2. Safety communication - content

Safety communication - content

When disseminating safety information, the EMA proposes that the following specific information accompanies the message:

  • the reason for initiating safety communication clearly explained to the target audience;
  • any recommendations to healthcare professionals and patients on how to deal with a safety concern;
  • when applicable, a statement on the agreement between the marketing authorisation holder and the competent authority on the safety information provided;
  • information on any proposed change to the product information (e.g., the summary of product characteristics (SmPC) or package leaflet (PL));
  • a list of literature references or where more detailed information can be found;
  • a reminder of the need to report suspected adverse reactions in accordance with national spontaneous reporting systems (where relevant).

The EMA guidelines stress that the safety information ‘shall not be misleading’ and ‘shall be presented objectively’. Furthermore, safety information ‘should not include any material or statement which might constitute advertising’, as mentioned in the European Directive 2001/83 (https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-1_en) in the ‘Advertising’ article (Article 86).