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Guidance Note No 11 1 MHRA GUIDANCE NOTE 11 CHANGING THE LEGAL CLASSIFICATION IN THE UNITED KINGDOM OF A MEDICINE FOR HUMAN USE

INTRODUCTION 1. A new medicine, when first authorised, is usually restricted to use under medical supervision and made available only on a prescription; a medicine restricted in this way is classified as a Prescription Only Medicine (POM). If, following experience gained during use, it can be demonstrated that the medicine is safe for use with pharmacist supervision, reclassification as a Pharmacy Medicine (P) may be undertaken by removing the prescription requirements to allow sale or supply from a pharmacy. If further experience demonstrates that access to professional advice is not required for safe use of the medicine, suitable presentations may then be reclassified as General Sale List (GSL) medicines to allow sale from a wider range of retail outlets.

2. Procedures for changing the legal classification of a medicine have been revised with a view to simplifying and speeding the process wherever possible and providing greater transparency. This booklet replaces earlier advice on legal and administrative requirements for reclassification. It should be treated as general advice and not as a complete and authoritative statement of the law. The European guideline on changing legal classification for the supply of medicinal products is also relevant and can be accessed via the Commission’s website in the Rules Governing Medicinal Products in the European Community – Volume IIIB - Guidelines.

3. Requests for change of legal classification of substances and associated policy matters are dealt with by the Post-Licensing Division of Medicines and Healthcare products Regulatory Agency. Further information on the new reclassification procedure may be obtained from Mrs Amanda Williams on 020 7084 2523 Guidance Note No 11 2

(advice on applications) or Miss Amanda Lawrence on 020 7084 2366 (on process).

BACKGROUND 4. The sale and supply of medicines is controlled by the Medicines Act 1968 and Directive 2001/83/EC. All medicines are classified according to one of the three following categories:  Prescription Only Medicines (POM) – available only on a prescription  Pharmacy (P) – available under the supervision of a pharmacist  General Sale List (GSL) – available in general retail outlets such as supermarkets. The presumption under law is that all medicines are P unless they meet the criteria for POM or GSL status. Pack size restrictions for GSL products are listed in the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980.

5. Since 1 April 2002 changes in legislation mean that for all licensed medicines, legal status is determined by the Marketing Authorisation (MA).

6. The reclassification procedures are outlined below. If the guidance does not appear to describe adequately any particular circumstance relevant to an application, please contact Post-Licensing Division at the contact points listed on page 1. Applicants who are considering making a reclassification application are encouraged to discuss their proposals and prospective timetable with MHRA prior to submission. Contact numbers for discussion of professional aspects are listed in the MAIL bulletin, see contact points listed on page 1. Guidance Note No 11 3

PROCEDURES FOR RECLASSIFICATION Types of Application 7. Following receipt in MHRA, applications are validated and sifted on a triage basis. The reclassification process depends on the type of application. A major change requiring Committee referral will be allocated to the COMPLEX procedure and a change not requiring Committee referral will be allocated to the STANDARD procedure. A ―me-too‖ application based on an analogous product, which has already completed the reclassification procedure, may be dealt with simply as a variation. For these purposes, an analogous medicinal product is a medicinal product, which has a United Kingdom marketing authorisation or a Community marketing authorisation and which— (a) has the same active ingredient, route of administration and use; (b) has the same strength or a higher strength; (c) has the same dosage or daily dosage, or a higher dosage or daily dosage; and (d) 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. Fees 8. In line with these new categories, a new fee structure has been put in place. A higher fee is payable on all Complex applications requiring committee referral. For a Standard application the full fee is levied but where the MHRA are satisfied that the classification does not need to be considered by the relevant committee, half the fee will be refunded.