Advanced Therapy Medicinal Products, transplants and procedures

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Advanced Therapy Medicinal Products, transplants and procedures

Instructions and information sheets

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New forms for applications for discontinuation of an establishment licence for medicinal products must be used with immediate effect.

10.01.24

Companies wishing to discontinue their establishment licence for medicinal products or TPs/GTPs/GMOs must submit not only the form “Application for establishment licence – Basic form Medicinal products (incl. blood)” (I-301.AA.05-A02) or the form “Application for establishment licence – Basic form TPs/GTPs/GMOs” (I-301.AA.05-A18), but also the new form “Application for establishment licence – Discontinuation of establishment licence Medicinal products (incl. blood), or TPs/GTPs/GMOs” (I-301.AA.05-A33) as well as the requested information and documentary evidence related to the activities carried out by the company.

The new forms must be used effective immediately to submit applications for discontinuation of establishment licences.

https://www.swissmedic.ch/content/swissmedic/en/home/services/documents/transplant-products.html