Overview of medicines legislation and guidance: Glossary of legislation

European legislation

• Council Directive 2001/83/EC (external link) on the Community code relating to medicinal products for human use as amended by Directive 2004/27/EC (external link) and Directive 2004/24/EC (external link) and Directive 2002/98/EC (external link)

This legislation regulates the licensing, manufacture of and wholesale dealing in medicinal products within the European Community.

• Council Directive 2003/94/EC (external link) laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products

This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacture requires an authorisation.

Primary (UK) Legislation

• Medicines Act 1968 as amended (external link)

This Act regulates, in part, the manufacture, distribution and importation of medicinal products.

Secondary Legislation (UK Statutory Instruments)

• The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005 No. 2789) (external link)

Replaces, as respects medicinal products to which the relevant EU legislation applies ('relevant medicinal products'), the existing regulations which implement the Directive 2001/83/EC, as amended. Sets out the obligations with which holders of manufacturer’s and wholesale dealer’s licenses must comply in respect of those licences.

The Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971 (SI 1971 No. 974), as amended.

These Regulations relate to applications for the grant of Manufacturer’s and Wholesale Dealer’s Licences other than licences of right. They prescribe the form and manner in which such applications are to be made, and specify the information that shall accompany each application.

• Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977 (SI 1977 No. 1038), as amended (external link)

These Regulations relate to prescribed conditions for manufacturer’s undertakings for imported products.

• Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (SI 1994 No. 3144), as amended (external link)

They provide the functions for the Competent Authority of a member State under the relevant Community provisions Directive 2001/83/EC as amended by 2004/27/EC are, except as otherwise provided, to be performed in the UK by the Licensing Authority.

They also provide that no medicinal product for human use which is subject to the relevant Community provisions may be placed on the market or distributed in the UK other than in accordance with a current marketing authorisation granted by the Licensing Authority or the European Commission.

• The Medicines (Products for Human Use – Fees) Regulations 1995 (SI 1995 No. 1116), as amended (external link)

These Regulations make provision for the fees payable under the Medicines Act 1971 in respect of marketing authorisations, licences and certificates relating to medicinal products for human use.

• The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004 No. 1031) as amended (external link)

These Regulations implement Directive 2001/20/EC on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

The Unlicensed Medicinal Products for Human Use (Transmissible Sponigform Encephalopathies) (Safety) Regulations 2003 (SI 2003 No. 1680) (external link)

Regulates the importation and marketing of unlicensed medicinal products for human use in order to minimise the risk of the transmission of Transmissible Spongiform Encephalopathies via those products.

Prescription Only Medicines (Human Use) Order 1997 (as amended) (SI 1997 No. 1830), as amended (external link)

This order specifies the descriptions and classes of prescription only medicines.