UK: Consultation on New Medicines Reclassification Guide
Posted 06 July 2012 | By
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on a new draft guideline clarifying how a company can initiate the regulatory review process for a major new reclassification of a drug product. All medicines marketed in the UK are classified according to one of three categories:
(1) Prescription Only Medicines (POM) - available only on a prescription;
(2) Pharmacy (P) - available under the supervision of a pharmacist; and
(3) General Sale List (GSL) - available in general retail outlets such as supermarkets.
When first authorized, new medicines are usually classified as a Prescription Only Medicine (POM). If the drug is shown over time to be safe for use without a prescription, it can be reclassified as a Pharmacy (P) or General Sale List (GSL) product. Requests for change of legal classification of medicines and associated policy matters are dealt with by the MHRA's Vigilance and Risk Management of Medicines (VRMM) Division.
The guideline was developed in collaboration with pharmaceutical industry representatives under the Better Regulation of Medicines Initiative (BROMI). The draft also includes a new procedure for reclassifications designed to streamline the existing process.
MHRA - How to Change the Legal Classification of a Medicine in the UK
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