Date Insert on Master Slide Slide 1 Regulatory Framework within which patients can have safe and more convenient access to medicines Royal College of Physicians of Ireland, 25th March 2009 Dr.Olive Smyth

Slide 2 Role Of The IMB Protect and enhance public health through the regulation of human healthcare products. Among its many activities, the IMB regulates the prescription status and method of supply and promotion of all authorised medicines

Slide 3 EU Legislation Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolidated version : 21/03/2008). Amended by Directive 2004/27/EC

Slide 4 Classification Of Legal Status Key Principles (1) Harmonisation of basic principles of the classification for the supply of medicinal products across the EU Legal status is now part of the marketing authorisation. Criteria for prescription control outlined

Slide 5 Classification Of Legal Status Key Principles (2) Prescription status must include whether considered for renewable or non- renewable supply Non prescription status unless criteria for prescription control are met Further sub- classification possible at a national level

Slide 6 Irish Legislation Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2008 (S.I 510 of 2005,S.I No. 201 of 2007 and by S.I No. 540 of 2007, S.I 512 of 2008) Medicinal Products (Control of Placing on the Market) Regulations, 2007 SI 540 of 2007 Medicinal Products (Control of Advertising) Regulations, 2007, SI No 541 of 2007 Pharmacy Act 2007

Slide 7 IMB Role Determination of prescription status Determination of method of supply and promotion Maintenance of a publicly available list of classifications and subcategories

Slide 8 Criteria For Classifying Product Subject To Prescription Control Is likely to present a direct or indirect danger to human health even when used correctly or without the supervision of a doctor Is frequently and to a very wide extent used incorrectly and as a result is likely to present a direct or indirect danger to human health Contains substances or preparations of substances of which the activity requires, or the side effects require further investigation Is normally prescribed by a doctor for parenteral administration

Slide 9 Prescription Only Medicine Subclassification Renewable – B classification in schedules Non Renewable Restricted or Special - A classification in schedules Radiopharmaceuticals – C classification

Slide 10 Non-prescription Status Subclassification 2 subcategories Pharmacy only  Supplied in a retail pharmacy business by or under the personal supervision of a registered pharmacist General sales  Supplied in a retail pharmacy and non- pharmacy retail outlets (available for self selection) the IMB must be satisfied that the product can with reasonable safety be sold without the supervision of a pharmacist

Slide 11 Reclassification Procedure Previously required parallel application to DoHC to amend regulations Applications to reclassify are evaluated by IMB with advice from relevant experts/ Sub-committees. Applications can be made as variations or new applications/line extension depending on the proposed changes EU / National timelines apply

Slide 12 Safe to be supplied without a prescription? Reclassification from prescription only to pharmacy only Reclassification from pharmacy only to GSL The applicant must demonstrate that the 4 criteria do not apply and the product can safely be excluded from prescription control

Slide 13 Authorisation Emphasis on safety assessment Clinical expert report Safety review PSUR data Postmarketing data Experience from other jurisdictions Product information (Readability & User test) Risk management plan (Info and training material) New safety /efficacy data (1yr period of exclusivity

Slide 14 Post authorisation Pharmacovigilance Consumer reporting of adverse events Maintenance of Risk Management Plans