The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005

© Crown Copyright 2005

Statutory Instruments printed from this website are printed under the superintendence and authority of the Controller of HMSO being the Queen's Printer of Acts of Parliament.

The legislation contained on this web site is subject to Crown Copyright protection. It may be reproduced free of charge provided that it is reproduced accurately and that the source and copyright status of the material is made evident to users.

It should be noted that the right to reproduce the text of Statutory Instruments does not extend to the Queen's Printer imprints which should be removed from any copies of the Statutory Instrument which are issued or made available to the public. This includes reproduction of the Statutory Instrument on the Internet and on intranet sites. The Royal Arms may be reproduced only where they are an integral part of the original document.

The text of this Internet version of the Statutory Instrument which is published by the Queen's Printer of Acts of Parliament has been prepared to reflect the text as it was Made. A print version is also available and is published by The Stationery Office Limited as the The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005, ISBN 0110730119. The print version may be purchased by clicking here. Braille copies of this Statutory Instrument can also be purchased at the same price as the print edition by contacting TSO Customer Services on 0870 600 5522 or e-mail: customer.services@tso.co.uk.

Further information about the publication of legislation on this website can be found by referring to the Frequently Asked Questions.

To ensure fast access over slow connections, large documents have been segmented into "chunks". Where you see a "continue" button at the bottom of the page of text, this indicates that there is another chunk of text available.

(a) after the definition of "BCG vaccine"[6] insert the following definitions—

" "biological medicinal product" means a product, the active substance of which is a biological substance;
"biological substance" means a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control;"; and

(b) after the definition of "imported proprietary product"[7] insert the following definition—

" "intermediate product" means a substance, other than a starting material, which—
(a) has been manufactured for use in the manufacture of medicinal products, and

(b) is intended for further processing by a manufacturer of such products;".

    (3) In Schedule 1 (standard provisions for product licences), in Part I, in paragraph 16[8] omit the words "as amended".

    (4) In Schedule 2 (standard provisions for manufacturer's licences)—

(a) after paragraph 8A[9] insert the following paragraph—

     " 8AA. The licence holder shall keep readily available for examination by a person authorised by the licensing authority durable records of the details of manufacture of any intermediate products held by him which are for use in the manufacture of biological medicinal products for human use, and these records shall—


(a) be in such form as to ensure that the licence holder has a comprehensive record of all matters that are relevant to an evaluation of the safety, quality and efficacy of any finished biological medicinal product for human use which he manufactures using those intermediate products; and

(b) not be destroyed without the consent of the licensing authority until the records of the details of manufacture of any finished medicinal products which were or may be manufactured using those intermediate products may, in accordance with paragraph 8 above, be destroyed.";



(b) in paragraph 8B[10], for "8 or 8A" substitute "8, 8A or 8AA"; and

(c) after paragraph 17[11] insert the following paragraph—

     " 18. The licence holder shall take all reasonable precautions and exercise all due diligence to ensure that any information he provides to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of—


(a) any medicinal product for human use which he manufactures; or

(b) any starting materials or intermediate products that he holds which are for use in the manufacture of medicinal products for human use,



is not false or misleading in a material particular.".

    (5) In Schedule 3 (standard provisions for wholesale dealer's licences)—

(a) in paragraph 7A(3)(a)[12], for "Articles 23 and 24 of the Second Council Directive" substitute "Articles 49 and 50 of the 2001 Directive[13]"; and

(b) after paragraph 9[14] insert the following paragraph—

     " 10. The licence holder shall take all reasonable precautions and exercise all due diligence to ensure that any information he provides to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of any medicinal product for human use which he handles, stores or distributes is not false or misleading in a material particular.".

Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
     3. In Schedule 3 of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994[15] (offences, penalties etc.)—

(a) after paragraph 10 insert the following paragraph—

     " 10A. —(1) Any person who in the course of an application for the grant, renewal or variation of a marketing authorization for a relevant medicinal product—


(a) fails to provide to the licensing authority any information which is relevant to an evaluation of the safety, quality or efficacy of the relevant medicinal product as required by point (7) or (11) of the introduction to Annex I to the 2001 Directive[16]; or

(b) provides to the licensing authority any information which is relevant to an evaluation of the safety, quality or efficacy of the relevant medicinal product but which is false or misleading in a material particular,



shall be guilty of an offence.

    (2) Any person who—



(a) is responsible for placing a relevant medicinal product on the market;

(b) is the marketing authorization holder for a relevant medicinal product; or

(c) while employed or engaged as an appropriately qualified person responsible for pharmacovigilance for the purposes of Chapter 3 of Title II of Council Regulation (EEC) No 2309/93[17] or Title IX of the 2001 Directive is required to provide information to the licensing authority about a relevant medicinal product,



who provides to the licensing authority any information which is relevant to an evaluation of the safety, quality or efficacy of the relevant medicinal product but which is false or misleading in a material particular shall be guilty of an offence.";

(b) after paragraph 13 insert the following paragraph—

     " 13A. Any person who—


(a) sells or supplies a relevant medicinal product in accordance with any of paragraphs 1 to 4 of Schedule 1; or

(b) provides a specification for such a product for the purposes of paragraph 1 of that Schedule,



who provides to the licensing authority any information which is relevant to an evaluation of the safety, quality or efficacy of the relevant medicinal product but which is false or misleading in a material particular shall be guilty of an offence.";

(c) in paragraph 15, for "8, 9 or 10" substitute "8, 9, 10 or 10A"; and

(d) after paragraph 16 insert the following paragraph—

     " 17. —(1) A person does not commit an offence under paragraph 10A or 13A if he took all reasonable precautions and exercised all due diligence to avoid the commission of that offence.

    (2) Where evidence is adduced which is sufficient to raise an issue with respect to that defence, the court or jury shall assume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.".

Signed by authority of the Secretary of State for Health


Jane Kennedy
Minister of State, Department of Health

22 June 2005



Sealed with the Official Seal of the Department of Health, Social Services and Public Safety


D G Gowdy
Permanent Secretary, Department of Health, Social Services and Public Safety

23 June 2005



Sealed with the Official Seal of the Department of Agriculture and Rural Development


Pat Toal
Permanent Secretary, Department of Agriculture and Rural Development

24 June 2005

[2] S.I. 1972/1811.back

[3] 1968 c.67.back

[4] In the case of the Secretary of State, by virtue of articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142, and articles 3(7) of and 5(2) of, and the Schedule to, S.I. 2002/794; and in the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47) may now be exercised by the Departments by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c.1). The Departments were re-named by virtue of Article 3(4) and (6) of S.I. 1999/283 (N.I.1).back

[5] S.I. 1971/972; relevant amendments were made by S.I. 1977/1053, 1983/1730, 1992/2846, 1993/833, 1994/103, 2002/236 and 2003/2321.back

[6] The definition of "BCG vaccine" was inserted by regulation 2 of S.I. 1977/675.back

[7] The definition of "imported proprietary product" was inserted by regulation 2 of S.I. 1977/1053.back

[8] Inserted by S.I. 1993/2539 and amended by S.I. 2002/236 and 2003/2321.back

[9] Inserted by S.I. 1992/2846.back

[10] Inserted by S.I. 1992/2846.back

[11] Inserted by S.I. 1983/1730.back

[12] Paragraph 7A was inserted by S.I. 1993/833 and amended by S.I. 2002/236.back

[13] OJ L311, 28.11.2001, p.67.back

[14] Inserted by S.I. 1983/1730.back

[15] S.I. 1994/3144; Schedule 3 has been amended by S.I. 1998/3105, 2000/292, 2002/236 and 2003/2321.back

[16] See the definition of "the 2001 Directive" in regulation 1(2); Annex I was substituted by Commission Directive 2003/63/EC (OJ L159, 27.6.2003, p.46).back

[17] OJ No. L214, 24.8.93, p.1.back

[18] OJ No. L 311 28.11.2001, p.67.back