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Industry Prepares For Advent Of SPC Manufacturing Waiver

 
• By Dave Wallace

As the generics and biosimilars industries prepare for the European SPC manufacturing waiver to come into effect on 1 July, Generics Bulletin traces the history of the mechanism from early industry lobbying efforts to its ultimate entry into force.

July
On 1 July The SPC Waiver Regulation Comes Into Effect • Source: Shutterstock

On 1 July, European Regulation 2019/933 enters into force, marking the end of a long journey for the generics and biosimilars industries in its pursuit of a waiver to allow manufacturing for export outside the European Union – as well as stockpiling for day-one launch within the EU – during the term of supplementary protection certificates.

Amending the European SPC Regulation 469/2009, the waiver Regulation is the culmination of more than a decade of lobbying efforts...

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