European Medicines Agency updates product-information template to label medicines subject to additional monitoring and encourage adverse-reaction reporting
As part of the implementation of the European Union (EU) pharmacovigilance legislation, the European Medicines Agency has updated the product-information template to allow easy identification of human medicines that are subject to additional monitoring and to encourage adverse-reaction reporting for all medicines.
This template is used by companies to create the product information for the medicines they market in the EU. An implementation plan, also published today, outlines the regulatory process and timeline the companies need to follow to comply with these new requirements.
The revised template includes a black inverted triangle, which all medicines subject to additional monitoring will have to include in their summary of product characteristics and package leaflet from September 2013. This symbol, which was recommended by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC) and adopted by the European Commission on 7 March 2013, will be followed by a statement and a standardised sentence explaining that the medicine is under additional monitoring.
The Agency will be publishing a list of medicines that will need to carry this symbol within the next few months. It will include:
- all medicines that contain a new active substance and all biological medicines authorised after 1 January 2011;
- medicines for which certain additional information is required after authorisation;
- medicines subject to conditions or restrictions on their safe and effective use.
The updated product information also encourages patients and healthcare professionals to report adverse reactions and specify the different ways to report. This text will appear in the summary of product characteristics and package leaflet of all medicines from September as well.
This revision was finalised after consulting members of the Agency’s Patients’ and Consumers’ Working Party and Healthcare Professionals’ Working Group, as well as medicines regulatory authorities in EU Member States, pharmaceutical-industry associations, contract research organisations specialised in user testing, communication experts and academia. A public consultation was also conducted in 2012 on the proposed phasing-in arrangements by the European Commission.
In addition to changes related to the new pharmacovigilance legislation, this revision also includes additional guidance on how to complete the template as well as improvements in some language versions.
The updated templates are available in all official EU languages, as well as Icelandic, Norwegian and Croatian, together with an implementation plan. Versions of the templates showing the latest updates as tracked changes are also available.
- Product-information templates
- Croatian pre-accession linguistic check
- 2010 pharmacovigilance legislation
- Public consultation open on phasing-in of 'black symbol' for medicines under additional monitoring (22/11/2012)
- Pharmaceuticals: New symbol to identify medicines undergoing additional monitoring