http://www.legislation.gov.uk/id/ukpga/1990/37/schedule/3A

SCHEDULES

F1SCHEDULE 3ASUPPLEMENTARY LICENCE CONDITIONS: HUMAN APPLICATION

Annotations:

Amendments (Textual)

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

F2Modifications to the first, second and third Directives

Annotations:

Amendments (Textual)

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)

11C

1

The modifications to the third Directive are as follows.

2

Annex 1 is to be read as if—

a

in paragraph A.1—

i

for “responsible person” there were substituted “ person responsible ”;

ii

for “as provided in Article 17 of Directive 2004/23/EC” there were substituted “ in accordance with the requirements of sections 16 and 17 of the Human Fertilisation and Embryology Act 1990 ”;

b

in paragraph A.4, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

c

in paragraph C.6, for the words from “requirements of Council” to the end there were substituted “ requirements of the Medical Devices Regulations 2002 ”;

d

in paragraph D.1, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

e

in paragraph E.1, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

f

in paragraph E.8, the reference to the competent authority were a reference to the Authority.

3

Annex 2 is to be read as if—

a

in the first paragraph, the reference to the competent authority were a reference to the Authority;

b

in paragraph A, for the words from “the tissues and cells must” to the end there were substituted “ tissue establishment procedures must ensure that the licence conditions in paragraph 9 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 are met ”;

c

in paragraph B.3, for the words from “the standards” to the end there were substituted “ the requirements of paragraph 10 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”;

d

in paragraph B.8, the second sentence were omitted;

e

in paragraph C.2, for “laid down in this Directive” there were substituted “ of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”;

f

in paragraphs C.4 and C.5, any reference to the responsible person as defined or specified in Article 17 of Directive 2004/23/EC were a reference to the person responsible in accordance with section 17 of this Act;

g

in paragraph D.5, the reference to the competent authority were a reference to the Authority;

h

in paragraph E.2(h), for “as set out in Articles 5 to 6” there were substituted “ in accordance with paragraph 3 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”.