Biosimilars in accordance with Article 13 TPA

Can biosimilars that are to be authorised in accordance with Article 13 TPA be submitted together with the Opinion?

The rule described in the appendix of guidance document Guidance Article 13 TPA final  under point 11.2, namely that initial authorisation applications sent to Swissmedic based on authorisations issued in line with the EU Centralised Procedure (CP) can be made at the time of the CHMP Opinion and that the EC decision can be passed on as soon as it is available, also applies to biosimilars.

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Any questions?
I would be delighted to answer them.

Dr. Katharina Oehler
Scientific and Managing Director

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