X.B.2. Communication and transparency

The additional monitoring status needs to be communicated to healthcare professionals and patients in such a way that it increases reporting of suspected adverse reactions without creating undue alarm. This can be achieved for example by highlighting the need to better characterise the safety profile of a new medicinal product by identifying additional risks but placing those potential risks in the context of the known benefits for this product. A publicly available list of medicinal products with additional monitoring status should be kept up to date by the Agency In addition, healthcare professionals and patients should be enabled to easily identify those products through their product labelling. The publication of the list together with appropriate communication should encourage healthcare professionals and patients to report all suspected adverse drug reactions for all medicinal products subject to additional monitoring.