Every day counts: why pharmaceutical companies in the EU need to make sure they get the right SPC term
06 October 2011
SCRIP Regulatory Affairs October 2011, 6-7
Author: Mike Snodin
This article appeared in the October 2011 edition of SCRIP Regulatory Affairs. It argues that the standard practice of many national patent offices is incorrect, and that human medicinal products that are first authorised by the “centralised” (European Commission / European Medicines Agency) procedure should instead have SPC term calculated using the date of notification to the applicant of the European Commission's decision to issue a marketing authorisation. For some medicinal products this could lead to slightly longer (typically 2 to 4 days longer) SPC term.