In April 2023, the European Commission (EC) published the pharmaceutical legislation package, including the proposal for a Pharmaceutical Directive[1] , and further proposals for regulations on SPCs[2]. Article 85 of the proposed Directive aims at providing an amended provision for the so-called Bolar exemption, currently codified in Article 10(6) of Directive 2001/83/EC. The initial EC proposal…
Just over 2 years after the SPC waiver Regulation (EU) 2019/933 (amending the Regulation (EC) No 469/2009) entered into force (1 July 2019), and only a few months after the end of the transitional provisions for application of the SPC waiver under Art. 5(10) of the Regulation (2 July 2022), I have decided to follow…
Regulation (EU) 2019/933, amending the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (hereinafter referred to as the Regulation) was published in the Official Journal of the European Union on 11th June 2019 and thus came into effect on 1st July 2019. The amended Regulation establishes the so-called “SPC waiver”, that excludes…
