Swissmedic Annual Report 2018

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66 Standards
Standards 67 Standards Legal framework Legislation Swissmedic’s legal mandate, its areas of competence and its enforcement role in the therapeutic products sector are laid down in binding laws and ordinances. In a rapidly evolving environment, legislation work that helps enact and maintain legal foundations is one of Swissmedic’s key tasks. The lead entity for enacting and revising the Therapeutic Products Act (TPA) and the implementing ordinances (both issued by the Federal Council) at administrative level is the Federal Office of Public Health (FOPH). Swissmedic is integrated within this legislative work as the competent enforcement authority. It is, however, one of Swissmedic’s competencies to enact and revise the implementing ordinances (ordinances of a technical nature) of the Swissmedic Agency Council. Activities • The changes to legislation adopted by Parliament on 18 March 2016 as part of the regular revision of the Therapeutic Products Act (TPA2) resulted in extensive amendments to the implementing legislation. In partnership with the FOPH, Swissmedic launched a legislative project for the associated ordinances at Federal Council and Agency Council level in March 2016. This project, known as Therapeutic Products Ordinance Package IV or HMV IV, was completed at the end of 2018. The Agency Council approved five ordinances in resolutions passed on 4 May, 7 September and 14 September 2018: –– Ordinance of the Swiss Agency for Therapeutic Products on the Licensing Requirements for Therapeutic Products (TPLRO) –– Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (TPLO) –– Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Complementary and Phytotherapeutic Products (KPTPO) –– Ordinance on Fees Levied by the Swiss Agency for Therapeutic Products (FeeO-Swissmedic) –– Ordinance on the Personnel of the Swiss Agency for Therapeutic Products (Swissmedic Personnel Ordinance) On 21 September 2018, the Federal Council passed resolutions on three additional ordinances. –– Therapeutic Products Ordinance (TPO) –– Ordinance on the Assignment of Responsibility for Therapeutic Products Monitoring to the Swiss Agency for Therapeutic Products (Therapeutic Products Monitoring Ordinance) –– Ordinance on the Advertising of Therapeutic Products (TPAO) All revised ordinances came into force on 1 January 2019. • On 29 September 2017, Parliament approved the proposal to approve and implement the Medicrime Convention in the final vote. The proposal included the adaptation of specific aspects of the Therapeutic Products Act (TPA) and the Criminal Procedure Code (CrimPC). In addition to the legal amendments associated with the ratification of the Medicrime Convention, the option of attaching safety features and devices to medicinal products packaging in Switzerland was also approved. The features and devices in question are similar to those provided for in the EU’s Falsified Medicines Directive (2011/62/EU). The provisions on safety features and devices are due to be submitted for consultation in the second half of 2019. The Federal Council enacted the implementing provisions of the Medicinal Products Licensing Ordinance (MPLO) on 14 November 2018, and these entered into force on 1 January 2019. • On 5 April 2017, the EU approved its new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Since Switzerland is a participant in the European single market for medical devices, it has to enact the new Regulations in its national legislation in timely fashion. In adapting its legislation to the European Regulations, Switzerland is also seeking to improve the safety and quality of medical devices. Doing so will also create the framework for Switzerland’s continued access to existing and new EU databases and expert groups, which will in turn ensure effective and efficient market surveillance of medical devices in the country. Laws and ordinances will require extensive modification and the MRA (agreement between Switzerland and the EU on mutual recognition of conformity assessments) will also have to be modified to maintain the equilibrium between European regulations and Swiss legal foundations. The FOPH is carrying out the legislative work in
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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
Page 15 and 16: 15 undercover investigations in one
Page 17 and 18: 17 Autologous transplant products T
Page 19 and 20: 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 63 and 64: Market access | Medical devices 63
Page 65: Market access | Medical devices 65
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 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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