Calculate SPC duration = marketing authorisation date − filing date − 5 years, capped at 5 years (plus 6-month paediatric extension). EU Regulation 469/2009 framework for medicinal product SPCs.
⚖ For informational purposes only. Not legal advice. Consult a licensed attorney for your specific situation.
Enter the values for the scenario you are assessing. Calculate SPC duration = marketing authorisation date − filing date − 5 years, capped at 5 years (plus 6-month paediatric extension). EU Regulation 469/2009 framework for medicinal product SPCs. Use the spc duration result to inform your calculation.