Review of unlicensed medicines

The MHRA is currently reviewing the regulatory arrangements that exist in the UK which allow an authorised healthcare professional to commission an unlicensed medicinal product to meet the special needs of an individual patient. The review was established in late 2007 and there have been two informal consultation documents published under the review. The first was in 2008:

 Informal consultation paper on the review of the regulation of unlicensed medicines (2008)

and the second in 2009:

 Informal consultation paper on the review of unlicensed medicines (2009)

Since the interim report was published under the review in 2009, there has been further dialogue with a range of interested parties in 2010 and in March 2011. A copy of the presentation which was delivered at meetings with a range of interested parties in March 2011 is below:

 MHRA presentation on the review of unlicensed medicines (March 2011) Powerpoint file (opens in new window) (658Kb)

The MHRA is currently carrying out some further work on assessing the impact of possible proposals on the sector. We would hope to be able to provide more information on the timetable for progressing the review in the near future.

This section of the website will be updated to reflect progress under the review.

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. Under Article 5 (1) of Directive 2001/83, Member States are permitted to put in place national arrangements to allow an authorised healthcare professional to commission the manufacture of an unlicensed medicinal product to meet the special needs of an individual patient under their direct personal responsibility.

The UK has made use of this derogation to establish national provisions. There are currently arrangements in place for unlicensed medicines manufactured in the UK and a notification scheme for medicines imported into the UK. Those national provisions are set out in the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, as amended and the Medicines for Human Use (manufacturing, wholesale dealing and miscellaneous amendments) Regulations 2005.

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


Page last modified: 25 January 2012