Switzerland’s Healthcare and Pharmaceutical sectors are internationally recognized for quality and innovation. For companies seeking authorization and supply of their medicinal/transplant/ gene therapy products on the Swiss market, an Establishment License is mandatory and can cover a range of GxP activities performed in Switzerland (e.g. manufacture, import, market release, and wholesale), export from Switzerland and trade in foreign countries. An Establishment License is issued on the basis of a successful inspection by the responsible cantonal inspectorate or by the Swiss Agency for Therapeutic Products (Swissmedic), depending on the type of product.
The SFL free webinar will cover key aspects for any company seeking to secure an Establishment License:
• What is the Establishment License and why apply for it?
• Minimum application criteria
• Responsible Person (RP) requirements
• Setting up a Quality Management System (QMS)
• Inspections and preparation
• Post-inspection activities