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Medicinal products: a new reclassification process in the UK

United Kingdom
20/05/2002
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The Medicines Control Agency has announced a new reclassification process by which medicines are reclassified from doctors’ or dentists’ prescription only (POM) to available in a pharmacy without prescription under the supervision of a pharmacist (P) or from (P) to general sales list (GSL). From 1 April 2002 the legal status of a medicinal product becomes part of the marketing authorisation (rather than determined by the listed active substance). A change in legal status will be conferred on the product, that is the subject of the switching application. This brings the UK into line with most other countries and is consistent with Directive 2001/83 EC.

The practical effect of this change is that new fully supported applications for switching would have to be made in respect of all other products with the same active substance in order for them to follow suit. Thus, there is a (limited) opportunity for a competitive advantage for the first reclassified product of a minimum of 90 days, whilst any subsequent application for reclassification of any competitor product is assessed.

For further information please contact Zelda Pickup on +44(0)20 7367 2043 or by e-mail at [email protected]

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