Supplementary Protection Certificates - The Waiver Regulation
Jane Lambert On 1 July 2019 Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (Text with EEA relevance.) OJ L 153, 11.6.2019, p. 1–10 came into force. It consists of 30 paragraphs of recitals but only 2 articles. Art 1 amends Regulation (EC) No 469/2009 of the Europea Parliament and of the Council f 6 May 2009concerning the supplementary protection certificate for medicinal products OJ 16.6.2009 L 152 p1-9 so as to enable generic and biosimilar manufacturers to make products that are protected by supplementary protection certificates ("SPC") for export to third countries or to stockpile them for distribution from the moment the SPC expires. Art 2 provided for Regulation 2019/933 to enter into force on the 20th day following its publication in the Official Journal. What is an SPC? An SPC...