Does my product need a licence?

Before a medicine can be placed on the UK market it must have a licence (marketing authorisation) already granted, setting out its agreed terms and conditions of use such as indications and dosage. Obviously there are products where it is not easy to distinguish a medicine from, for example, cosmetics or food supplements. This section helps describe how a medicine is defined and how the Agency deals with such products that appear to fall within this borderline.

The MHRA also allows for certain exemptions from licensing. This section also outlines three of the more significant exemptions i.e. the manufacture and supply of medicines for individual patients (‘specials’); the import and supply of medicines for individual patients; and exemptions for herbal remedies.


Page last modified: 07 September 2005