Overview of IMB and Integration of Cosmetics
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1 Overview of IMB and Integration of Cosmetics Cosmetics Information Day, September 15 th 2010 Dr Lorraine Nolan Healthcare Products Distribution Irish Medicines Board 23 rd October 2008 Slide 1
2 Irish Medicines Board (IMB) Mission Statement To protect and enhance public and animal health through the regulation of medicines, medical devices and health care products 15 th September 2010 Slide 2
3 IMB s Roles Medicinal Products Human Use IMB Medicinal Products Veterinary Use Competent Authority Medical Devices Blood and Tissues & Cells 15 th September 2010 Slide 3
4 IMB Functions 1. Authorisation of medicinal products for Human (H) and Veterinary (V) use 2. Inspection and licensing of manufacturers (H & V) and wholesalers (H); GCP & Pharmacovigilance Inspection 3. Competent Authority for Medical Devices (MD), including designation of Notified Body 4. Competent Authority for Blood Directive and Tissues and Cells Directive, including inspection & vigilance 5. Approval of Clinical Trials (H) and clinical investigations (MD) 6. Pharmacovigilance/Vigilance (H, V& MD) 15 th September 2010 Slide 4
5 IMB Functions (cont.) 8. Controlled Drugs Licensing and Inspection 9. Quality Defects, Recalls, Exempt Products & Market Compliance 10. Issue of Export Certificates (H & V) 11. Issue of GMP Certificates (H & V) 12. Enforcement (H & MD) 13. International representative function 14. Advice to Government 15 th September 2010 Slide 5
6 Functions Transferred From DoHC 2001 Medical Devices 2005 Controlled Drugs 2010 Cosmetics 15 th September 2010 Slide 6
7 IMB: Some Facts & Figures Established under IMB Act 1995 (No. 29 of 1995) Formerly National Drugs Advisory Board (NDAB) Located in Kevin O Malley, House, Earlsfort Centre, Earlsfort Terrace, Dublin 2 Region of 260 staff members Assess & monitor over 6,700 Human Medicines 1,200 Veterinary Medicines 500,000 Medical Devices on the Irish market 15 th September 2010 Slide 7
8 IMB Website ( 15 th September 2010 Slide 8
9 IMB (Quarterly) Newsletter 15 th September 2010 Slide 9
10 IMB Structure 15 th September 2010 Slide 10
11 Compliance Department Structure John Lynch Director of Compliance Silvia Vasilkova PA to Director of Compliance Deirdre O'Regan GCP / PhV Nicola Mahon Inspection Administrator Anne Hayes Inspection Lauren Kerchner Administrator Paul Sexton GMP Patrick Costello Blood and Tissue Hugo Bonar Enforcement Joe Callan Executive Enforcement Fiona McEvoy Enforcement Administrator Yvonne Maloney Planning Kevin O'Donnell Market Compliance Deirdre Breen QDR Administrator Pat Walsh S&A Technical Paula Bradshaw Licensing Emily Hassett Licensing Administrator Patrick Keating Licensing Administrator Lorraine Nolan Healthcare Products Distribution Paula Dillon CD/GDP Inspector Alfred Hunt CD/GDP Inspector Donna McGowan GCP/PhV Inspector Greg McGurk Executive Sterile Chris Cullen Senior Inspector/ Non-Sterile Sinead Masterson Blood and Tissue Inspector Michal Olczyk Enforcement Administrator Laura Hickey S&A Technical Aedin Allen Licensing Administrator Catherine Neary CD/GDP Inspector Sinead Curran GCP/PhV Inspector Gerard Sheridan Sterile Inspector Mairead Finucane Medical Device Auditor Cormac Dalton Non-Sterile Inspector Victor Garvin Non-Sterile Inspector Alan Smullen Enforcement Aoife Farrell QDR Technical Conor Lydon Licensing Administrator Deirdre Ryan Technical Paul Moody Sterile Inspector Ciara Turley Inspector Niall McCarthy Enforcement Ciaran Wright Enforcement officer Tim O'Neill Enforcement Brenda Kirby Enforcement Thomas Neville Enforcement Technical Rob Smyth QDR Technical Lynn Barr Exempt Products Co-ordinator Breda Gleeson QDR Inspector Catherine Griffin Advertising Technical David McGlynn Licensing Administrator Naomi Howard Licensing Administrator 15 th September 2010 Slide 11 Nicola Hickie Cosmetics Project Orla Barry Technical
12 Compliance Department Structure John Lynch Director of Compliance Silvia Vasilkova PA to Director of Compliance Anne Hayes Inspection Hugo Bonar Enforcement Yvonne Maloney Planning Kevin O'Donnell Market Compliance Paula Bradshaw Licensing Lorraine Nolan Healthcare Products Distribution 15 th September 2010 Slide 12
13 Compliance Department Structure 6 person management team 5 sections Licensing, Market Compliance, Enforcement, Inspection (including Audit) and Healthcare Products Distribution Department headcount 54 Location 5 th Floor Alexandra House 15 th September 2010 Slide 13
14 Healthcare Products Distribution Section Established in Jan 2010 Restructuring of Compliance Department to include Healthcare Products Distribution Section Allow for integration of new areas of remit including cosmetics, distribution of medical devices. Incorporation of existing current remit relating to the distribution of medicinal products, regulation of controlled drugs, monitoring of general retail sales Focus of expertise on the regulation of the Healthcare Products supply chain 15 th September 2010 Slide 14
15 Healthcare Products Distribution Section Healthcare Product Distribution Cosmetics CD & Precursors Inspection & Reporting Inspection of Wholesale & monitoring of retail sales Medical Device Distribution (Future) Notifications Market Surveillance Rapex Assessment & Recalls PIF Review Inspection 15 th September 2010 Slide 15
16 Healthcare Products Distribution Section 7 member team Work in various technical roles Inspection resource (3) span a number of areas: medicinal product wholesale; CD & precursors; monitoring of retail sales Currently 2 members of staff specifically working on cosmetics with additional assistance from other team & IMB staff members 15 th September 2010 Slide 16
17 Cosmetics Team Nicola Hickie Cosmetics Project Orla Barry Market Surveillance Project Catherine Neary Inspector 15 th September 2010 Slide 17
18 Cosmetics Interfaces in Compliance Compliance Healthcare Products Distribution Licensing Cosmetics Other Functions Notifications Certificates of Free Sale Licensing & Authorisation 15 th September 2010 Slide 18
19 Cosmetics Interfaces in IMB Compliance Healthcare Product Distribution Safety Assessment Toxicological Evaluation Rapex Support Human Products Authorisation & Registration Pre-Clinical Assessment Cosmetics PIF Review Quality Defect & Rapex Assessment Inspection 15 th September 2010 Slide 19
20 Cosmetics Interfaces Externally RAPEX Alerts Market Surveillance Quality Defects RAPEX Alerts Recall 15 th September 2010 Slide 20
21 Cosmetics Information Day Thank you for your attention Happy to take questions within Q&A Session 15 th September 2010 Slide 21
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