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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Other examples of pharmacy medicines include tablets for emergency contraception and medicines containing codeine for treating pain that is not relieved by aspirin, ibuprofen or paracetamol alone. General sale medicines Added a link to the Public Assessment Report of the Reclassification of Almerg 180mg film-coated tablets The term ‘over the counter medicines’ is informal and is not used in the UK medicines regulations. Changing the legal classification of a medicine The MHRA will tell the requesting organisation of the outcome of the classification application and it will give reasons for the decision.

a direct or indirect danger exists to human health, even when used correctly, if used without medical supervision 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 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) 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.

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. 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 Added a link to the Public Assessment Report for the reclassification of Almerg 180mg film-coated tablets 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. The evidence may comprise clinical studies, extensive clinical use indicating acceptable level of side effects, advice of experts, views of relevant health professionals and their professional bodies, as well as the views of relevant public associations and individuals with an interest in the medicine under consideration.