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3 articles available
3 articles available
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…
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…
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…