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 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

Added a link to the PAR for Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension 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

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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. We have updated the attachment for the the approved reclassification. Now showing data from 1991 up to 30 September 2019. 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. 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 There are different types of reclassification procedure depending on the company’s reclassification proposal. Major and standard reclassifications

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 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. 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. ThePharmacy ( P) - an intermediate level of control, can be bought only from pharmacies and under a pharmacist’s supervision; 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. MHRA guidance on the application for exclusivity for change in legal status of a medicine Legal status of substances

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. 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:

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. Added new PAR on the reclassification of Benacort Hayfever Relief for Adults 64 micrograms, nasal spray from POM to GSL Added a link to the Public Assessment Report for the reclassification of Almerg 180mg film-coated tablets Stakeholder 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! MHRA assesses the application once it has been submitted formally. Depending on the nature of the proposed classification, the MHRA might also take advice from its committees of external experts, consult a group, (‘stakeholder group’), comprising health professionals and representatives of people affected by the classification change and run a public consultation.

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;

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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