Changes to the guidance document Authorisation of human medicinal products under Art. 13 TPA HMV4

06.05.2020

Art. 13 TPA can be applied for minor variations (types IA / IAIN and IB) as long as these are processed in an Assessment Report by the foreign reference authority and do not contradict the legal requirements in Switzerland.

Swissmedic has accordingly updated the guidance document Authorisation of human medicinal products under Art. 13 TPA.