X.C.5. Black symbol and explanatory statements

For medicinal products included in the list, the SmPC shall include the statement:

“This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.”,

preceded by an inverted equilateral black triangle (Implementing Regulation (EU) No 198/2013). A similar statement will also be included in the package leaflet. Once the medicinal product is included or removed from the list, the marketing authorisation holder shall update the SmPC and the package leaflet to include or remove, as appropriate, the black symbol, the statement, and the standardised explanatory statement.

If the decision to include or remove a medicinal product from the list is done during the assessment of a regulatory procedure (e.g. marketing authorisation application, extension of indication, renewal) the SmPC and the package leaflet should be updated before finalisation of the procedure in order to include or remove the black triangle symbol and explanatory statement from the product information.

If the decision to include or remove a medicinal product from the list is done outside a regulatory procedure, then the marketing authorisation holder is requested to subsequently submit a variation to update the product information of that product accordingly.