Simplified authorisation of biologics

Under which circumstances is the simplified authorisation of biological products possible?

Biological active substances which are not classed as biotechnology-derived active substances and which are regarded as a known active substance in Switzerland are classed as “na-bws” [new application - known active substance]. Such biologics can be authorised in accordance with Article 13 TPA.  In so doing, for example, it is possible to refer to a DCP as a reference procedure (with the relevant reference authority), if this procedure is complete and has resulted in a positive decision. If this biological active substance has been authorised in a medicinal product for at least 10 years in a Member State of the EU or EFTA and is comparable in terms of indication, dosage and method of administration, the biologic can also be authorised in accordance with Article 14, para. 1, letter abis TPA, if applicable.

Your contact

Any questions?
I would be delighted to answer them.

Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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