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When authorising new medicinal products, Swissmedic bases its decisions on internationally acknowledged criteria. The products may only be placed on the market if their quality, safety and effectiveness are sufficiently evaluated and proved. If the criteria for authorisation are fulfilled, Swissmedic
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and was created by the
Federal Act on Medicinal Products and Medical Devices. It is independent in organization and management and has authority over its own budget. Swissmedic has 300 full-time employees.
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grants the marketing authorisation, specifies the method of sale (on prescription only/dispensing point) and approves the information for healthcare professionals and the patient information.
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Any medical products for humans or animals need approval from
Swissmedic to be brought on the Swiss market. Moreover, Swissmedic must be notified of all
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Costs of approval are paid by the applicant. Approval must be renewed after five years.
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surveillance authority for medicines and medical devices, registered in
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Medicine licensing and inspection authority in
Switzerland
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Federal Act on
Medicinal Products and Medical Devices
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49:Schweizerische Arzneimittelnebenwirkungszentrale
63:Swissmedic is a federal institution subject to
45:Interkantonale Kontrollstelle für Heilmittel
47:(IKS), which was itself the successor of
51:(SANZ). Swissmedic is affiliated to the
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192:National agencies for drug regulation
29:Swiss Agency for Therapeutic Products
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187:Federal Department of Home Affairs
53:Federal Department of Home Affairs
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92:Dispensing category (Switzerland)
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80:conducted in Switzerland.
177:Pharmaceuticals policy
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90:Further information:
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130:Swissmedic Guidances
97:Notes and references
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153:46.9523°N 7.4355°E
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23:Logo of Swissmedic
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125:Official website
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78:clinical studies
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119:External links
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72:Functions
59:Structure
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41:Bern
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