VI.C.3. Submission time frames of ICSRs in EU

The general rules in relation to the submission of initial and follow-up reports, including those for defining the clock start are detailed in VI.B.7.

According to Article 107(3) and 107a(4) of Directive 2001/83/EC,

• serious valid ICSRs shall be submitted by the competent authority in a Member State or by the marketing authorisation holder within 15 days from the date of receipt of the reports;
• non-serious valid ICSRs shall be submitted by the competent authority in a Member State or by the marketing authorisation holder within 90 days from the date of receipt of the reports.

ICH-E2B provides a mechanism to the sender to indicate whether a valid ICSR fulfils the local regulatory requirements for submission to the EudraVigilance database within the 15 or 90-day time frame. In line with ICH-E2B the following applies for the serious and non-serious ICSRs which need to be submitted in the EU based on the modalities detailed in VI.C.4.: