Guidance Document Application Establishment Licence for Medicinal Products or TpP/GT/GMO

Swissmedic Application Process for Establishment Licenses

This document outlines the application process and requirements for companies seeking to manufacture and distribute medicinal products or Transplant Products (TP), Gene Therapy Products (GT), Genetically Modified Organisms (GMO), and obtain an establishment license from Swissmedic. Key points include:

Reference Numbers and Fees: Details on fees, reference numbers, and conditions to be met for both initial issues and changes to establishment licenses. 

• Updated Information:
•  New guidance on the UID number. 
•  Requirements for cell procurement and handling for CAR-T cell products. 
•  Addition of UID register reference for companies not registered in the trade registry.

Submission Procedures:
Basic form and supplementary sheets required for medicinal products, TP/GT/GMO, and changes in name or domicile for the establishment license. 

• Specific codes and requirements for manufacturing, issuing manufacturing orders, and distribution of medicinal products, TP/GT/GMO, and medical gases.
• Wholesale Trading License: Companies trading products abroad or issuing contract manufacturing orders must obtain a wholesale trading license.

This document provides comprehensive guidelines to streamline the process for obtaining and updating establishment licenses for companies in the pharmaceutical and biotech sectors.

Region:Switzerland

Source: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/bewilligungen/i-301/i-301.aa.05-A17d_gesuch_betriebsbewilligung.pdf.download.pdf/I-301.AA.05-A17d_Wegleitung_Gesuch_Betriebsbewilligung_Arzneimittel_TpP_GT_GVO.pdf