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: The legal classification of a medicine may sometimes change—we call this reclassification. It is also sometimes called ‘switching’. Growing confidence of the medicine’s role and improved understanding of its side effects can lead to a change in classification. Prescription-only medicine ( POM) to pharmacy ( P) medicine We have updated the attachment for the the approved reclassification. Now showing data from 1991 up to 30 September 2019. a risk management plan ( RMP) outlining the important risks associated with the reclassification of the product and the plans to manage these risks A medicine will be non-prescription unless it fulfils the criteria for prescription control as set out below.

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. 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. 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.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. 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.

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.

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Added new PAR on the reclassification of Benacort Hayfever Relief for Adults 64 micrograms, nasal spray from POM to GSL MHRA guidance on the application for exclusivity for change in legal status of a medicine Legal status of substances With the perfect balance of user submitted amateur porn videos, licensed content and partner videos, YouPorn has collected tens of thousands of the world's best free porn videos and continues to add hundreds of new videos to its collection every day. Added link to Public Assessment Report of the Reclassification of Benacort Hayfever Relief for Adults 64 micrograms, nasal spray, in the section on Public Assessment Reports. The MHRA will tell the requesting organisation of the outcome of the classification application and it will give reasons for the decision.