Added a link to the Public Assessment Report for the reclassification of Almerg 180mg film-coated tablets 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 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.

There are different types of reclassification procedure depending on the company’s reclassification proposal. Major and standard reclassifications Pharmacy ( P) - an intermediate level of control, can be bought only from pharmacies and under a pharmacist’s supervision;

The underlying principle for classifying medicines is to maximise timely access to effective medicines while minimising the risk of harm from inappropriate use. Making medicines available over-the-counter: the trade-offs Benefits

Revised the date under sub-heading 'Legal status of substances' to 30 September (formerly 31 March). Uploaded PARs for Voltarol 140 mg Medicated Plaster, InVita D3 400IU soft capsules and InVita D3 800IU soft capsules a direct or indirect danger exists to human health, even when used correctly, if used without medical supervisionAdded the public assessment report for the reclassification of Omeprazole 20mg Gastro-Resistant Tablets PAR 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. 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. Prescription-Only Medicine ( POM) - has to be prescribed by a doctor or other authorised health professional and it has to be dispensed from a pharmacy or from another specifically licensed place; 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 informationMHRA guidance on the application for exclusivity for change in legal status of a medicine Legal status of substances