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EU – Council adopts regulation introducing SPC stockpiling / export exception – UPDATE

12 Jun 2019

*** UPDATE ***

As expected, it was confirmed yesterday that the exception will enter into force on 1 July 2019. 


From the press release:

“The EU is taking measures to foster the competitiveness of EU producers of generic medicines and biosimilar products. The Council today adopted a regulation which introduces an exception to the protection granted to an original medicine by a supplementary protection certificate (SPC) for export purposes and/or for stockpiling.

“Thanks to the exception, EU-based manufacturers of generics and biosimilars will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the SPC either for the purpose of exporting to a non-EU market where protection has expired or never existed or (during the six months before the SPC expires) for the purpose of creating a stock that will be put on the EU market after the SPC has expired.”

The regulation is expected to enter into force by 1 July 2019.

The full press release can be read here.