Review of unlicensed medicines

In May 2009, the MHRA published an interim report (380Kb), the second consultative document issued under the review and outlines progress made. The package of consultation documents can be accessed from the website. The report built on the document which was issued in February 2008 and sought feedback on emerging ideas for reform, including specific information on the impact of an option that is under consideration for a possible structure for reformed regulatory arrangements.

The consultation closed in September 2009. Further engagement with stakeholders is planned in the months ahead to outline the progress that has been made since the consultation closed.

Background
Under European medicines legislation (Directive 2001/83/EC), a medicinal product placed on the market is required to have a marketing authorisation granted following demonstration of safety, quality and efficacy. However, under Article 5 (1) of Directive 2001/83, Member States are permitted to put in place national arrangements to apply allowing an authorised healthcare professional to commission the manufacture of an unlicensed medicinal product to meet the special needs of an individual patient under his direct personal responsibility. The UK has made use of this derogation to establish national provisions. There are arrangements in place for “Specials” manufactured in the UK and a notification scheme for products imported in to the UK.

Further information about those current arrangements is available via the following links:

Medicines that do not need a licence (Exemptions from licensing)

Importing unlicensed medicines