Amendment of the SPC Regulation regarding "export manufacturing waiver" has entered into force
The awaited amendment of the SPC Regulation regarding "export manufacturing waiver" has entered into force with effect from 1 July this year.
From 1 July it has thus become possible under specific and limited circumstances, while a SPC (Supplementary Protection Certificate) is in force, to manufacture and store generics and biosimilars if it is intended exclusively for export to third countries, in which the SPC-protection has expired or never existed, or for the purpose of entering the market immediately after expiry of the SPC ("day-one entry").
In connection with the original proposal for the amendment, Plesner published a Plesner Insight on the legal effects of the proposal, which can be read here (in Danish).
Read the amendment of the SPC Regulation here