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

Type Statutory-Instrument

Publication 2007-05-24

Last updated 2024-03-21

State In force

Department King's Printer of Acts of Parliament

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(c) the observation of any activity relevant to ascertaining whether qualifying tissues or cells imported from a third country meet standards of quality and safety equivalent to those laid down in these Regulations.

(8) In this regulation—

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

“relevant documents” mean documents relevant for the purposes of ascertaining whether qualifying tissues or cells imported from a third country meet standards of quality and safety equivalent to those laid down in these Regulations;

“requesting authority” has the meaning given in paragraph (1)(c).

Third country premises and third country suppliers: report of inspections etc , Northern Ireland

20C

(1) This regulation applies in relation to Northern Ireland where the European Commission or a competent authority in an EEA state... requests the Authority to provide it with—

(a) a copy of a report or information on any inspection of third country premises or relevant documents carried out in pursuance of regulation 20B(2) or (4);

(b) information on any exercise of the Authority’s powers under paragraph 7(2), 8(3) or 9(1) of Schedule 3 to the 2004 Act (licences for the purposes of section 16) in relation to a licence held by an importing licence holder (whether in pursuance of regulation 20B(2) or otherwise); or

(2) The Authority must provide the report or information in question to the person requesting it, unless the Authority considers that it would be inappropriate to do so in the particular circumstances of the case.

Inspection of documents to be held by an importing licence holder , Northern Ireland

21A

(1) This regulation applies where—

(a) qualifying tissues or cells are imported into Northern Ireland from a third country by an importing licence holder;

(b) the tissues or cells are then distributed or will be distributed in an EEA state...; and

(c) the competent authority in that state ... requests the Authority to arrange for an inspection to be carried out of any relevant documents held by an importing licence holder.

(2) The Authority must arrange for an inspection to be carried out by a duly authorised person, unless the Authority considers that it would be inappropriate in the particular circumstances of the case.

(3) A duly authorised person may require a person to produce for inspection any relevant documents.

(4) Where relevant documents are stored in electronic form, a duly authorised person may require an importing licence holder to make the documents available for inspection—

(a) in a visible and legible form; or

(b) in a form from which they can readily be produced in a visible and legible form.

(5) A duly authorised person may take copies of any relevant documents inspected in pursuance of a requirement under this regulation.

(6) In this regulation—

“duly authorised person” in the context of any provision, means a person authorised by the Authority to act for the purposes of that provision;

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

“relevant documents” means a document relevant for the purposes of ascertaining whether tissues or cells imported from a third country meet standards of quality and safety equivalent to those laid down in these Regulations.

Entry and inspection of premises

Importing licence holders: requests for inspections , Northern Ireland

22A

(1) This regulation applies where—

(a) any licensed activity in relation to qualifying tissues or cells imported into Northern Ireland from a third country is carried out on any premises—

(i) to which a licence held by an importing licence holder relates; or

(ii) which are relevant third party premises in relation to an importing licence holder;

(b) the tissues or cells are distributed in an EEA state...; and

(c) the competent authority in that state ... requests the Authority to arrange for an inspection of the premises to be carried out.

(2) The Authority must arrange for an inspection of the premises in question to be carried out under regulation 22(1) by a duly authorised person, unless the Authority considers that it would be inappropriate to do so in the particular circumstances of the case.

(3) Before an inspection is carried out under paragraph (2), the Authority must make arrangements with the requesting authority for it to participate in the inspection, unless the Authority considers that the participation of the requesting authority is not appropriate in the circumstances.

(4) Where the Authority considers that the participation of the requesting authority in the inspection would not be appropriate in the circumstances, the Authority must notify the requesting authority of its decision and give reasons for that decision.

(5) In this regulation—

“duly authorised person” in the context of any provision, means a person authorised by the Authority to act for the purposes of that provision;

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

“requesting authority” means the competent authority which made the request under paragraph (1) for the Authority to arrange for the inspection to be carried out.

Entry and search in connection with suspected offence

Execution of warrants

Seizure in the course of inspection or search

Powers: supplementary

Requirements when exercising power of inspection or search

Enforcement

Meaning of duly authorised person

5A

Where the Authority grants a licence under this Schedule authorising the carrying on of the activities to which regulation 7(1A) applies, it must provide the designated individual in relation to that licence with a certificate—

(a) of authority in relation to Great Britain, in such form as the Authority considers appropriate,

(b) in relation to Northern Ireland, in the form set out in Annex II to the fourth Directive.

1A

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.

4A

Directions must require that importing licence holders are required to—

(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).

Updated information

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 ... 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).

Written agreements

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).

Modifications to the first, second, third and fourth Directives: general

4A

For the purposes of these Regulations, as they apply in relation to Great Britain, the first, second, third and fourth Directives are to be read subject to the modifications set out in regulations 4B to 4E.

Modifications to the first Directive

4B

(1) The modifications to the first Directive are as follows.

(2) Article 8 is to be read as if—

(a) in paragraph 1, the reference to Member States were a reference to the Authority;

(b) in paragraph 1, for “on their territory” there were substituted “in Great Britain”;

(3) Article 10(1) is to be read as if—

(a) for the reference to “the requirements referred to in Article 28(f)” there were substituted “ the requirements referred to in paragraph 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b) the reference to the competent authority or authorities were a reference to the Authority;

(d) the words “This report shall be publicly accessible” were omitted.

(4) 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 Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b) in paragraph 2, for “they” there were substituted “the Authority”;

(i) the first reference to Member States were a reference to the Authority;

(ii) “in Member States” were omitted.

(5) Article 15 is to be read as if paragraphs 1, 2 and 4 were omitted.

(6) Article 19(5) is to be read as if the words “, in accordance with Article 8” were omitted.

(7) 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 of the third Directive listed in paragraph 14 of Schedule 2 to these Regulations.

(8) Article 21 is to be read as if—

(a) in paragraph 4, for “laid down in this Directive” there were substituted “ of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(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 the Human Tissue Act 2004, the Human Tissue (Scotland) Act 2006 or these Regulations;

(iii) for the words “Member States' legislation” there were substituted “ legislation ”.

(9) 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 Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b) in paragraph 5, the reference to the competent authority or authorities were a reference to the Authority.

(10) The Annex is to be read as if—

(a) in paragraph B.1, for “the legislation in force in Member States” there were substituted “ the requirements of the Human Tissue Act 2004, the Human Tissue (Scotland) Act 2006 or the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b) paragraph B.2 were omitted.

Modifications to the second Directive

4C

(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 “ designated individual in accordance with regulations 11 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(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 Tissue (Quality and Safety for Human Application) Regulations 2007 ”.

(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 designated individual in accordance with regulations 11 and 12 of these Regulations, or

(ii) a person authorised to carry out the specified tasks by—

(aa) the designated individual, or

(bb) the Authority;

(b) in paragraph 1.1.1(a), for “Article 13 of Directive 2004/23/EC” there were substituted “ the Human Tissue Act 2004, the Human Tissue (Scotland) Act 2006 or the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

Modifications to the third Directive

4D

(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 “ designated individual ”;

(ii) for “as provided in Article 17 of Directive 2004/23/EC there were substituted “ in accordance with the requirements of regulations 11 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b) in paragraph A.4, for “laid down in this Directive” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(c) in paragraph C.6, for the words from “the requirements of Council” to the end there were substituted “ the 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 Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(e) in paragraph E.1, for “laid down in this Directive” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(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 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 are met ”;

(c) in paragraph B.3, for the words from “the standards” to the end there were substituted “ the requirements of paragraph 13 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(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 paragraph 14 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(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 designated individual in accordance with regulations 11 and 12 of these Regulations;

(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 4 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”.

Modifications to the fourth Directive

4E

(1) The modifications to the fourth Directive are as follows.

(2) The Directive is to be read as if references to a third country were references to any country other than the United Kingdom.

(3) Article 2 is to be read as if for “the Union”, in each place where it occurs, there were substituted “Great Britain”.

(4) Article 5(1) is to be read as if—

(a) for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b) the references to the competent authority or authorities were references to the Authority.

(5) Article 6 is to be read as if—

(za) in paragraph 1, the reference to the competent authority or authorities were a reference to the Authority;

(a) in paragraph 2—

(i) the reference to the competent authority or authorities were a reference to the Authority;

(ii) the words from “The information laid out” to the end were omitted;

(b) in paragraph 3—

(i) the first reference to the competent authority or authorities were a reference to the Authority;

(ii) the reference to the competent authority or authorities in subparagraph (b) were a reference to the authority in the third country concerned responsible for regulating tissue establishments in that country.

(6) Article 7 is to be read as if—

(a) in paragraph 1—

(i) in the first subparagraph, for “the Union”, in each place where it occurs, there were substituted “Great Britain”;

(ii) for the second subparagraph, there were substituted “ This requirement does not apply to one-off imports as defined in regulation 11(4C)(a) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 provided that the requirements in regulation 11(4B) of those regulations are met. ”;

(b) in paragraph 2, for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(d) in paragraph 4, the reference to the competent authority or authorities were a reference to the Authority.

(7) Article 8(1) is to be read as if the word “annual” were omitted.

(8) Annex 1 is to be read as if—

(a) in paragraph A.4, for “TE compendium code” there were substituted “ reference number previously allocated to the tissue establishment by the Authority ”;

(b) in paragraph B.4, the reference to the Responsible Person were a reference to the designated individual in accordance with regulations 11 and 12 of these Regulations;

(d) in paragraph F.3, the references to a third country competent authority or authorities were references to the authority in the third country responsible for regulating tissue establishments in that country.

(9) Annex 3 is to be read as if—

(a) in the first paragraph, the reference to the competent authority or authorities were a reference to the Authority;

(b) in paragraph A.1, for “as laid down in Directive 2004/23/EC” there were substituted “ in accordance with regulations 11 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(d) in paragraph B.7, the reference to a third country competent authority or authorities were a reference to the authority in the third country responsible for regulating tissue establishments in that country.

(10) Annex 4 is to be read as if—

(a) in paragraph 1, for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b) in paragraph 4, the reference to a third country competent authority or authorities were a reference to the authority in the third country responsible for regulating tissue establishments in that country;

(d) in paragraph 7, for “EU data protection rules” there were substituted “ data protection legislation within the meaning of section 3(9) of the Data Protection Act 2018 ”;

(e) in paragraph 8, for the words from “requirements” to the end there were substituted “ quality and safety standards required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”.

Interpretation of other terms

References to third party agreements etc

Import into Northern Ireland from the EEA

Directions: Great Britain

Directions: compliance with first, second, third and fourth Directives as they apply in relation to Northern Ireland

16A

(1) In relation to Northern Ireland, the Authority shall give directions to licence holders or designated individuals under section 23(1) of the 2004 Act, as applied by regulation 8, in accordance with Schedule 2 for the purpose of securing compliance with the requirements of the first, second, third and fourth Directives.

(2) In relation to Northern Ireland, the Authority shall give such other directions to licence holders or designated individuals under section 23(1) of that Act, as applied by regulation 8, as it considers necessary for securing compliance by licence holders and third parties with any requirements of the first, second, third and fourth Directives.

Powers to make regulations in relation to standards of quality and safety, Great Britain

34ZA

(1) The appropriate authority may by regulations make provision specifying requirements to be met for the purposes of ensuring traceability.

(2) The appropriate authority may by regulations make provision in relation to the notification of serious adverse events and reactions (whether to the Authority or such other person as may be specified in the regulations).

(3) The appropriate authority may by regulations make provision specifying requirements to be met for the purposes of verifying that standards of quality and safety equivalent to those required by these Regulations apply in relation to imports by tissue establishments of tissues and cells from third countries.

(4) The appropriate authority may by regulations prescribe technical requirements in relation to the following—

(i) the licensing or authorisation of tissue establishments;

(ii) the procurement of tissues or cells;

(iii) selection criteria for the donor of tissues or cells;

(iv) laboratory tests required for donors;

(v) procedures for the reception of tissues and cells at the tissue establishment;

(vi) the tissue and cell preparation process;

(vii) tissue and cell processing, storage and distribution;

(viii) the direct distribution to the recipient of specific tissues and cells.

(5) The provision that may be made in regulations under paragraphs (1) to (4) includes provision amending regulations 4A to 4E to modify, or further modify, the provisions of the second, third and fourth Directives as they apply by virtue of these Regulations.

(6) In this regulation “appropriate authority” means—

(a) in relation to England, the Secretary of State;

(b) in relation to Wales—

(i) the Welsh Ministers; or

(ii) the Secretary of State acting with the consent of the Welsh Ministers;

(i) the Scottish Ministers; or

(ii) the Secretary of State acting with the consent of the Scottish Ministers;

(d) for the whole of Great Britain, the Secretary of State acting with the consent of the Welsh Ministers and the Scottish Ministers.

Scope and nature of powers

34ZB

(1) Regulations made by the Secretary of State or the Welsh Ministers under regulation 34ZA are to be made by statutory instrument.

(2) For regulations made under regulation 34ZA by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments).

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) Any power in regulation 34ZA to make regulations includes a power to make—

(a) different provision for different purposes;

(b) consequential, supplementary, incidental, transitional, transitory or saving provision.

Scrutiny of regulations

34ZC

(1) A statutory instrument containing regulations made by the Secretary of State under regulation 34ZA may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament.

(2) A statutory instrument containing regulations made by the Welsh Ministers may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, the National Assembly for Wales.

(3) Regulations made by the Scottish Ministers under regulation 34ZA are subject to the affirmative procedure (see section 29 of the Interpretation and Legislative Reform (Scotland) Act 2010).

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Offences by bodies corporate

Transitional arrangements: storage licences

1ZA

In relation to Northern Ireland, directions shall require that licence holders adopt such systems as the Authority considers appropriate to secure—

(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).

4ZA

In relation to Northern Ireland, 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,

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.

7A

In relation to Northern Ireland, 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 the requirements of Article 5 (notification of serious adverse reactions) and Article 6 (notification of serious adverse events) of the third Directive.

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