On 1 July 2019, EU Regulation 2019/933 entered into force. The Regulation introduced manufacturing waivers for exporting and stockpiling active pharmaceutical ingredients and medicinal products. If ...

The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim ...

Laura Whiting and Alexandra Morgan of Freshfields Bruckhaus Deringer consider the reasons behind the adoption of the new SPC Manufacturing Waiver Regulation and reflect on whether the message sent out ...

Cristina Biggi of Bugnion examines the introduction of the new SPC manufacturing waiver, including the process that led to its creation and the amendments it makes to the SPC regulation Supplementary ...

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