Why is a Pharmaceutical Establishment License required in Switzerland?

Companies entering the Swiss healthcare market are often surprised to learn about one specific regulatory requirement: the Pharmaceutical Establishment License (PEL)

While it may appear as an additional regulatory step, the purpose of the PEL in Switzerland is clear. It ensures that:

• responsibilities are clearly defined at the local level

• quality and compliance standards are consistently maintained

• patient safety is safeguarded throughout the product lifecycle

• regulatory accountability is transparent and traceable

  
  

Comparable establishment licenses also exist across Europe for manufacturing, import and wholesale activities. Switzerland stands out by bundling these responsibilities into a central, clearly structured licensing framework.

Importantly, the effort required to obtain a PEL is manageable and predictable when addressed early and in line with the planned activities.

Rather than creating complexity, the PEL provides structure, clarity and trust – for authorities, partners and patients alike.

This is exactly where we at Swizzard support companies as they navigate regulatory and market entry requirements in Switzerland.

What questions do you have regarding Swiss entry requirements? Let’s start a conversation. 

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Reach out to us for expert guidance on your strategic planning. Together, we can ensure a smooth regulatory and market access process, accelerating the availability of rare disease therapies to patients in need.

Michael Zürcher, Owner & CEO

Bettina Schelbert, Commercial Director

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