Swissmedic Establishment Licence for an Unlimited Period

Save time, effort and money and get an inspection-ready QMS

"Companies that manufacture or distribute medicinal or transplant products in Switzerland (manufacturing, wholesale, import, export and trade in foreign countries) require an establishment licence.
In most cases, establishment licences issued from 1 January 2019 under the new legislation are valid for an unlimited period."

This is what you read at Swissmedic since 1 January 2019.

The usual, regular application for an extension is eliminated with the unlimited establishment licence. That reduces the bureaucratic, formal effort and saves money over the long term. Ongoing business activities are also assured!
But the application under the new law also means the initial formal effort is greater. Extensive communication with the public authority may be required. The correct, objective and experienced approach from the outset saves time here as well.


“Swissmedic issues this licence on the basis of a successful inspection or other evaluation.“

But how well is the company prepared for an inspection?
Is the quality management system inspection-ready?
Are the processes aligned with the new regulations?
Are all SOPs up to date? Is the staff well prepared?
Is there an existing list of defects? 


„Suppliers and customers must therefore always inspect their business partners’ establishment licence.“

What about the auditing of business partners?
Preparing for the application is an opportunity to make the QMS efficient and inspection-ready. What are possible weaknesses, where can potential savings be realised? A Gap Analysis identifies starting points quickly and efficiently. 


gempex Switzerland provides support as an internationally active GMP expert. The GMP experts are intimately familiar with the requirements under Swiss law and their implementation in practical quality life cycle management for highly regulated production. They make GMP projects a success! 

The focus is on consultancy and project implementation for GMP compliance, commissioning & qualification, IT validation and GMP routines. From the initial analysis to the development and realisation of concepts to expert leasing. Informed and pragmatic. 

Customers include leading companies in the chemical and pharmaceutical industries, biotechnology, cosmetics and medical devices as well as their suppliers. 


Ralf Gengenbach, Managing Director gempex, is happy to answer technical questions in this field.
Call +41 62 86990-20 to make an appointment.