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

Explanatory Note

(This note is not part of the Regulations)

These Regulations make amendments to: the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (“the Standard Provisions Regulations”), which amongst other matters set the standard conditions for licences to manufacture or distribute by way of wholesale dealing medicinal products in the United Kingdom and which implement in part Titles IV and VII of Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use(1); and the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the Marketing Authorisations Regulations”), which relate to the scheme for authorising the marketing of medicinal products for human use in the United Kingdom and which implement various provisions of Directive 2001/83/EC, as amended.

Regulation 2 amends the Standard Provisions Regulations. A new requirement is imposed on holders of manufacturer’s licences to keep detailed records in relation to intermediate products used in the manufacture of biological medicinal products for human use. Holders of manufacturer’s and wholesale dealer’s licences are also required to take all reasonable precautions and exercise all due diligence to ensure that any information they provide to the licensing authority which is relevant to the evaluation of the safety, quality and efficacy of medicinal products for human use that they manufacture or deal in is not false or misleading in a material particular. Manufacturers are also required to take all reasonable precautions and exercise all due diligence to ensure that the information they provide about starting materials and intermediate products used in the manufacture of medicinal products for human use is not false or misleading in a material particular. Paragraphs (2) and (4)(a) correct minor errors arising from the Medicines (Codification Amendment Etc.) Regulations 2002, which updated the references in United Kingdom legislation to certain European Community instruments relating to medicinal products for human use to take account of the adoption of Directive 2001/83/EC.

Regulation 3 amends the Marketing Authorisations Regulations. It creates new criminal offences for failures to provide information relevant to the evaluation of safety, quality or efficacy of a medicinal product for human use and for the provision of information to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of medicinal products for human use but which is false or misleading in a material particular. These offences relate to obligations under Directive 2001/83/EC; in particular the obligation on applicants for authorisation to provide all information relevant to an evaluation of a product’s safety, quality and efficacy (see Article 8 and the introduction to Annex I of Directive 2001/83/EC) and to keep this information up to date (Articles 23, 24 and 106(6)) and the obligation on competent authorities to evaluate products' safety, quality and efficacy both on receipt of an application for authorisation and during the currency of a marketing authorisation (see Articles 19, 21, 24, 26, 107 and 116).

A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

(1)

OJ No. L 311 28.11.2001, p.67.