SCHEDULES

F1SCHEDULE 3ASUPPLEMENTARY LICENCE CONDITIONS: HUMAN APPLICATION

Annotations:
Amendments (Textual)
F1

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)

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.

11B

1

The modifications to the second Directive are as follows.

2

Article 2 is to be read as if, in paragraph 1, the reference to Member States were a reference to the Authority.

3

Articles 3, 4 and 5 are to be read as if any reference to the competent authority or authorities were a reference to the Authority.

4

Annex 1 is to be read as if, in the first paragraph, for “responsible person as defined in Article 17 of Directive 2004/23/EC” there were substituted “ person responsible in accordance with section 17 of the Human Fertilisation and Embryology Act 1990 ”.

5

Annex 2 is to be read as if, in paragraph 2.1, the reference to the competent authority in the Member State were a reference to the Authority.

6

Annex 3 is to be read as if, in paragraph 3.6, for “in force in Member States” there were substituted “ of the Human Fertilisation and Embryology Act 1990 ”.

7

Annex 4 is to be read as if—

a

in paragraphs 1.1.1 and 1.2.1, the reference to an authorised person were to—

i

the person responsible in accordance with section 17 of this Act, or

ii

a person authorised by the person responsible or the Authority to carry out the specified tasks;

b

in paragraph 1.1.1(a), for “Article 13 of Directive 2004/23/EC” there were substituted “ the Human Fertilisation and Embryology Act 1990 ”;

c

in paragraph 1.4.4, the reference to the competent authority were a reference to the Authority.

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 ”.