14/05/2019 (Agence Europe) – On Tuesday 14 May, the Council of the EU adopted the Regulation on a system of exemption from the protection granted to a medicinal product by a supplementary protection certificate (SPC) for export or storage purposes. The exception applies when generics or biosimilars are produced exclusively for export to non-Member States where the protection of the original medicinal product does not exist or has expired or for storage purposes during the last 6 months of validity of the SPC (see EUROPE 12194/4). The Regulation will only apply to SPCs that have been requested on the date of entry into force, 3 years after its entry into force. Thereafter, the Regulation will also apply to SPCs that were requested before its entry into force, but which took effect after its entry into force. To consult the text: https://bit.ly/2VAMcSr (PH)