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)

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.