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© Crown copyright 2005 Safeguarding public health Review of Unlicensed Medicines MHRA meetings with interested parties March 2011
Title: RUM progress report © Crown copyright 2005 Purpose of meeting To explore with interested parties latest thinking on ideas on reform developed by the RUM Steering Group Reflects responses to earlier consultation; also our understanding of the Coalition’s regulatory agenda Aim is to test out current thinking before revising and/or firming up proposals for formal consultation later in 2011 Looking for help in teasing out regulatory impact Health Warning! Specific ideas for reform presented are ideas for exploration and don’t necessarily represent official policy of MHRA or any others represented on RUM Steering Group
Title: RUM progress report © Crown copyright 2005 Review of unlicensed medicines Remit: Review UK use of the derogation permitted in Art 5.1 of Directive 2001/83/EC Coverage: UK “Specials” and associated import notification scheme RUM Steering Group: MHRA, Health Departments, NPSA, PASA Timetable 2007 Review set up: Feb 2008 Concept paper May 2009 Interim Report Late 2009 / early 2010 updating proposal in light of responses to consultation Late 2010 to date – update in light of Coalition’s regulatory agenda
Title: RUM progress report © Crown copyright 2005 Aims Prescribers able to take professional responsibility to supply unlicensed medicines to meet special needs Improve public health protection Clear responsibility/accountability for protecting patient safety and rights Meet Better Regulation principles: proportionality, targeting, consistency, transparency and accountability Arrangements to complement not undermine licensing of medicines
Title: RUM progress report © Crown copyright 2005 Where are we now? Proposals largely unchanged from earlier consultation Quality and manufacturing standards applying to Specials Strengthen pharmacovigilance Advertising Proposals changed since last consultation Patient information -Greater responsibility on healthcare professional to exercise judgement Proposal for structural reform of notification system covering both domestic manufacture and imports -Ideas for improved streamlining
Title: RUM progress report © Crown copyright 2005 Proposals largely unchanged………
Title: RUM progress report © Crown copyright 2005 Quality & Manufacturing Feedback Support for quality standards Support for development of BP monographs Some concerns about application of standards to low volume products; impact on small manufacturers Proposed approach Develop further guidance on application of GMP to these products Continue programme of developing BP monographs for unlicensed medicines
Title: RUM progress report © Crown copyright 2005 BP Monographs for Unlicensed Medicines The publication of a BP monograph provided a legally binding enforceable quality standard for unlicensed medicines Unlicensed Medicines in the BP -Supplementary chapter (non-mandatory) -General monograph (compliance mandatory) -Product monographs (compliance mandatory)
Title: RUM progress report © Crown copyright 2005 Supplementary Chapters Chapter V Introduction Legal requirements Ethical consideration and guidance Labelling Standards for preparation and manufacture Chapter V.a Preservative-free unlicensed medicines Chapter V.b Bioequivalence of oral suspension Chapter V.c (Draft for 2011 edition) Storage and shelf lives for unlicensed medicines Chapter V.d (Draft for 2011 edition) Formulations for Extemporaneous Preparations
Title: RUM progress report © Crown copyright 2005 General Monograph for Unlicensed Medicines Definitions Scope Production Labelling requirements Requirements for Formulated Preparations
Title: RUM progress report © Crown copyright 2005 Published Monographs for Unlicensed Medicines 2008 Caffeine citrate injection Caffeine citrate oral solution Dantrolene oral suspension Levomenthol cream Mercaptopurine oral suspension Paediatric phenobarbital oral solution Potassium chloride oral solution Sodium chloride oral solution Sodium fluoride oral solution
Title: RUM progress report © Crown copyright 2005 Published Monographs for Unlicensed Medicines 2009 Adrenaline and cocaine intranasal solution Captopril oral solution Cocaine paste Compound glucose, sodium chloride and sodium citrate oral solution Hydrocortisone sodium phosphate oral solution Potassium dihydrogen phosphate oral solution Vancomycin oral solution
Title: RUM progress report © Crown copyright 2005 Published Monographs for Unlicensed Medicines 2010 Allopurinol oral suspension Bapivacaine and fentanyl injection Chloral hydrate oral solution Magnesium glycerophosphate oral solution Midazolam oral solution Phosphate oral solution Propylene glycol solution Warfarin oral suspension
Title: RUM progress report © Crown copyright 2005 Work programme for monographs for Unlicensed Medicines 2011 Bupivacaine and diamorphine injection Clozapine oral suspension Dinoprostone oral solution Coal tar paste Coal tar and salicylic acid ointment Salicylic acid cream Salicylic acid ointment Silver nitrate solution Sodium chloride nebuliser solution Sodium carbonate oral solution Cefuroxime eye drops Disodium edetate eye drops
Title: RUM progress report © Crown copyright 2005 Pharmacovigilance – Proposals Introduction Pharmacovigilance (PhV) is a key activity in ensuring the safety of all medicinal products throughout their lifecycle. A significant element of effective PhV is the reporting and analysis of suspected adverse drug reactions (ADRs). Proposals Duty on UK manufacturers and importers to communicate to the MHRA all suspected (ADRs) – not just serious ADRs. Promote reporting of suspected ADRs by healthcare professionals and patients via the Yellow Card system.
Title: RUM progress report © Crown copyright 2005 Pharmacovigilance – The Future Consultation General support for strengthened PhV. Positive response to promoting Yellow Card reporting via patient and healthcare professional information. Concern regarding complexity and cost. Solutions Practical system – electronic reporting. Simplicity – report all suspected ADRs. Realistic timelines. Use patient and healthcare professional information to encourage Yellow Card reporting.
Title: RUM progress report © Crown copyright 2005 Advertising ■ It would be permissible to circulate simple price lists to potential healthcare professional customers in response to an enquiry provided no product claims are made. ■ It would be acceptable to promote the service offered.
Title: RUM progress report © Crown copyright 2005 Proposals developed further since last consultation…..
Title: RUM progress report © Crown copyright 2005 Patient Information Object of reform -Patient information requirements should be strengthened Options going forward -General support in the consultation for information with unlicensed medicines -No requirement for information in every case -BUT professional guidance will cover this
Title: RUM progress report © Crown copyright 2005 Labelling Object of reform - Labelling requirements should be strengthened Options going forward -Generally support in the consultation for standard labelling -Labelling should be in English -Labelling requirements should follow those set out in the British Pharmacopoeia and MHRA Guidance Note 25
© Crown copyright 2005 Safeguarding public health RUM: Structural Reform “option 8”
Title: RUM progress report © Crown copyright 2005 Requirements Must apply equally to importers and manufacturers Must have minimum possible regulatory impact Must provide regulatory oversight of key safety issues
Title: RUM progress report © Crown copyright 2005 Principles MHRA wishes to know about only products/activities: That raise safety concerns That may not meet special clinical need requirements
Title: RUM progress report © Crown copyright 2005 Previous Proposals Considered feedback Current Government policies -Together suggest previous proposals too complex (“option 7”) -New proposals developed (“option 8”)
Title: RUM progress report © Crown copyright 2005 Option 8 Manufacture/import of unlicensed medicines may be performed with minimal regulation (i.e. no notifications needed) for licence holders unless: -Change of category on master licence is required for manufacturers (MS) ·Variation for new categories -Item is on a “Restricted List” ·Variation required to permit import/manufacture Real-time feedback of changes via Risk Based Inspection (RBI) programme
Title: RUM progress report © Crown copyright 2005 Master Licences – activities Currently the MS has a range of categories of activities specified -Requires rationalising -May need some new categories/sub-categories Categories may be added by means of variation MHRA will conduct survey to assist rationalisation -Probably no fee for resulting updates
Title: RUM progress report © Crown copyright 2005 Restricted List - products A licence holder must apply for their licence to be varied for items on this list to be added to their licence Application similar to current import notification (28 days etc.). Granted variation will have appropriate validity period Provision for urgent applications (incl. Out-of-hours) Assessment against risk and compliance with licence Fee per variation. New variation required on expiry Additional fee for referral to Expert Committee
Title: RUM progress report © Crown copyright 2005 Example Restricted List Products with the same drug substance and pharmaceutical form as products with EU or UK national licences, except where prepared from these licensed products, or from another “notified” unlicensed product. Public listings of licensed products can be made available Products from outside the EEA Imported products not licensed in the country of origin Specific products with safety concerns
Title: RUM progress report © Crown copyright 2005 Notifications under RBI Programme – MS holders Changes within existing licence categories to be notified via Inspectorate -Where new API used for manufacture of a product from raw materials (i.e. not from another product) ·- aims to capture “unknowns” -Could exclude unlicensed products with BP Monographs ·(but these could still appear on Restricted List) -Could also publish guidance giving acceptable APIs to limit number of notifications required
Title: RUM progress report © Crown copyright 2005 Decision Tree
Title: RUM progress report © Crown copyright 2005 Preliminary Impact Assessment “ Back of envelope” estimate of volumes Review of import notifications and of sample product lists from large specials manufacturers The total numbers falling within the restricted list was less for manufacturers than importers by a factor of approximately 1:5 -many products are prepared from existing licensed products and are thus not in the Restricted List Currently, the total number of notifications per annum from importers is ~75,000 ~10% of this is expected under Option 8 from importers. If manufacturers notify ~20% of this, a total of ~10,000 submissions per annum might be expected under Option 8
Title: RUM progress report © Crown copyright 2005 English Language Labelling MHRA is aware that these will impact particularly on importers Comments invited
Title: RUM progress report © Crown copyright 2005 Transitional Arrangements Under consideration: Variation applications during introductory year -Used to gather data and set baseline for licence holders -No fees in this period -Major issues only for regulatory action
Title: RUM progress report © Crown copyright 2005 Discussion….. Feedback welcome …..
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