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 regulatory provisions in place in the UK for unlicensed medicinal products have been in place for a number of years. Given the developments that have taken place over the years there is now a clear case for reviewing those provisions.

On 28 February 2008, the Agency issued an informal consultation document which sought the views of stakeholders on the possible reform of those regulatory arrangements. Responses were invited by 30 June 2008.

Informal consultation meetings with a range of stakeholder groups have recently taken place. Following this period of informal consultation and exploration of the issues, we envisage it is likely that a formal consultation exercise will then take place setting out specific proposals for reform of the current arrangements. The MHRA’s website will be updated to reflect progress.

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