SPC Manufacturing Waiver Regulation Will Enter Into Force on 1 July 2019
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.
- An SPC granted and in force prior to 1 July 2019: the waiver will not apply.
- An SPC granted on an SPC application filed on or after 1 July 2019: the waiver applies.
- An SPC granted on an SPC application filed prior to 1 July 2019, but where the SPC is not in force until on or after 1 July 2019: the waiver only applies from 2 July 2022.
In view of the above, it is advisable where possible to file new SPC applications prior to 1 July 2019.
If you have any questions please contact your usual J A Kemp adviser.
For further information, please see our briefing on the manufacturing waiver here.