Draft QRD Template

Updated QRD Template – EU Consultation until 17th August 2012. A revised human medicines QRD (Quality Review of Documents) template for Centralised products has been drafted which addresses the requirements outlined in the recently published Pharmacovigilance Legislation.

The draft template includes new wording to be added to the Summary of Product Characteristics (SmPC) and to the Patient Information Leaflet (PIL).

The main changes proposed are as follows:

  • For products subject to additional monitoring, the SmPC and PIL will now include the statement “This medicinal product is subject to additional monitoring”. This statement will be preceded by a black symbol which will be selected by the Commission following a recommendation by the Pharmacovigilance Risk Assessment Committee.
  • A statement in the SmPC requesting that healthcare professionals to report any suspected adverse reaction in accordance with the national spontaneous reporting system.
  • A statement in the PIL advising patients to communicate any suspected adverse reaction to his/her doctor, pharmacist, healthcare professional or directly to the national spontaneous reporting system.

The draft template is under consultation until the 17th August 2012 and comments from stakeholders are invited.  Comments should be presented as annotations to the QRD template and sent via email to QRD@ema.europa.eu by 17th August 2012.

The same changes will automatically be applied to the MR/DCP/Referrals QRD template in due course.

If you have any queries about the new template, or would like guidance on how to update your product information in line with it, please contact us.