X.B.1. Principles for assigning additional monitoring status to a medicinal product

All medicines are authorised on the basis that the benefit of treatment is considered to outweigh the potential risks. To come to this conclusion for a marketing authorisation, data from clinical trials conducted during the development of a medicine are assessed. However, adverse reactions which occur rarely or after a long time may become apparent only once the product is used in a wider population and/or after long term use. In addition, the benefits and risks of a medicine may have been evaluated in conditions which may differ from those in everyday medical practice, e.g. clinical trials might exclude certain types of patients with multiple co-morbidities or concomitant medications. Therefore, after a medicine is placed on the market, its use in the wider population requires continuous monitoring. Marketing authorisation holders and competent authorities continuously monitor medicinal products for any information that becomes available and assess whether it impacts on the benefit-risk profile of the medicinal product. However, for certain medicinal products enhanced postauthorisation data collection is needed to ensure that any new safety hazards are identified as promptly as possible and that appropriate action can be initiated immediately. Therefore, in order to strengthen the monitoring of certain medicinal products and in particular to encourage the spontaneous reporting of ADRs, the concept of additional monitoring has been introduced.

Additional monitoring status can be assigned to a medicinal product at the time of granting a marketing authorisation or in some cases at later stages of the product life cycle for a medicinal product for which a new safety concern has been identified. The additional monitoring status is particularly important when granting marketing authorisation for medicinal products containing a new active substance and for all biological medicinal products, which are priorities for pharmacovigilance. Competent authorities may also require additional monitoring status for a medicinal product which is subject to specific obligations e.g. the conduct of a Post-Authorisation Safety Study (PASS) or restrictions with regards to the safe and effective use of the medicinal product.