Legalize / United Kingdom / Statutory-Instrument

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Type Statutory-Instrument

Publication 2010-07-21

Last updated 2012-08-14

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

PDF Download

articles Not indexed

Reform history JSON API

Made: 21st July 2010

Laid before Parliament: 26th July 2010

Coming into force: 19th August 2010

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Citation, commencement and interpretation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Disapplication of section 7 of the Medicines Act 1968 to exempt advanced therapy medicinal products

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Licence conditions for exempt advanced therapy medicinal products

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Traceability

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Traceability in the event of bankruptcy or liquidation of holder of manufacturer's licence for exempt ATMP

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of the Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Regulations 1971

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 1 — Requirement that holders of manufacturer's licences comply with certain obligations in relation to the manufacture and assembly of exempt advanced therapy medicinal products

A holder of a manufacturer’s licence must—

(a) comply with the principles and guidelines of good manufacturing practice;

(b) maintain such staff, premises, equipment and facilities—

(i) as are necessary for such stages of the manufacture and assembly of exempt advanced therapy medicinal products as are undertaken by the manufacturer’s licence holder in accordance with the requirements of the manufacturer’s licence, and

(ii) for the handling, control, storage and distribution of the exempt advanced therapy medicinal products which are handled, stored and distributed under the licence, as are necessary to maintain the quality of those products;

(i) before making any material alteration to the premises or facilities used under the manufacturer’s licence, or in the operations for which they are used,

(ii) of any change that manufacturer’s licence holder proposes to make to any personnel named in the licence as responsible for quality control of the exempt advanced therapy medicinal products being manufactured or assembled by the manufacturer’s licence holder, and

(iii) of any adverse reaction or suspected adverse reaction of which the holder is aware within 15 days of becoming aware of it;

(d) for the purpose of enabling the licensing authority to ascertain whether there are any grounds—

(i) for suspending, revoking or varying any licence granted under Part II of the Act, or

(ii) suspending or terminating any licence in accordance with the provisions of Part II of the Act,

permit, and provide all necessary facilities to enable, any person duly authorised in writing by the licensing authority, on production if required of the relevant credentials, to carry out such inspection or to take such samples or copies, in relation to things belonging to, or any business carried on by, the holder of the licence, as such person would have the right to carry out or take under the Act for the purpose of verifying any statement contained in an application for a licence;

(e) ensure that any arrangements that are made with any person for the control, storage and distribution of the exempt advanced therapy medicinal products are adequate to maintain the quality of those products;

(f) not carry out any manufacture or assembly of exempt advanced therapy medicinal products other than—

(i) the manufacture or assembly of those classes of exempt advanced therapy medicinal product specified in the licence, and

(ii) at the premises specified in the licence;

(g) not use any premises for the handling, control, storage or distribution of exempt advanced therapy medicinal products other than those specified in the manufacturer’s licence as approved by the licensing authority for that purpose, or approved by the licensing authority for that purpose from time to time;

(h) if using human cells or tissues in an exempt advanced therapy medicinal product, ensure that the donation, procurement and testing of those cells or tissues is in accordance with Directive 2004/23/EC[^f00024];

(i) ensure that any human tissue or cell component imported into the United Kingdom and used by the manufacturer’s licence holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product shall meet equivalent standards of quality and safety to those laid down in Commission Directives 2006/17/EC[^f00025] and 2006/86/EC[^f00026];

(j) ensure that any blood or blood component imported into the United Kingdom and used by the manufacturer’s licence holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product shall meet equivalent standards of quality and safety to those laid down in Commission Directive 2004/33/EC[^f00027], implementing Directive 2002/98/EC[^f00028] of the European Parliament and of the Council as regards certain technical requirements for blood and blood components;

(k) where the holder of a manufacturer’s licence distributes by way of wholesale dealing any exempt advanced therapy medicinal product manufactured or assembled pursuant to the licence, comply with the requirements of sub-paragraphs (e), (k), (o) and (p) of Schedule 3 as if that person were the holder of a wholesale dealer’s licence;

(l) not solicit any order for an exempt advanced therapy medicinal product by—

(i) advertising or making any representation relating to an exempt advanced therapy medicinal product with a view to the advertisement or representation being seen generally by the public in the United Kingdom,

(ii) advertising an exempt advanced therapy medicinal product by means of any catalogue or circular letter,

or otherwise;

(m) at the written request of the licensing authority set up a risk management system designed to identify, characterise, prevent or minimise risks related to the exempt advanced therapy medicinal product;

(n) establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivered to the establishment where the product is used;

(o) subject to paragraph 1(j) of Schedule 2, keep the data referred to in sub-paragraph (n) for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product;

(p) secure that the data referred to in sub-paragraph (n) will, in the event that—

(i) the licence is suspended, revoked or withdrawn, or

(ii) the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a manufacturer’s licence for the period described in sub-paragraph (o) or such longer period as may be required pursuant to paragraph 1(j) of Schedule 2;

(q) where an exempt advanced therapy medicinal product contains human cells or tissues, ensure that the traceability system established in accordance with subparagraph (n) is complementary to and compatible with the requirements laid down in Articles 8 and 14 of Directive 2004/23/EC[^f00029] as regards human cells and tissues other than blood cells, and Articles 14 and 24 of Directive 2002/98/EC as regards human blood cells; and

(r) not import or export any exempt advanced therapy medicinal product.

SCHEDULE 2 — Standard provisions for manufacturer's licences insofar as those licences relate to exempt advanced therapy medicinal products

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 3 — Requirement that holders of wholesale dealer's licences comply with certain obligations in relation to exempt advanced therapy medicinal products

The holder of a wholesale dealer’s licence, must—

(a) at all times have at that person’s disposal the services of a person (referred to in this Schedule as “a responsible person”) who—

(i) in the opinion of the licensing authority—

(aa) has knowledge of the activities to be carried out and of the procedures to be performed under the licence which is adequate for performing the functions of responsible person, and

(bb) has experience in those procedures and activities which is adequate for those purposes, and

(ii) is responsible for ensuring, in relation to exempt advanced therapy medicinal products, compliance with the conditions of the wholesale dealer’s licence;

(b) notify the licensing authority of—

(i) the name and address and degrees, diplomas or qualifications and experience of the person who will carry out the functions of responsible person,

(ii) any change of responsible person;

(c) subject to sub-paragraph (d), not permit any person to act as responsible person other than the person named in the licence as responsible person or, any other such person whose name is notified to the licensing authority in accordance with sub-paragraph (b)(ii);

(d) not permit a person to act as a responsible person where the licence holder has been notified in writing by the licensing authority that it is of the opinion that—

(i) the person so acting does not satisfy the provisions of sub-paragraph (a) as respects qualifications and experience, or

(ii) that person is failing to carry out the duties referred to in sub-paragraph (b) adequately or at all,

provided that the licensing authority has given the licence holder and the person acting as a responsible person the opportunity of making representations to them (orally or in writing) beforehand;

(e) comply with the guidelines on good distribution practice;

(f) provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the exempt advanced therapy medicinal products which are handled, stored or distributed under the licence as are necessary to maintain the quality of, and ensure proper distribution of, the exempt advanced therapy medicinal products which are handled, stored or distributed pursuant to the licence;

(g) inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or premises which have been approved from time to time by the licensing authority;

(h) for the purpose of enabling the licensing authority to ascertain whether there are any grounds—

(i) for suspending, revoking or varying any licence granted under Part II of the Act, or

(ii) for suspending or terminating any licence in accordance with the provisions of Part II of the Act,

permit and provide all necessary facilities to enable any person duly authorised in writing by the licensing authority, on production if required of the relevant credentials, to carry out such inspection or to take such samples or copies, in relation to things belonging to, or any business carried on by, the holder of the licence, as such person would have the right to carry out or take under the Act for the purpose of verifying any statement contained in an application for a licence;

(i) obtain supplies of exempt advance therapy medicinal products only from a—

(i) manufacturer’s licence holder, or

(ii) wholesale dealer’s licence holder,

in respect of such products;

(j) distribute an exempt advanced therapy medicinal product by way of wholesale dealing only to—

(i) a holder of a wholesale dealer’s licence relating to those products; or

(ii) a person who—

(aa) may lawfully administer those products, and

(bb) solicited the product for an individual patient;

(k) establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the establishment where the product is used;

(l) keep such records containing the following information in relation to exempt advanced therapy medicinal products which are received or dispatched by the holder of the wholesale dealer’s licence—

(i) the date of receipt or, as the case may be, dispatch,

(ii) the name of the products,

(iii) the quantity of the product received or, as the case may be, dispatched, and

(iv) the name and address of, as may be applicable in each case, the person from whom the products are received or to whom they are sold or supplied;

(m) have in place a plan for recalling, in cooperation with the manufacturer, any advanced therapy medicinal product where such recall is ordered by the licensing authority;

(n) inform the licensing authority of any adverse reaction to any exempt advanced therapy medicinal product supplied by the holder of the wholesale dealer’s licence of which the holder is aware;

(o) subject to sub-paragraph (d) of Schedule 4, keep the data referred to in sub-paragraph (k) for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product;

(p) secure that the data referred to in sub-paragraph (k) will, in the event that—

(i) the licence is suspended, revoked or withdrawn, or

(ii) the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a wholesale dealer’s licence for the period described in sub-paragraph (o) or such longer period as may be required pursuant to sub-paragraph (d) of Schedule 4;

(q) not import or export any exempt advanced therapy medicinal product; and

(r) not solicit any order for an exempt advanced therapy medicinal product by—

(i) advertising or making any representation relating to an exempt advanced therapy medicinal product with a view to the advertisement or representation being seen generally by the public in the United Kingdom,

(ii) advertising an exempt advanced therapy medicinal product by means of any catalogue or circular letter, or

(iii) any other means.

SCHEDULE 4 — Standard provisions for wholesale dealer's licences insofar as those licences relate to exempt advanced therapy medicinal products

The standard provisions, for the purposes of Part II of the Act, for wholesale dealer’s licences insofar as they relate to exempt advanced therapy medicinal products are—

(a) the licence holder shall not use any premises for the purpose of the handling, storage or distribution of exempt advanced therapy medicinal products other than those specified in the licence holder’s licence or notified to the licensing authority by the licence holder from time to time and approved by the licensing authority;

(b) the licence holder shall provide such information as may be requested by the licensing authority concerning the type and quantity of any exempt advanced therapy medicinal product which the licence holder handles, stores or distributes;

(c) the licence holder shall take all reasonable precautions and exercise all due diligence to ensure that any information the holder provides to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of any exempt advanced therapy medicinal product which the holder handles, stores or distributes is not false or misleading in a material particular; and

(d) the licence holder shall keep the data referred to in sub-paragraph (k) of Schedule 3 for such period, being a period of longer than 30 years, as may be specified by the licensing authority.

SCHEDULE 5 — Amendments to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Amendment of regulation 1

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 1

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 3

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 6

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Signed

Signed by authority of the Secretary of State for Health.

Earl Howe — Parliamentary Under-Secretary of State, — 21st July 2010

Andrew McCormick — Permanent Secretary, — Department of Health, Social Services and Public Safety — 21st July 2010

Explanatory note

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Footnotes

[^f00001]: Section 8(2D) was inserted by S.I. 2005/2789. See section 132(1) for the definition of “prescribed”.

[^f00002]: Section 8(3E) was inserted by S.I. 2005/2789.

[^f00003]: 1968 c.67. The expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations, is defined in section 1 of the Medicines Act 1968 as amended by paragraph 1(1) of the Schedule to S.I. 1999/3142 and paragraph 2 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00004]: By virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Department for which the Minister is responsible was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1.).

[^f00005]: S.I. 1972/1811.

[^f00006]: 1972 c.68. Section 2(2) was amended by the Legislative and Regulatory Reform Act 2006, section 27(1)(a).

[^f00007]: 1968 c.67.

[^f00008]: OJ No. L 324, 10.12.07, p.121.

[^f00009]: OJ No. L 311, 28.11.2001, p.67; relevant amending instruments are Directive 2002/98/EC of the European Parliament and of the Council (OJ No. L 33, 8.2.2003, p.30), Commission Directive 2003/63/EC (OJ No. L 159, 27.6.2003, p.46), Directive 2004/24/EC of the European Parliament and of the Council (OJ No. L 136, 30.4.2004, p.85), Directive 2004/27/EC of the European Parliament and of the Council (OJ No. L 136, 30.4.2004, p.34), Regulation (EC) No. 1901/2006 of the European Parliament and of the Council (OJ No. L 378, 27.12.2006, p.1), Regulation (EC) No. 1394/2007 of the European Parliament and of the Council (OJ No. L 324, 10.12.2007, p.121), Directive 2008/29/EC of the European Parliament and of the Council (OJ No. L 81, 20.3.2008, p.51), Directive 2009/53/EC of the European Parliament and of the Council (OJ No. L 168, 30.6.2009, p.33) and Commission Directive 2009/120/EC (OJ No. L 242, 15.9.2009, p.3).

[^f00010]: OJ No. L 262, 14.10.2003.

[^f00011]: Section 7 was amended by S.I.1977/1050, 1983/1724, 1992/604, 1994/276, 2004/1031, 2005/50, 2005/2753 and 2006/2407.

[^f00012]: OJ No. L 102, 7.4.2004, p.48.

[^f00013]: OJ No. L 33, 8.2.2003, p.30.

[^f00014]: Paragraph 13C is inserted by paragraph 3(4) of Schedule 5 to these Regulations.

[^f00015]: Paragraph 17 was inserted by S.I. 2005/1710 and amended by S.I. 2008/3097.

[^f00016]: S.I. 1994/3144.

[^f00017]: OJ No. L 136, 30.4.2004, p.1.

[^f00018]: S.I. 1971/972. Regulation 1A was inserted by S.I. 2005/2745 and revoked by S.I. 2005/2789 in relation to manufacturers’ licences and wholesale dealers’ licences insofar as such licences relate to relevant medicinal products as defined in S.I. 2005/2789.

[^f00019]: Relevant amending instruments are S.I. 2002/236, 2003/2321 and 2005/2789.

[^f00020]: S.I. 1971/974; relevant amending instruments are S.I. 1977/1052, 1978/1140, 1983/1725, 1993/832, 2002/236 and 2005/2789.

[^f00021]: S.I. 1994/3144.

[^f00022]: S.I. 2004/1031; relevant amending instruments are S.I. 2005/2754, 2006/1928 and 2008/941.

[^f00023]: S.I. 2005/2789.

[^f00024]: OJ No. L 102, 7.4.2004, p.48.

[^f00025]: OJ No. L 38, 9.2.2006, p.40.

[^f00026]: OJ No. L 294, 25.10.2006, p.32.

[^f00027]: OJ No. L 91, 30.3.2004, p.25.

[^f00028]: OJ No. L 33, 8.2.2003, p.30.

[^f00029]: OJ No. L 102, 7.4.2004, p.48.

[^f00030]: OJ No. L 262, 14.10.2003, p.22.

[^f00031]: S.I. 1971/974. There are no relevant amendments.

[^f00032]: The definition of “the 2001 Directive” was inserted by S.I. 2002/236 and amended by S.I. 2003/2321, 2004/3224, 2005/50, 2005/2759 and 2008/3097.

[^f00033]: The definition of “the Regulation (EC) No 726/2004” was inserted by S.I. 2004/3224 and amended by S.I. 2008/3097.

[^f00034]: The definition of “the relevant Community provisions” was substituted by S.I. 2002/236 and amended by S.I. 2003/2321, 2004/3224, 2005/2759 and 2008/3097.

[^f00035]: Paragraph 10A was inserted by S.I. 2005/1710.

[^f00036]: OJ No. L33, 8.2.2003, p.30.

[^f00037]: Paragraph 12 was amended by S.I. 1998/3105 and S.I. 2002/236.

[^f00038]: Paragraph 13B was inserted by S.I.2008/3097.

[^f00039]: Paragraph 15 was amended by S.I.2005/1710.

[^f00040]: OJ No. L204, 21.7.1998, p.37.

[^f00041]: OJ No. L217, 5.8.1998, p.18.

[^f00042]: OJ No L.363, 20.12.2006, p.81.

A holder of a manufacturer's licence must—

(a) comply with the principles and guidelines of good manufacturing practice;

(b) maintain such staff, premises, equipment and facilities—

(i) as are necessary for such stages of the manufacture and assembly of exempt advanced therapy medicinal products as are undertaken by the manufacturer's licence holder in accordance with the requirements of the manufacturer's licence, and

(ii) for the handling, control, storage and distribution of the exempt advanced therapy medicinal products which are handled, stored and distributed under the licence, as are necessary to maintain the quality of those products;

(i) before making any material alteration to the premises or facilities used under the manufacturer's licence, or in the operations for which they are used,

(ii) of any change that manufacturer's licence holder proposes to make to any personnel named in the licence as responsible for quality control of the exempt advanced therapy medicinal products being manufactured or assembled by the manufacturer's licence holder, and

(iii) of any adverse reaction or suspected adverse reaction of which the holder is aware within 15 days of becoming aware of it;

(d) for the purpose of enabling the licensing authority to ascertain whether there are any grounds—

(i) for suspending, revoking or varying any licence granted under Part II of the Act, or

(ii) suspending or terminating any licence in accordance with the provisions of Part II of the Act,

(e) ensure that any arrangements that are made with any person for the control, storage and distribution of the exempt advanced therapy medicinal products are adequate to maintain the quality of those products;

(f) not carry out any manufacture or assembly of exempt advanced therapy medicinal products other than—

(i) the manufacture or assembly of those classes of exempt advanced therapy medicinal product specified in the licence, and

(ii) at the premises specified in the licence;

(g) not use any premises for the handling, control, storage or distribution of exempt advanced therapy medicinal products other than those specified in the manufacturer's licence as approved by the licensing authority for that purpose, or approved by the licensing authority for that purpose from time to time;

(h) if using human cells or tissues in an exempt advanced therapy medicinal product, ensure that the donation, procurement and testing of those cells or tissues is in accordance with Directive 2004/23/EC ;

(i) ensure that any human tissue or cell component imported into the United Kingdom and used by the manufacturer's licence holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product shall meet equivalent standards of quality and safety to those laid down in Commission Directives 2006/17/EC and 2006/86/EC ;

(j) ensure that any blood or blood component imported into the United Kingdom and used by the manufacturer's licence holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product shall meet equivalent standards of quality and safety to those laid down in Commission Directive 2004/33/EC , implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components;

(k) where the holder of a manufacturer's licence distributes by way of wholesale dealing any exempt advanced therapy medicinal product manufactured or assembled pursuant to the licence, comply with the requirements of sub-paragraphs (e), (k), (o) and (p) of Schedule 3 as if that person were the holder of a wholesale dealer's licence;

(l) not solicit any order for an exempt advanced therapy medicinal product by—

(i) advertising or making any representation relating to an exempt advanced therapy medicinal product with a view to the advertisement or representation being seen generally by the public in the United Kingdom,

(ii) advertising an exempt advanced therapy medicinal product by means of any catalogue or circular letter,

or otherwise;

(m) at the written request of the licensing authority set up a risk management system designed to identify, characterise, prevent or minimise risks related to the exempt advanced therapy medicinal product;

(n) establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivered to the establishment where the product is used;

(o) subject to paragraph 1(j) of Schedule 2, keep the data referred to in sub-paragraph (n) for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product;

(p) secure that the data referred to in sub-paragraph (n) will, in the event that—

(i) the licence is suspended, revoked or withdrawn, or

(ii) the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a manufacturer's licence for the period described in sub-paragraph (o) or such longer period as may be required pursuant to paragraph 1(j) of Schedule 2;

(q) where an exempt advanced therapy medicinal product contains human cells or tissues, ensure that the traceability system established in accordance with subparagraph (n) is complementary to and compatible with the requirements laid down in Articles 8 and 14 of Directive 2004/23/EC as regards human cells and tissues other than blood cells, and Articles 14 and 24 of Directive 2002/98/EC as regards human blood cells; and

(r) not import or export any exempt advanced therapy medicinal product.

The holder of a wholesale dealer's licence, must—

(a) at all times have at that person's disposal the services of a person (referred to in this Schedule as “a responsible person”) who—

(i) in the opinion of the licensing authority—

(aa) has knowledge of the activities to be carried out and of the procedures to be performed under the licence which is adequate for performing the functions of responsible person, and

(bb) has experience in those procedures and activities which is adequate for those purposes, and

(ii) is responsible for ensuring, in relation to exempt advanced therapy medicinal products, compliance with the conditions of the wholesale dealer's licence;

(b) notify the licensing authority of—

(i) the name and address and degrees, diplomas or qualifications and experience of the person who will carry out the functions of responsible person,

(ii) any change of responsible person;

(c) subject to sub-paragraph (d), not permit any person to act as responsible person other than the person named in the licence as responsible person or, any other such person whose name is notified to the licensing authority in accordance with sub-paragraph (b)(ii);

(d) not permit a person to act as a responsible person where the licence holder has been notified in writing by the licensing authority that it is of the opinion that—

(i) the person so acting does not satisfy the provisions of sub-paragraph (a) as respects qualifications and experience, or

(ii) that person is failing to carry out the duties referred to in sub-paragraph (b) adequately or at all,

provided that the licensing authority has given the licence holder and the person acting as a responsible person the opportunity of making representations to them (orally or in writing) beforehand;

(e) comply with the guidelines on good distribution practice;

(f) provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the exempt advanced therapy medicinal products which are handled, stored or distributed under the licence as are necessary to maintain the quality of, and ensure proper distribution of, the exempt advanced therapy medicinal products which are handled, stored or distributed pursuant to the licence;

(g) inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or premises which have been approved from time to time by the licensing authority;

(h) for the purpose of enabling the licensing authority to ascertain whether there are any grounds—

(i) for suspending, revoking or varying any licence granted under Part II of the Act, or

(ii) for suspending or terminating any licence in accordance with the provisions of Part II of the Act,

(i) obtain supplies of exempt advance therapy medicinal products only from a—

(i) manufacturer's licence holder, or

(ii) wholesale dealer's licence holder,

in respect of such products;

(j) distribute an exempt advanced therapy medicinal product by way of wholesale dealing only to—

(i) a holder of a wholesale dealer's licence relating to those products; or

(ii) a person who—

(aa) may lawfully administer those products, and

(bb) solicited the product for an individual patient;

(k) establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the establishment where the product is used;

(l) keep such records containing the following information in relation to exempt advanced therapy medicinal products which are received or dispatched by the holder of the wholesale dealer's licence—

(i) the date of receipt or, as the case may be, dispatch,

(ii) the name of the products,

(iii) the quantity of the product received or, as the case may be, dispatched, and

(iv) the name and address of, as may be applicable in each case, the person from whom the products are received or to whom they are sold or supplied;

(m) have in place a plan for recalling, in cooperation with the manufacturer, any advanced therapy medicinal product where such recall is ordered by the licensing authority;

(n) inform the licensing authority of any adverse reaction to any exempt advanced therapy medicinal product supplied by the holder of the wholesale dealer's licence of which the holder is aware;

(o) subject to sub-paragraph (d) of Schedule 4, keep the data referred to in sub-paragraph (k) for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product;

(p) secure that the data referred to in sub-paragraph (k) will, in the event that—

(i) the licence is suspended, revoked or withdrawn, or

(ii) the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a wholesale dealer's licence for the period described in sub-paragraph (o) or such longer period as may be required pursuant to sub-paragraph (d) of Schedule 4;

(q) not import or export any exempt advanced therapy medicinal product; and

(r) not solicit any order for an exempt advanced therapy medicinal product by—

(i) advertising or making any representation relating to an exempt advanced therapy medicinal product with a view to the advertisement or representation being seen generally by the public in the United Kingdom,

(ii) advertising an exempt advanced therapy medicinal product by means of any catalogue or circular letter, or

(iii) any other means.

The standard provisions, for the purposes of Part II of the Act, for wholesale dealer's licences insofar as they relate to exempt advanced therapy medicinal products are—

(a) the licence holder shall not use any premises for the purpose of the handling, storage or distribution of exempt advanced therapy medicinal products other than those specified in the licence holder's licence or notified to the licensing authority by the licence holder from time to time and approved by the licensing authority;

(b) the licence holder shall provide such information as may be requested by the licensing authority concerning the type and quantity of any exempt advanced therapy medicinal product which the licence holder handles, stores or distributes;

(c) the licence holder shall take all reasonable precautions and exercise all due diligence to ensure that any information the holder provides to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of any exempt advanced therapy medicinal product which the holder handles, stores or distributes is not false or misleading in a material particular; and

(d) the licence holder shall keep the data referred to in sub-paragraph (k) of Schedule 3 for such period, being a period of longer than 30 years, as may be specified by the licensing authority.

Editorial notes

[^key-5d9cffc1aa67b929a12ce3d98f5c6179]: Regulations revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.