PRAC Signal Recommendations

The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessment of signals and issuing subsequent recommendations. The PRAC recommendation may include one or a combination of conclusions, for example:

  • No need for further evaluation or action at present;
  • Need for additional information (ie. the MAH should submit additional data or address in the next PSUR);
  • Need for regulatory action (ie. the product information and/or risk management plan should be updated through a variation).

Every month an overview of signals discussed at PRAC is published on the EMA website and includes PRAC recommendations for centrally and nationally authorised medicines. Marketing authorisation holders should monitor PRAC recommendations published on the website and should take action accordingly. 

HPRA currently contacts MAHs concerned if there is a recommendation to submit a variation to update the product information (and/or risk management plan) for one or more of their medicinal products. However, MAHs should note that they have a legal obligation to ensure that their product information is kept up to date with the PRAC recommendations, in line with article 16(3) of Regulation (EC) No 726/2004 and article 23(3) of Directive 2001/83/EC and are expected to submit the variation according to the timeline specified in the PRAC recommendation. The specified timeline is usually calculated from either the date of direct communication by HPRA or the date of publication of the PRAC recommendation, (i.e. after the following CHMP/CMDh meetings), whichever comes first.