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

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(1) (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(2); 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(3) 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.”.

(1)

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

(2)

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).

(3)

OJ No. L214, 24.8.93, p.1.