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Switzerland: Updated Application Documentation for Medicinal Product Establishment License Discontinuation (w.e.f 9 January 2024)

Updated: 2 hours ago

Generally, companies that intend to manufacture and/or distribute medicinal, transplant, gene therapy products, or genetically modified products in Switzerland are required to obtain an establishment license from Swissmedic. There are eligibility requirements that must be complied with by the companies.


There are three (3) types of application submission procedures related to the establishment license: Procedure for Initial Issue of the Establishment License, Procedure for Changes Application to the Establishment License, and Procedure for Discontinuation Application of the Establishment License.


On 9 January 2024, Swissmedic announced the additional form required “Application for Establishment License – Discontinuation of the Establishment License Medicinal Products (incl. blood)” to be submitted during the discontinuation application together with the “Application for Establishment License – Basic Form Medicinal Products (incl. blood)”, basic form, and supplementary documentation. Companies must ensure all the criteria stated in the form have been resolved properly with guaranteed quality and safety of the medicinal products in the market before the decision to discontinue the establishment license can be issued.


Supplementary documentation needed is related to medicinal products or TpP/GT/GMO, change of name, and Responsible Person multiple mandates. The authorized signatory or Responsible Person must sign all documentation.

 

Source: Swissmedic

 

Contact us at info@arqon.com for more information.

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