con007545.docx

1、con007545MHRA GUIDANCE NOTE 11CHANGING THE LEGAL CLASSIFICATION IN THE UNITED KINGDOM OF A MEDICINE FOR HUMAN USEINTRODUCTION1. 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 i

2、s 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

3、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 ch

4、anging 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 genera

5、l 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 Commissions website in the Rules Governing Medicinal Products in the European Community Vol

6、ume 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 Am

7、anda Williams on 020 7084 2523 (advice on applications) or Miss Amanda Lawrence on 020 7084 2366 (on process).BACKGROUND4. 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 categorie

8、s: 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

9、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. T

10、he 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 ap

11、plication 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.PROCEDURES FOR RECLASSIFICATIONTypes of Application7. Following rec

12、eipt 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 STANDA

13、RD 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

14、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 qu

15、antity,as the medicinal product in relation to which the application is made. Fees8. 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 w

16、here the MHRA are satisfied that the classification does not need to be considered by the relevant committee, half the fee will be refunded.If there is an analogous product with that classification (see above), a Standard Type II variation fee will be payable.Bulk fees are applicable when the same a

17、pplicant makes the same changes to more than one product at the same time, having the same active(s). Consultation and advice9. Public consultation with interested parties for a 4 or 6 week period (6 weeks for Complex applications) will take place at different points in the two procedures. Consultat

18、ion will take place immediately in the Standard procedure and will be based on the applicants Reclassification Summary (see below). In the Complex procedure, public consultation will only take place after the advice of the committee has been sought and they have recommended that reclassification sho

19、uld take place. A flow-chart showing the steps involved in reclassification is provided in Appendix 2.10. The advisory committee is invited to comment on straightforward (Standard) applications during the public consultation period. Complex applications are submitted for advice in the first instance

20、 and released for consultation following positive advice. Standard applications on which issues have been raised in consultation may also require committee advice. There is a right of appeal to the Medicines Commission (MC) on applications refused.Standard Procedure11. This process will generally ta

21、ke up to 120 calendar days, not including the consultation. Valid applications will be submitted immediately for consultation, via the MHRA website, to interested parties including members of the relevant committees. Interested parties will be notified of new consultations.12. Applications will only

22、 be submitted for formal review by the advisory committee if issues are raised as a result of the consultation process or of the review of the supporting data by the MHRA Secretariat. Members of the relevant committee may also request that the full application be referred to another committee or to

23、MC. Such committee referral will, of necessity, lengthen the time to final determination. The applicant may also be approached for additional information in relation to specific concerns and any such action would again increase the time required to determine the application.13. Upon determination, t

24、he applicant will be informed of the outcome. Favourable decisions on applications will be implemented depending on what type of application was submitted, by including the new legal classification in the grant of the new MA, the renewed MA or the variation to the existing MA. Reclassified products

25、will then be listed in the next available Medicines Act Information Letter (MAIL) and on the MHRA website.14. In the case of applications not approved, the reasons for the decision will be notified to the applicant who will also receive the assessment report. Applicants will be given the opportunity

26、 to appeal by written representation to MC. Complex Applications15. This process will generally take up to 180 calendar days, not including the consultation. Applications will be assessed by the MHRA Secretariat, and submitted to the relevant committee for consideration. 16. If reclassification is r

27、ecommended, consultation will take place with interested parties via the MHRA website on a rolling cycle as and when applications are made. Provided that no outstanding issues remain following the consultation procedure, action as in the Standard procedure will be instigated. Notification and opport

28、unity for appeal will be given if reclassification is not recommended.Applications not supported by data17. Follow on “me too” reclassifications (not supported by full data) for products where an analogous product has already been reclassified are dealt with by the variation procedure. There is no p

29、ublic consultation or referral to the advisory committee for these applications. Timetables18. Applications may be made at any time during the year. There are certain constraints on the process imposed by the timing of meetings of the relevant committee and any other committee involved; MHRA will st

30、rive to meet the time-scales indicated but these cannot be guaranteed.Form of application19. Applications can be made by both MA holders and by other interested parties. Applications from MA holders should be made as part of a new MA application, a renewal application or a variation application made

31、 in the usual way. It should be noted that, as classification is determined on a national basis, the position of MAs determined via the Mutual Recognition (MR) procedure may require special consideration and applicants are advised to discuss with MHRA at an early stage.20 If an applicant wishes to r

32、etain a POM product without some of the restrictions proposed for the P product, a new MA application rather than a variation must be made for the P product. The applicant will then have separate licences for the POM and P products. MA holders are reminded that where products of identical composition exist as both POM and P products, with different indications, the two products must be distinguishable by name since it would give rise to safety concerns for the two products to exist under identical names. These principles also apply to P to GSL switches.21. For any o