The Regulation (EU) No 2019/933, published in the Official Journal of the European Union on June 11, 2019, will enter into force on July 1st, 2019.

However, safeguards should apply in relation to the exception in order to increase transparency, to help the holder of an SPC enforce its protection in the Union and check compliance with the conditions set out in the Regulation, and to reduce the risk of illicit diversion onto the Union market during the term of an SPC. The producer, in particular must notify the competent authority in the Member State in which the product is to be made, using the so-called “standard form of notification” attached to the Regulation, and inform the SPC holder of all information listed in the form, no later than three months before the start date of manufacture in that Member State.

The new provisions will apply to SPCs applied for on or after 1 July 2019. They will also apply to SPCs applied for before 1 July 2019 which take effect on or after that date. The new provisions will, in any case, apply starting from 2 July 2022 only.

For any additional information please contact:
Debora Brambilla –