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Supplementary protection certificate

Definition : Supplementary protection certificate

The Supplementary Protection Certificate (SPC), replaces the Patent upon its expiry in order to extend the protection of the active substance(s) for medicinal products and plant protection products for a period of 5 years. The SPC thus compensates for the impossibility of exploiting it before obtaining Marketing Authorisation (MA).

Supplementary protection certificates for medicinal products are governed by Regulation (EC) No 429/2009 of the European Parliament and of the Council of 12 December 2006, as amended by Regulation (EU) No 2019/933 of 20 May 2019. This regulation created an exception allowing generic or similar biological medicinal products to be manufactured for export to countries outside the EU where the product has never been or is no longer protected.