Companies that intend to manufacture and/or distribute medicinal products or TpP/GT/GMO (trans-plant products/gene therapy products/genetically modified organisms) in Switzerland (manufacturing, wholesale, import, export and trade in foreign countries) must obtain an establishment licence from Swissmedic.
Swissmedic issues this licence on the basis of a successful inspection or other evaluation pursuing the Therapeutic Products Act (TPA, SR 812.21) and the Medicinal Products Licensing Ordinance (MPLO, SR 812.212.1).
To obtain such license the company must operate a quality assurance system that ensures the GMP-compliant manufacture and/or the GDP-compliant distribution of medicinal products and nominate a Responsible Person (Fachtechnisch verantwortliche Person (FVP) – equivalent to the Qualified Person in the EU).
