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We have updated the attachment for the the approved reclassification. Now showing data from 1991 up to 30 September 2019. product information - summary of product characteristics ( SPC), labelling and patient information leaflet ( PIL) Added a link to the Public Assessment Report of the Reclassification of Almerg 180mg film-coated tablets 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.

Added the public assessment report for the reclassification of Omeprazole 20mg Gastro-Resistant Tablets PAR a risk management plan ( RMP) outlining the important risks associated with the reclassification of the product and the plans to manage these risksStakeholder 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!

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. The term ‘over the counter medicines’ is informal and is not used in the UK medicines regulations. Changing the legal classification of a medicine 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; is for sale or supply at the same quantity or a greater quantity as the medicinal product in relation to which the application is made On rare occasions, after thorough consideration by expert committees, the MHRA may decide that public health is best protected by removing over-the-counter availability of a medicine. In other words, reclassifying it from General Sale or Pharmacy to Prescription Only. In these cases the MHRA will work closely with affected companies to make the necessary changes. Types of reclassification procedure

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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 There are different types of reclassification procedure depending on the company’s reclassification proposal. Major and standard reclassifications

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. 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 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 Added new PAR on the reclassification of Benacort Hayfever Relief for Adults 64 micrograms, nasal spray from POM to GSLAll 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 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 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.