Article 21: Signal management process
1. The signal management process shall include the following activities: signal detection, signal validation, signal confirmation, signal analysis and prioritisation, signal assessment, and recommendation for action.
For the purposes of this Article, ‘signal validation’ means the process of evaluating the data supporting the detected signal in order to verify that the available documentation contains sufficient evidence demonstrating the existence of a new potentially causal association, or a new aspect of a known association, and therefore justifies further analysis of the signal.
2. Where a marketing authorisation holder detects a new signal when monitoring the Eudravigilance database, it shall validate it and shall forthwith inform the Agency and national competent authorities.
3. Where it is considered that a validated signal requires further analysis, it shall be confirmed as soon as possible and no later than 30 days from its receipt as follows:
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(a) |
where the signal concerns a product authorised in accordance with Directive 2001/83/EC, it shall be confirmed by the competent authority of a Member State in which the medicinal product is marketed or of any lead Member State or co-leader appointed in accordance with Article 22(1); |
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(b) |
where the signal concerns a product authorised in accordance with Regulation (EC) No 726/2004, it shall be confirmed by the Agency in collaboration with the Member States. |
When analysing the validated signal, national competent authorities and the Agency may take into account other information available on the medicinal product.
Where the validity of the signal is not confirmed, special attention shall be paid to non-confirmed signals concerning a medicinal product where those signals are subsequently followed by new signals concerning the same medicinal product.
4. Without prejudice to paragraphs 2 and 3, national competent authorities and the Agency shall validate and confirm any signal that they have detected during their continuous monitoring of the Eudravigilance database.
5. Any confirmed signal shall be entered in the tracking system administered by the Agency and shall be transmitted to the Pharmacovigilance Risk Assessment Committee for the initial analysis and prioritisation of signals in accordance with Article 107h(2) of Directive 2001/83/EC and Article 28a(2) of Regulation (EC) No 726/2004.
6. The Agency shall inform forthwith the marketing authorisation holder(s) concerned of the conclusions of the Pharmacovigilance Risk Assessment Committee of the assessment of any confirmed signal.