Pom Pom"You're Off to Uni, Good Luck" Greeting Card

Product Information

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. A medicine will be non-prescription unless it fulfils the criteria for prescription control as set out below. MHRA guidance on the application for exclusivity for change in legal status of a medicine Legal status of substances

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. TheIn 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

a risk management plan ( RMP) outlining the important risks associated with the reclassification of the product and the plans to manage these risks 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 product information - summary of product characteristics ( SPC), labelling and patient information leaflet ( PIL)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. Revised the date under sub-heading 'Legal status of substances' to 30 September (formerly 31 March). 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. 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 General Sales List ( GSL) - may be bought from retail stores, such as a newsagent, a supermarket or a vending machine in a shop. 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 the public assessment report for the reclassification of Omeprazole 20mg Gastro-Resistant Tablets PAR

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; Added a link to the Public Assessment Report for the reclassification of Almerg 180mg film-coated tablets 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 There are different types of reclassification procedure depending on the company’s reclassification proposal. Major and standard reclassifications