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EU adopts measures in support of generic pharmaceuticals producers

Met dank overgenomen van Roemeens voorzitterschap Europese Unie 1e helft 2019 (Roemeens voorzitterschap), gepubliceerd op dinsdag 14 mei 2019.

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 new regulation will enable generics manufacturers based within the EU to compete with non-EU manufacturers on equal terms. It will create high-value jobs and boost the availability of generic medicines in the EU.

Niculae BĂDĂLĂU, Romanian Minister of economy

More details here.


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