# Human Fertilisation and Embryology Act 1990, Paragraph 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 ”.

---
Source: https://www.legislation.gov.uk/ukpga/1990/37/schedule/3A/paragraph/11C (the official version)
Page: https://openlegislation.uk/human-fertilisation-and-embryology-act-1990/schedule-3A/paragraph-11C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.