Uploaded PARs for Voltarol 140 mg Medicated Plaster, InVita D3 400IU soft capsules and InVita D3 800IU soft capsules

product information - summary of product characteristics ( SPC), labelling and patient information leaflet ( PIL) 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 a direct or indirect danger exists to human health, even when used correctly, if used without medical supervision 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 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.

Word History

The evidence needs to demonstrate that the risk to the public will be adequately managed. This may involve tying the proposed classification change to measures that include: varying or restricting

Over-the-counter ( OTC) medicines’ covers all general sale medicines and pharmacy medicines. The description conveniently distinguishes medicines that can be bought from those that must be prescribed. 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.General Sales List ( GSL) - may be bought from retail stores, such as a newsagent, a supermarket or a vending machine in a shop. A medicine will be non-prescription unless it fulfils the criteria for prescription control as set out below.

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 occasionally, removal of a general sale medicine category or a pharmacy medicine category, leaving the medicine classified into fewer categories 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. 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.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 We have updated the attachment for the the approved reclassification. Now showing data from 1991 up to 30 September 2019.