Swissmedic Annual Report 2018

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Penal law
Penal law 73 Decisions / verdicts by Swissmedic and by courts After the investigation phase, cases are subject to a decision on a penalty. Alternatively they may be transmitted to the competent court or proceedings may be closed. Swissmedic represents the prosecution in cases that are brought before a court. Activities • A total of 28 natural persons and 17 legal entities were affected by the 21 penalties that were imposed. Thirteen cases concerned illegal manufacture and trading, including illegal import, export and wholesale trading. Three cases involved illegal advertising. There were also three violations of the duty to report non-compliance, two breaches of due diligence obligations and one violation of the duty to cooperate. • Five sentences were passed following appeals against imposed penalties. Three of these concerned illegal trading, one involved illegal advertising and one was a breach of the duty to cooperate. • Swissmedic dismissed nine cases in which suspicions were not confirmed. In two cases, the individuals concerned were obliged to pay procedural costs. Furthermore, illegal products were confiscated in two cases in anticipation of their destruction. • The verdict of the Cantonal Court of Valais in response to an appeal by Swissmedic in a case involving the falsification of expiry dates of cancer medicines is worthy of note. The Court largely confirmed the verdict of the court of first instance. Nevertheless, it increased the penalty imposed on one of the defendants. Swissmedic lodged an appeal with the Federal Supreme Court, primarily in a bid to get the courts to recognise the health risk to patients. However, the Federal Supreme Court adhered strictly to legal precedent and rejected the appeal. Fortunately, the situation will be different in the future in that a potential (abstract) risk will be sufficient to justify a prison sentence. • A court in St Gallen confirmed the essence of two penalty rulings issued by Swissmedic in 2017, under which a fine had been imposed on a pharmacist who had been trading wholesale in medicinal products for many years despite not having a licence to do so and had also been supplying medicinal products to a doctor who was not licensed to dispense them. The court ruling also confirmed the damages imposed on this pharmacist, which were equivalent to the profit of around CHF 40,000 that had been earned from these activities. 21 5 2018 0 20 2017 Penalties imposed Cantonal judgements Federal Supreme Court judgements 3 0 13 2 2016 0
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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
Page 21 and 22: 21 Number of authorisations by disp
Page 23 and 24: Market access | Marketing authorisa
Page 35 and 36: 35 Variations requiring approval an
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: Penal law 71 Investigative measures
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 and 88: Corporate Governance 87 Agency Coun
Page 89 and 90: Corporate Governance 89 Chair Stép
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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