Swissmedic Annual Report 2017: achieving success through collaboration

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32 Market access | Marketing authorisation Veterinary medicinal products with a new active pharmaceutical ingredient authorised in 2017 Therapeutic area Active pharmaceutical ingredients Product name Application Interferons Pegbovigras timum Imrestor ad us. vet., solution for injection Pegylated bovine Granulocyte Colony Stimulating Factor for use in cattle Proton pump inhibitors Omeprazolum GastroGard ad us. vet., oral paste ACE inhibitors Spironolactonum Cardalis ad us. vet., chewable tablet Systemic ectoparasiticides Sarolanerum Simparica ad us. vet., chewable tablet Prevention and treatment of gastric ulcers in horses Treatment of chronic degenerative mitral valve disease with congestive heart failure in dogs Ectoparasiticide against fleas, ticks and mites for systemic use in dogs Veterinary Medicines Expert Committee (VMEC) The VMEC is a panel of experts providing support and advice to Swissmedic when authorisation documents relating to veterinary medicinal products require scientific assessment. Activities • At its four meetings in 2017, the VMEC assessed nine applications for authorisation or a variation of the authorisation. Extensions and discontinuations Authorisations for a veterinary medicinal product are issued for five years. The authorisation holder must apply for an extension of the authorisation: If the conditions continue to be met, the authorisation is extended for five years at a time. Discontinuing the marketing of a medicinal product or a dosage strength of the product is also subject to mandatory notification at least two months before marketing is ceased. Activities • In 2017, the authorisation was extended for 134 products. • At the same time, the authorisation holders discontinued the marketing of 27 products. • Applications to discontinue 12 products were completed, and the authorisations of 15 products were not extended.
33 Variations requiring approval and variations requiring notification A request must be submitted to Swissmedic for any chan ge to a veterinary medicinal product that has already been authorised. Minor variations can take the form of a notification, whereas variations requiring approval take the form of an application. The variations are examined with or without scientific assessment. Activities • In 2017, 173 variations requiring approval with scientific assessment and 296 variations requiring notification were completed. • The increase in the number of variations requiring notification compared to the previous year reflects the growing trend in the veterinary medicines business: These variation applications primarily concern the quality of authorised veterinary medicinal products, for example changes in the manufacturers of the active substances or the deposition of new Certificates of Suitability (CEP) issued by the European Directorate for the Quality of Medicines (EDQM). Minor Use – Minor Species (MUMS) The authorisation of veterinary medicinal products used only for minor animal species or for rare indications is not lucrative for the veterinary medicinal products industry because of the low sales volumes involved. Various therapeutic agencies therefore adopt supportive measures to enable the supply of these so-called MUMS products. In Switzerland veterinary medicinal products can be granted MUMS status if they are essential for defined minor animal species such as bees or fish. Once the Agency has granted MUMS status, the fees for processing the authorisation and variation applications are waived. Activities • No new MUMS status was granted during 2017. • One application for the authorisation of a product with a known active ingredient was approved. 2017 173 296 2016 179 203 2015 240 218 Variations requiring approval Variations requiring notification
Page 1 and 2: Annual Report 2017
Page 3 and 4: 3 Contents Foreword by Christine Be
Page 5 and 6: 5 Standards Legal matters 64 Legisl
Page 7 and 8: 7 Jürg H. Schnetzer Transposing th
Page 9 and 10: 9 Raimund Bruhin Mr Bruhin, you too
Page 11 and 12: 11 Improved public access to medici
Page 13 and 14: 13 This is an attractive process fo
Page 15 and 16: 15 Key issues in 2017 Increased saf
Page 17 and 18: 17 Entry into force of the revised
Page 19 and 20: 19 Number of authorisations by disp
Page 21 and 22: 21 Authorisation of human medicinal
Page 23 and 24: Market access | Marketing authorisa
Page 27 and 28: 27 Applications under Article 13 TP
Page 31: Market access | Marketing authorisa
Page 37 and 38: Market access | Licensing 37 Licens
Page 39 and 40: Market access | Licensing 39 Import
Page 41 and 42: Market access l Inspections 41 Insp
Page 43 and 44: Market access l Inspections 43 GLP
Page 45 and 46: Market access | Licensing 45 Licens
Page 47 and 48: 47 Analysis conclusions for new mar
Page 49 and 50: Market access | Medicinal products
Page 53 and 54: 53 Risk mitigation measures It is m
Page 59 and 60: Market access | Medical devices 59
Page 61 and 62: Market access | Medical devices 61
Page 63 and 64: 63 Special activities and events: M
Page 65 and 66: Standards 65 Pharmacopoeia The phar
Page 67: Penal law 67 Investigative measures
Page 70 and 71: 70 Stakeholder management Stakehold
Page 72 and 73: 72 Stakeholder management Publicati
Page 74 and 75: 74 Stakeholder management Transpare
Page 76 and 77: 76 Stakeholder management External
Page 78 and 79: 78 Stakeholder management • Swiss
Page 80 and 81: 80 Telematics / Information Telemat
Page 82 and 83:
82 Corporate Governance Organisatio
Page 84 and 85:
84 Corporate Governance Revenues Sw
Page 86 and 87:
86 Corporate Governance Management
Page 88 and 89:
88 Organisation Organisation Swissm
Page 90 and 91:
90 Organisation Our staff - our cap
Page 92 and 93:
92 Income statement Income statemen
Page 94 and 95:
94 Products funded mainly by the Co
Page 96:
Schweizerisches Heilmittelinstitut
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Swissmedic Annual Report 2017: achieving success through collaboration

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