Swissmedic Annual Report 2018

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88 Corporate Governance Revenues Swissmedic is financed through fees and levies, payments from the federal government for public services provided and through payments received for services rendered to third parties. To ensure that its control activities are efficient, the Agency is managed according to the principles of good business practice. Revenues in 2018 As a percentage of total revenues Fees 33,183 35.93 % Levies 44,662 48.36 % Payments from the federal government 14,056 15.22 % Payments received for services rendered to third parties 150 0.16 % Agency Council The Agency Council is Swissmedic’s supervisory body. It comprises a maximum of seven members and is appointed by the Federal Council, which also designates the chair. Three members may be proposed by the Cantons. The term of office is four years. The duties of the Agency Council are similar to those of the board of directors of a public limited company. In its capacity as a strategic body, the Agency Council represents Swissmedic’s interests vis-a-vis the Federal Office and the Federal Council. It also tasked with approving the Swissmedic budget, annual accounts and Annual Report. The Agency Council’s responsibilities are set out in Art. 72 of the Therapeutic Products Act (TPA; the applicable version in the reporting year). Member In office since Dr. Stéphane Rossini (C) 2018 Ms. Vincenza Trivigno (VC) 2016 Dr. iur. Lukas Engelberger 2017 Prof. Olivier Guillod 2014 Prof. Reto Obrist 2010 Prof. Marie-Denise Schaller, MD 2018 Mr. Giovan Maria Zanini 2014 C = Chair; VC = Vice-Chair The Agency Council comprises the following members (as at 31 December 2018):
Corporate Governance 89 Chair Stéphane Rossini, Dr. Professor & Consultant, Universities of Geneva and Neuchâtel; R&EEC Etudes Evaluations Conseils Vincenza Trivigno, lic. rer. pol. State Chancellor, Cantonal Chancellery, Canton of Aargau Reto Obrist, Prof. Dr. med. Former chief physician for oncology, Valais Health Network Marie-Denise Schaller, Prof. MD Retired; chief physician, department of Adult Intensive Care Medicine, Lausanne University Hospital Lukas Engelberger, Dr. iur., LLM Chair of the Department of Health and Member of the Executive Council of Canton Basel-Stadt Giovan Maria Zanini, Pharmacist Cantonal Pharmacist, Department of Health and Social Services, Canton of Ticino Olivier Guillod, Prof. Dr. Director of the Health Law Institute Neuchâtel, Neuchâtel The CVs and details of the vested interests of the individual members of the Agency Council can be found on the Swissmedic website.
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Annual Report 2018
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3 Contents Foreword by Stéphane Ro
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5 Standards Legal framework Legisla
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7 Raimund Bruhin, director “Not t
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9 The situation subsequently calmed
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11 Basis for development cooperatio
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13 Better protection against defect
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15 undercover investigations in one
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17 Autologous transplant products T
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19 Temporary authorisation: rapid a
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21 Number of authorisations by disp
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Market access | Marketing authorisa
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35 Variations requiring approval an
Page 37 and 38: Market access | Marketing authorisa
Page 39 and 40: Market access | Licensing 39 Licens
Page 41 and 42: Market access | Licensing 41 Clinic
Page 43 and 44: Market access l Inspections 43 Insp
Page 45 and 46: Market access l Inspections 45 GLP
Page 47 and 48: Market access | Licensing 47 Licens
Page 49 and 50: Market access | Licensing 49 Analys
Page 51 and 52: Market access | Medicinal products
Page 61 and 62: Market access | Medical devices 61
Page 67 and 68: Standards 67 Standards Legal framew
Page 69 and 70: Standards 69 Pharmacopoeia The phar
Page 71 and 72: Penal law 71 Investigative measures
Page 73 and 74: Penal law 73 Decisions / verdicts b
Page 75 and 76: Stakeholder management 75 Press rel
Page 77 and 78: Stakeholder management 77 Events Sw
Page 79 and 80: Stakeholder management 79 Collabora
Page 81 and 82: Stakeholder management 81 • Swiss
Page 83 and 84: Stakeholder management 83 Special a
Page 85 and 86: Information technology and telecomm
Page 87: Corporate Governance 87 Agency Coun
Page 91 and 92: 91 Remuneration Remuneration for th
Page 93 and 94: Organisation 93 Members of the Vete
Page 95 and 96: Organisation 95 Nicole, Messi Mara,
Page 97 and 98: Balance sheet 97 Balance sheet (in
Page 99 and 100: Erfolgsrechnung 99
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Swissmedic Annual Report 2018

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