The legal classification of a medicine in the UK refers to the three legal categories, POM, P and GSL, which determine the level of control of its supply. Sometimes this classification might change by a procedure called ‘reclassification’ or ‘switching’. This can be led by stakeholder groups, industry or healthcare professionals and result from a growing confidence of the medicine’s role and improved understanding of its side effects.
Within Regulink, we have this niche experience via our core team, who have undertaken numerous such reclassifications in the UK, both for major and standard applications for POM to P and P to GSL switches.
The underlying principle for classifying medicines is to maximise timely access to effective medicines while minimising the risk of harm from inappropriate use.
Reclassification applications require good supporting evidence focussing on the public health risk by the change to the control over its supply. This might comprise clinical studies, acceptable side effect profile, advice and opinions of experts, health professionals professional bodies, public associations and interested individuals. In order to demonstrate that the risk to the public will be adequately managed, measures such as restricting/varying dosage, pack size, duration of use, indications, categories of patient would be considered.
MHRA Scientific Advice is advised. The MHRA might consult its expert external committees, ‘stakeholder groups’ comprising health professionals and representatives of people affected by the classification change and run a public consultation.
The procedure can be significant for major and standard reclassifications. Simple “me-too” applications for analogous products can be handled by variation applications. All reclassifications require an existing or pending UK Marketing Authorisation.
