Cancelling a marketing authorisation or registration and sunset clause

A marketing authorisation or registration can expire for many reasons:

  • The holder of a marketing authorisation or registration can cancel the marketing authorisation or registration by submitting a notice to Fimea.
  • If a preparation has not been on the market for three years, the marketing authorisation will expire pursuant to the Medicines Act (395/87), section 29, subsection 3, paragraph 3 (Sunset clause).
  • A new granted marketing authorisation or registration is usually valid for 5 years. A marketing authorisation or registration expires, if the holder does not submit a renewal application in time.