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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)
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 introduction of one or more additional legal classes. For example, a prescription-only medicine may additionally be classified into a pharmacy medicine category or a general sale medicine category. In such a case, the quantity, dose and the conditions for which the medicine is used may be restricted when it is supplied within the new categories compared to the original prescription-only category All applications which are not for an analogous product should be submitted as major, and these will be downgraded to standard, if required during the assessment process. Simple reclassification General sale medicines are taken for common, easily recognised ailments which usually last around 2–3 days. These medicines cause few troublesome side effects in normal use. Pharmacy ( P) - an intermediate level of control, can be bought only from pharmacies and under a pharmacist’s supervision;
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 occasionally, removal of a general sale medicine category or a pharmacy medicine category, leaving the medicine classified into fewer categories 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 direct or indirect danger exists to human health, even when used correctly, if used without medical supervision Added a link to the Public Assessment Report of the Reclassification of Almerg 180mg film-coated tablets
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We have updated the attachment for the the approved reclassification. Now showing data from 1991 up to 30 September 2019.
In general, prescription-only medicines are used for conditions that are best diagnosed and managed by health professionals. Examples of prescription-only medicines include virtually all antibiotics and medicines for treating high blood pressure. Pharmacy medicines 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. There are different types of reclassification procedure depending on the company’s reclassification proposal. Major and standard reclassifications is for sale or supply at the same quantity or a greater quantity as the medicinal product in relation to which the application is madeAdded a link to the Public Assessment Report for the reclassification of Almerg 180mg film-coated tablets Added new PAR on the reclassification of Benacort Hayfever Relief for Adults 64 micrograms, nasal spray from POM to GSL 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 The term ‘over the counter medicines’ is informal and is not used in the UK medicines regulations. Changing the legal classification of a medicine 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
The MHRA will tell the requesting organisation of the outcome of the classification application and it will give reasons for the decision. 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: 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. 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. MHRA guidance on the application for exclusivity for change in legal status of a medicine Legal status of substances
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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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