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

Regulation 16

F1 SCHEDULE 2 U.K. [F2 Directions for securing compliance with the first, second, third and fourth Directives]

Textual Amendments

F1 Sch. 2 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(b)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Sch. 2 heading substituted (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), 8(1)(a)

Traceability and coding system U.K.

[F3 1.   In relation to Great Britain, directions shall require that licence holders adopt such systems as the Authority considers appropriate to secure, in relation to traceability, compliance with the requirements of Article 8 of the first Directive (traceability) and Article 9 of the third Directive (traceability).] U.K.

Textual Amendments

F3 Sch. 2 para. 1 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(a) (as amended by S.I. 2020/1306, regs. 1, 25(a)); 2020 c. 1, Sch. 5 para. 1(1)

[F4 1ZA.   In relation to Northern Ireland, directions shall require that licence holders adopt such systems as the Authority considers appropriate to secure— U.K.

(a) in relation to traceability, compliance with the requirements of Article 8 (traceability) of the first Directive and Article 9 (traceability) of the third Directive, and

(b) in relation to the coding of information, compliance with—

(i) the requirements of paragraph 1 of Article 25 of the first Directive (coding of information);

(ii) the requirements of paragraph 1 of Article 10 of the third Directive (European coding system), subject to any exemption specified in the directions in accordance with paragraph 3 of that Article;

(iii) the requirements of Article 10a of the third Directive (format of the Single European Code); and

(iv) the requirements of paragraph 1(a) to (f) and (h) of Article 10b of the third Directive (requirements related to the application of the Single European Code).]

Textual Amendments

F4 Sch. 2 para. 1ZA inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(aa) (as inserted by S.I. 2020/1306, regs. 1, 25(b)); 2020 c. 1, Sch. 5 para. 1(1)

[F5 1A.   [F6 In relation to Northern Ireland, directions] must require information that the Authority considers appropriate to secure compliance with the requirements of paragraph 1(g) of Article 10b of the third Directive to be provided to the Authority.]

Textual Amendments

F5 Sch. 2 para. 1A 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), 8(1)(c) (with reg. 10)

F6 Words in Sch. 2 para. 1A substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(b) (as substituted by S.I. 2020/1306, regs. 1, 25(c)); 2020 c. 1, Sch. 5 para. 1(1)

[F7 2.   Directions given for the purposes of paragraph 1(a) must include directions requiring designated individuals to ensure that third parties responsible for human application retain the information listed in Annex VI to the third Directive (minimum data to be kept in accordance with Article 9(2).]

Textual Amendments

F7 Sch. 2 para. 2 substituted (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), 8(1)(d)

Reporting obligations U.K.

3.  Directions under paragraph 2(4)(c) to (e) of Schedule 3 to the 2004 Act (as applied by regulation 8) shall specify the information to be recorded, the form in which it is to be recorded, the period for which such information is to be kept and the persons to whom any specified information is to be provided for the purpose of securing compliance with the requirements of Article 10(1) (register of tissue establishments and reporting obligations) of the first Directive [F8 and Article 8(1) (register of importing tissue establishments) of the fourth Directive]. U.K.

Textual Amendments

F8 Words in Sch. 2 para. 3 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), 8(1)(e)

Serious adverse events and serious adverse reactions U.K.

4.   [F9 In relation to Great Britain, directions shall] require licence holders to adopt such—

(a) systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and

(b) accurate, rapid and verifiable procedures for recalling from distribution any product which may be related to a serious adverse event or serious adverse reaction,

[F10 as the Authority considers appropriate].

Textual Amendments

F9 Words in Sch. 2 para. 4 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(c)(i) (as substituted by S.I. 2020/1306, regs. 1, 25(d)); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Sch. 2 para. 4 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(c)(ii) (as substituted by S.I. 2020/1306, regs. 1, 25(d)); 2020 c. 1, Sch. 5 para. 1(1)

[F11 4ZA.   In relation to Northern Ireland, directions shall require licence holders to adopt such— U.K.

(a) systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and

(b) accurate, rapid and verifiable procedures for recalling from distribution any product which may be related to a serious adverse event or serious adverse reaction,

as are necessary to secure compliance with the requirements of Article 11 (notification of serious adverse events and reactions) of the first Directive and Article 5 (notification of serious adverse reactions) and Article 6 (notification of serious adverse events) of the third Directive.]

Textual Amendments

F11 Sch. 2 para. 4ZA inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(ca) (as inserted by S.I. 2020/1306, regs. 1, 25(e)); 2020 c. 1, Sch. 5 para. 1(1)

[F12 4A.   Directions must require that importing licence holders are required to— U.K.

(a) notify the Authority of any serious adverse events or serious adverse reactions notified to the importing licence holder by that person’s third country supplier (including events or reactions which that supplier suspects are serious adverse events or reactions); and

(b) provide any information specified in the direction which the Authority requires for the purposes of securing compliance with the requirements of Article 6(2) of the fourth Directive (updated information).]

Textual Amendments

F12 Sch. 2 para. 4A 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), 8(1)(f)

Third party agreements and termination of licensed activities U.K.

5.  For the purpose of securing compliance with the requirements of Article 21(5) (tissue and cell storage conditions) and Article 24 (relations between tissue establishments and third parties) of the first Directive, directions shall specify the requirements that must be met in relation to the termination of storage activities authorised by the licence and in relation to third party agreements. U.K.

Procurement and use of tissue or cells U.K.

6.  Directions shall specify the requirements to be met by all licence holders authorised to procure tissue or cells to secure compliance with the requirements (including as to staff training, written agreements with staff, standard operating procedures, and appropriate facilities and equipment) laid down in Article 2 (requirements for the procurement of human tissues and cells) of the second Directive. U.K.

7.   [F13 In relation to Great Britain, directions shall] be given—

(a) for the purpose of securing that procurement organisations comply with the requirements of the Annex to the first Directive (information to be provided on the donation of tissue or cells), and

(b) for the purpose of securing that procurement organisations and organisations responsible for human application of tissue or cells comply with [F14 the requirements of these Regulations in relation to notification of serious adverse reactions and notification of serious adverse events.]

Textual Amendments

F13 Words in Sch. 2 para. 7 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(d)(i) (as substituted by S.I. 2020/1306, regs. 1, 25(f)); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in Sch. 2 para. 7(b) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(d)(ii) (as substituted by S.I. 2020/1306, regs. 1, 25(f)); 2020 c. 1, Sch. 5 para. 1(1)

[F15 7A.   In relation to Northern Ireland, directions shall be given— U.K.

(a) for the purpose of securing that procurement organisations comply with the requirements of the Annex to the first Directive (information to be provided on the donation of tissue or cells), and

(b) for the purpose of securing that procurement organisations and organisations responsible for human application of tissue or cells comply with the requirements of Article 5 (notification of serious adverse reactions) and Article 6 (notification of serious adverse events) of the third Directive.]

Textual Amendments

F15 Sch. 2 para. 7A inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(e) (as inserted by S.I. 2020/1306, regs. 1, 25(g)); 2020 c. 1, Sch. 5 para. 1(1)

8.  In giving directions for the purposes of paragraph 7, the Authority shall, in particular, impose a requirement on designated individuals to ensure that records are retained, and the Authority and tissue establishments are notified without delay, of any serious adverse event and any serious adverse reaction. U.K.

Selection criteria and laboratory tests required for donors of tissues and cells U.K.

9.  In relation to donors of tissues or cells who are deceased at the time of donation, directions shall impose requirements in respect of the selection criteria for such donors, in accordance with— U.K.

(a) in relation to all such donors, point 1.1 (general criteria for exclusion), and

(b) in relation to such donors who are children, point 1.2 (additional exclusion criteria for deceased child donors),

of Annex I (selection criteria for donors of tissue or cells) to the second Directive.

10.  In relation to donors of tissues or cells who are alive at the time of donation, directions shall impose requirements in respect of the selection criteria for such donors, in accordance with— U.K.

(a) in relation to autologous donors, point 2.1 (autologous living donor),

(b) in relation to allogeneic donors, point 2.2 (allogeneic living donor),

of Annex I to the second Directive.

11.  Directions shall, in respect of all donors of tissues or cells, deal with the biological tests to be performed and carried out, in accordance with the requirements of section 1 (biological tests required for donors) and section 2 (general requirements to be met for determining biological markers) of Annex II (laboratory tests required for donors) to the second Directive. U.K.

Donation and procurement procedures and reception at the tissue establishment U.K.

12.  In respect of— U.K.

(a) donation and procurement procedures, and

(b) the reception of tissue and cells at premises specified in a licence under Schedule 1,

directions shall be given for the purpose of securing compliance with the requirements of Article 15(3) (selection, evaluation and procurement) and Article 19(4) to (6) (tissue and cell reception) of the first Directive and with the requirements laid down in the provisions of the second Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions.

	Relevant provisions of the second Directive
1. Donation and procurement procedures
Consent and donor identification (record of consent, method of identification, donor interview)	Annex IV, point 1.1
Donor evaluation: other than autologous donors (assessment of donor's medical and behavioural information and physical examinations)	Annex IV, point 1.2
Procurement procedures for tissue and cells (requirements relating to procurement procedures and instruments)	Annex IV, point 1.3
Donor documentation (record of donor and the procurement)	Annex IV, point 1.4
Packaging (requirements as to packaging and shipping containers)	Annex IV, point 1.5
Labelling of the procured tissue and cells (minimum labelling requirements)	Annex IV, point 1.6
Labelling of the shipping container (minimum labelling requirements)	Annex IV, point 1.7
2. Reception of tissue and cells at the tissue establishment
Verification upon arrival (procedures for verification and requirement for quarantine until verification)	Annex IV, point 2.1 to 2.3
Registration of data	Annex IV, point 2.4

Requirements for holding a licence under Schedule 1 U.K.

13.  Directions shall be given for the purpose of securing compliance with the requirements laid down in the provisions of the third Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions. U.K.

	Relevant provisions of the third Directive
Organisation and management (requirements as to organisational structure, management systems, and third party agreements)	Annex I, Part A
Personnel (number, competence, responsibilities and training)	Annex I, Part B
Equipment and materials (appropriate for use, validation, maintenance, and specifications)	Annex I, Part C
Facilities and premises (suitability, environment, storage, and maintenance)	Annex I, Part D
Documentation and records (standard operating procedures, document control, record reliability)	Annex I, Part E
Quality review (quality management system, investigations, corrective action, and reviews)	Annex I, Part F

Requirements for holding a licence under Schedule 1 for tissue and cell preparation processes U.K.

14.  In respect of tissue and cell preparation processes, directions shall be given for the purpose of securing compliance with— U.K.

(a) the requirements of Article 20(2) and (3) (tissue and cell processing) and Article 21(2) to (4) of the first Directive, and

(b) the requirements laid down in the provisions of the third Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions.

	Relevant provisions of the third Directive
Reception of tissue and cells at the tissue establishment	Annex II, Part A
Processing of tissue and cells (validation, documentation and evaluation of critical procedures)	Annex II, Part B
Storage and release of tissue and cells (criteria to be complied with, including standard operating procedure)	Annex II, Part C
Distribution and recall of tissue and cells (criteria to be complied with, including procedures to be adopted)	Annex II, Part D
Final labelling of tissue and cells containers for distribution (information to be shown on container label or in accompanying documentation)	Annex II, Part E
External labelling of the shipping container (information to be shown on label on shipping container)	Annex II, Part F

[F16 Updated information U.K.

15.— (1) Directions must require that importing licence holders must not make any substantial changes in connection with any qualifying import made by that licence holder unless the requirement in sub-paragraph (2) or (3) is met.

(2) The requirement of this sub-paragraph is where the substantial change would require the variation of a condition of the licence authorising the qualifying import—

(a) the importing licence holder has made an application to the Authority to vary the licence under paragraph 8(2) of Schedule 3 to the 2004 Act, as applied by regulation 8, to reflect the change; and

(b) the Authority has made that variation.

(3) The requirement in this sub-paragraph is where the substantial change does not fall within sub-paragraph (2), the Authority has approved the change in writing.

(4) Directions must require that importing licence holders must notify the Authority—

(a) if the licence holder ceases to make qualifying imports; and

(b) of any changes in circumstances of the importing licence holder’s third country supplier of which the importing licence holder is aware.

(5) In this paragraph—

“changes of circumstances” means any changes in circumstances of the description specified in the direction in question in accordance with the provision made in Article 6(3) of the fourth Directive (notification of revocation of third country’s authorisation);

“qualifying import” means the import F17 ... from a third country of tissues or cells intended for human application;

“qualifying tissues or cells” means tissues or cells intended for human application; and

“substantial changes” means changes of the description specified in the direction in question in accordance with the provision as to the meaning of substantial changes made in Article 3(3) of the fourth Directive (requirements where substantial changes made to import activities).]

Textual Amendments

F16 Sch. 2 paras. 15, 16 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), 8(1)(g)

F17 Words in Sch. 2 para. 15(5) 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(21)(f) (as inserted by S.I. 2020/1306, regs. 1, 25(g)); 2020 c. 1, Sch. 5 para. 1(1); 2020 c. 1, Sch. 5 para. 1(1)

[F16 Written agreements U.K.

16.   Directions must specify the requirements to be made by all importing licence holders to secure compliance with the requirements of Article 7 of the fourth Directive (written agreements).]

Textual Amendments

F16 Sch. 2 paras. 15, 16 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), 8(1)(g)