IX.C.5. Signal confirmation by the PRAC rapporteur or (lead) Member State

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IX.C.

Within 30 days of receipt of a signal validated by the Agency or a Member State, or a standalone signal notification from a marketing authorisation holder, the PRAC rapporteur or (lead) Member State, as applicable, should confirm or not the signal, i.e. decide whether or not it should undergo PRAC analysis and prioritisation (see IX.A.1.2.).

Standalone signal notifications from marketing authorisation holders concerning nationally authorised products with no lead Member State are allocated by the Agency to a Member State where the substance is authorised (see Figure IX.3.).

If a validated signal involves several rapporteurs or (lead) Member States, confirmation by one of them triggers analysis and prioritisation by the PRAC.

The Member State or rapporteur confirming a signal should make a proposal for further management of the signal in preparation for the analysis and prioritisation by the PRAC.

A Member State or rapporteur may decide not to confirm a validated signal if, for example:

  • it is already adequately handled through a different procedure (e.g. PSUR, variation) at the time confirmation is considered, including procedures for other medicinal products containing the same active substance (e.g. originator product);
  • the validated signal involves an adverse reaction that is already adequately reflected in the product information of other products authorised in the EU with the same active substance;
  • the signal has already been subject of review and the data that has arisen since this review does not provide substantial new evidence;
  • the available data does not warrant further analysis due to limited evidence or clinical relevance.

The justification for not confirming a signal should be communicated to the Agency and PRAC and is shared by the Agency with marketing authorisation holders (see Figures IX.3. and IX.4. in IX. Appendix 1).

More details on the confirmation process are provided in Figures IX.3. and IX.4. in IX. Appendix 1.