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SPC Manufacturing Waiver: Good For Generics, But Legal Questions Remain

This article was originally published in SRA

Executive Summary

The European Parliament's backing for a waiver that would allow generics firms in the EU to produce generic and biosimilar drugs for export to non-EU countries during the originator product's EU supplementary protection certificate (SPC) period may have been welcomed by the generics industry, but it poses a set of legal questions that the European Commission will have to deal with before a waiver can be implemented.

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