On 11 June 2019, the EU published Regulation (EU) 2019/933, which amends Regulation (EC) 469/2009 concerning supplementary protection certificates (SPCs).
The amendments to the SPC regulation will permit third parties to manufacture a medicinal product protected by an SPC for the exclusive purpose of export to countries outside the EU. The amendments will also permit third parties to stockpile such a medicinal product up to six months prior to SPC expiry, for the purpose of day one release in the EU after expiry of the SPC.
The amendments will enter into force on 1 July 2019. The following transitional provisions will apply.
In view of the above, it is advisable where possible to file new SPC applications prior to 1 July 2019.