); 2020 c. 1, Sch. 5 para. 1(1)
11A
1
The modifications to the first Directive are as follows.
2
Article 8 is to be read as if—
a
in paragraph 1—
i
the reference to Member States were a reference to the Authority;
ii
for “on their territory” there were substituted “in Great Britain”
;
b
paragraphs 2, 3 5 and 6 were omitted.
3
Article 14 is to be read as if—
a
in paragraph 1—
i
the reference to Member States were a reference to the Authority;
ii
for “within the scope of this Directive” there were substituted “
in accordance with the Human Fertilisation and Embryology Act 1990
”
;
b
in paragraph 2, the reference to Member States were a reference to the Authority;
c
in paragraph 3—
i
the first reference to Member States were a reference to the Authority;
ii
“in Member States” were omitted.
4
Article 15 is to be read as if paragraphs 1, 2 and 4 were omitted.
5
Article 19(5) is to be read as if the words “in accordance with Article 8” were omitted.
6
Article 20 is to be read as if in paragraph 1, the reference to Article 28(h) were a reference to the requirements of Annex 2 to the third Directive listed in paragraph 11 of this Schedule.
7
Article 21 is to be read as if—
a
in paragraph 4, for “laid down in this Directive” there were substituted “
of the Human Fertilisation and Embryology Act 1990
”
;
b
in paragraph 5—
i
the first reference to Member States were a reference to the Authority;
ii
the reference to a tissue establishment accredited, designated, authorised or licensed in accordance with Article 6 were a reference to a tissue establishment authorised or licensed in accordance with the provisions of this Act;
iii
for the words “Member States' legislation” there were substituted “
legislation
”
.
8
Article 24 is to be read as if—
a
in paragraph 2, for “laid down in this Directive” there were substituted “
required by the Human Fertilisation and Embryology Act 1990
”
;
b
in paragraph 5, the reference to the competent authority or authorities were a reference to the Authority.
9
The Annex is to be read as if—
a
in paragraph B.1, for “legislation in force in Member States” there were substituted “
requirements of Schedule 3 to the Human Fertilisation and Embryology Act 1990
”
;
b
paragraph B.2 were omitted.
Sch. 3A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs 1, 30