Legislation changes became into force since 1.01.2009
16 June 09
In addition to the state fee the applicant has to pay assessment fee in the amount of 6000 kroons upon receipt of invoice issued by the Agency.
Changes in the assessment duration: for phase II – IV studies the assessment period is within 30 days (for phase I studies it remains within 60 days and for gene therapy or somatic cell therapy, immunological medicinal products or medicinal products containing genetically modified organisms it remains within 90 days after receipt of the application and required documentation).
Assessment period for clinical trial amendment is within 30 days. Assessment fee for substantial amendment has to be paid in the amount of 1000 kroons upon receipt of invoice issued by the Agency. If the State Agency of Medicines has not notified the applicant of the refusal to grant authorisation or requested additional information within the specified term, authorisation is deemed to be granted.