Pharmacy ( P) - an intermediate level of control, can be bought only from pharmacies and under a pharmacist’s supervision; The three legal categories are explained here, with examples of medicines in each of the categories. We also explain how the categories relate to the term over-the-counter ( OTC) medicines. Prescription-only medicines Companies are encouraged to ask for scientific advice from the MHRA on how to apply for a classification change and what evidence needs to be submitted. The A reclassification is major if, for example, it’s the first in a new therapeutic category or a new target population for an existing product. Major reclassifications must be referred to an expert committee. a risk management plan ( RMP) outlining the important risks associated with the reclassification of the product and the plans to manage these risks

In the UK these criteria are laid down in the Human Medicines Regulations 2012, regulation 62(3). Pharmacy medicine ( P) to the general sale list ( GSL) We have updated the attachment for the the approved reclassification. Now showing data from 1991 up to 30 September 2019. Added a link to the PAR for Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension Added the public assessment report for the reclassification of Omeprazole 20mg Gastro-Resistant Tablets PARStakeholder groups are composed of representatives from the public and health professionals. Their input takes the form of a half-day meeting on an ad hoc basis when we have an application for a specific medicine. Each meeting will discuss the possible reclassification of a specific prescription-only medicine to a pharmacy medicine or a pharmacy medicine to a general sales medicine. Stakeholder Groups consider a proposed reclassification in the early stages of processing a reclassification application. Get involved!

MHRA guidance on the application for exclusivity for change in legal status of a medicine Legal status of substances More detailed information on the POM to P or P to GSL reclassification process can be found in our Guidance on how to change the legal classification of a medicine in the UK. occasionally, removal of a general sale medicine category or a pharmacy medicine category, leaving the medicine classified into fewer categories

Word History

A simple reclassification should be made as a type IB or type II variation, and the timetable follows the normal timetable detailed in the link. The variation application should include details of the analogous product. Additional information A company applying for a medicine to be classified either as a pharmacy medicine or a general sale medicine, needs to first collect the evidence that it is likely to be used appropriately and with relatively little danger to the public. Uploaded PARs for Voltarol 140 mg Medicated Plaster, InVita D3 400IU soft capsules and InVita D3 800IU soft capsules

A proposal to change a medicine’s classification needs to be supported by good evidence that focuses on the risk to the public on changing the classification. Listed below are the Public Assessment Reports (PARs) for reclassification applications that have not been subject to an ARM public consultation. These reports are published on the day an application is granted. People can buy products classified as ‘pharmacy medicines’ ( P) but only from a pharmacy and in the presence of a pharmacist. These medicines, also called ‘pharmacy-only medicines’, are not usually displayed on open shelves. product information - summary of product characteristics ( SPC), labelling and patient information leaflet ( PIL)Under the provisions of The Human Medicines Regulations 2012, regulation 62(5), GSL is appropriate for medicines which can, with reasonable safety, be sold or supplied otherwise than by or under the supervision of a pharmacist. A ‘simple’ application is based on an analogous product which has already been reclassified. An analogous product is a medicinal product which has a marketing authorisation, can be marketed in the UK and meets the following criteria: