The Human Tissue (Quality and Safety for Human Application) Regulations 2007

Preconditions to grant of licence U.K.

11.—(1) The Authority may not grant a licence under Schedule 1 unless the following requirements are met.

(2) The proposed designated individual must—

(a) be the applicant for the licence, or

(b) consent to the application for the licence.

(3) The Authority must be satisfied that the proposed designated individual—

(a) is a suitable person to supervise the activity to be authorised by the licence,

(b) will perform the duty imposed by regulation 12,

(c) either—

(i) has a diploma, certificate or other evidence of formal qualification in the fields of medical or biological sciences awarded on completion of a university course of study, or other course of study recognised in the United Kingdom as equivalent, or

(ii) is otherwise considered by the Authority to be suitably qualified on the basis of academic qualifications and practical experience, and

(d) has at least two years' practical experience which is directly relevant to the activity to be authorised by the licence.

(4) Where the applicant for the licence is not the proposed designated individual, the Authority must be satisfied that the applicant is a suitable person to be the holder of the licence.

[F1 (4A) In the case of an application for a licence to make qualifying imports (which are not one-off imports), the Authority must be satisfied that—

(a) the applicant has taken any measures as may be specified by the Authority for the purposes of ensuring that any qualifying tissues or cells imported from a third country will meet standards of quality and safety equivalent to those laid down in these Regulations;

(b) the applicant has provided to the Authority, whether in connection with this application or a previous application—

(i) the information set out in Parts A to E of Annex I to the fourth Directive (information to be provided by importing tissue establishments);

(ii) the documents set out in Part F to Annex I to the fourth Directive (documentation to be provided by importing tissue establishments);

(c) the applicant has—

(i) made available for inspection by the Authority, whether in connection with this application or a previous application, any documents listed in Parts A and B of Annex III to the fourth Directive (availability and provision of documentation by importing tissue establishments); and

(ii) if requested by the Authority, provided any documents falling within paragraph (i) to the Authority;

(d) the applicant has entered into a written agreement with any proposed third country supplier;

(e) any written agreement mentioned in sub-paragraph (d) complies with the requirements of Article 7(2) and (3) of the fourth Directive (written agreements); and

(f) the applicant has provided the Authority with a copy of any written agreement mentioned in sub-paragraph (d).

(4B) In the case of an application for a licence to make qualifying imports which are one-off imports, the Authority must be satisfied that—

(a) the applicant has taken any measures as may be specified by the Authority for the purposes of ensuring that any qualifying tissues or cells imported from a third country will meet standards of quality and safety equivalent to those laid down in these Regulations;

(b) the applicant has provided to the Authority, whether in connection with this application or a previous application, the information set out in Parts A to E of Annex I to the fourth Directive (information to be provided by importing tissue establishments);

[F2 (c) in relation to Great Britain, the applicant has provided the Authority with any information or documents as may be specified by the Authority for the purposes of demonstrating—

(i) traceability; and

(ii) that the import is a one-off import within the meaning of paragraph (4C); and

(d) in relation to Northern Ireland, the applicant has provided the Authority with any information or documents as may be specified by the Authority for the purposes of securing compliance with the requirements of Articles 5(2) and 7(1) of the fourth Directive (requirements in relation to one off imports).]

(4C) In paragraphs (4A) and (4B)—

(a) a reference to a “one-off import” is a reference to an import of a specific type of tissues or cells, which will be for the personal use of an intended recipient who is known to the applicant and the third country supplier before the import occurs, and which, in relation to any given recipient, occurs only once, except where the proposed designated individual is satisfied that—

(i) the tissues or cells to be imported are of the same type as the tissues or cells previously imported and will be used for further treatment;

(ii) the quality and safety of any tissues or cells previously imported under paragraph (i) may not meet standards of quality and safety equivalent to those laid down in these Regulations and a further import is needed; or

(iii) it is desirable for those tissues or cells to be imported on separate occasions in order to protect against the risk of loss or damage in transit;

(b) “qualifying import” means the import F3 ... from a third country of tissues or cells intended for human application;

“qualifying tissues or cells” means tissues or cells intended for human application.]

(5) The Authority must be satisfied that—

(a) any premises in respect of which the licence is to be granted, and

(b) any premises which are proposed to be relevant third party premises in relation to the licence to be granted,

are suitable for the activity to be authorised by the licence.

(6) A copy of the conditions to be imposed by the licence must have been shown to, and acknowledged in writing by—

(a) the applicant for the licence, and

(b) where different, the proposed designated individual.

(7) In this regulation, references to the proposed designated individual are to the individual whom the application proposes that the licence should designate as the person under whose supervision the activity to be authorised by the licence is to be carried on.

Textual Amendments

F1 Reg. 11(4A)-(4C) inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 3(4)

F2 Reg. 11(4B)(c)(d) substituted by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(9)(a) (as substituted by S.I. 2020/1306, regs. 1, 12); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 11(4C)(b) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(9)(b) (as substituted by S.I. 2020/1306, regs. 1, 12); 2020 c. 1, Sch. 5 para. 1(1)

Modifications etc. (not altering text)

C1 Reg. 11(4A)-(4C) restricted (temp.) (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 4 (as amended by S.I. 2020/1306, regs. 1, 26); 2020 c. 1, Sch. 5 para. 1(1)