Overview of medicines legislation and guidance

Safety, quality and efficacy are the only criteria on which legislation to control human medicines is founded. It is the responsibility of the MHRA and the expert advisory bodies set up by the Medicines Act to ensure that the balance between safety and effectiveness is achieved. The first comprehensive licensing system for medicines in the UK was the Medicines Act of 1968. The current relevant leglislation is given in European Directive 2001/83/EC (as amended) relating to medicinal products for human use. Although the European legislation takes precedence, there are regulations in the Medicines Act specific to the UK.

Preparing a medicinal product for sale in the UK or EU marketplace

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Overview of topics and issues related to preparing a medicinal product for the UK or EU marketplace.
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Inspection

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Overview of legislation and guidance related to inspections.
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Pharmacovigilance

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Overview of topics and issues related to pharmacovigilance.
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Project to consolidate and review UK medicines legislation

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This page details the project to consolidate and review UK medicines legislation.
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Glossary of legislation

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A glossary of legislation related to medicines in the UK and EU.
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Herbal and homoeopathic medicines

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Overview of topics and issues related to herbal and homeopathic medicines.

Importing and exporting

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Overview of topics and issues related to importing and exporting medicinal products.

Sunset Clause

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The so-called Sunset Clause refers to the statutory requirements to inform the Licensing Authority (the MHRA in the UK) of any disruptions to supply of medicines.

Review of EU medicines legislation ('2001 Review')

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In October 2001, the Commission published its proposals to amend the body of legislation covering the EU medicines regulatory regime (Regulation 2309/93 and Directives 2001/82/EC and 2001/83/EC). Following detailed negotiations between the Council of the European Union and the European Parliament, agreement on the proposed legislative amendments was reached in early 2004.
Page last modified: 13 October 2010