XV.B.4. Content of safety communication

The information in the safety communication shall not be misleading and shall be presented objectively [DIR Art 106a(1)]. Safety information should not include any material or statement which might constitute advertising within the scope of Title VIII of Directive 2001/83/EC.

Therefore, taking into account the above provisions and the principles in XV.B.2., safety communication should contain:

• important new information on any authorised medicinal product which has an impact on the medicine’s risk-benefit balance under any conditions of use;
• 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));
• any additional information about the use of the medicine or other data that may be relevant for tailoring the message to the targeted audience;
• a list of literature references, when relevant or a reference to where more detailed information can be found, and any other background information considered relevant;
• where relevant, a reminder of the need to report suspected adverse reactions in accordance with national spontaneous reporting systems.