Report from the Commission to the European Parliament and the Council on the National and European Medicines Agency Experience Regarding the List of Medicines for Human Use Subject to Additional Monitoring

On 15 November 2019 the European Commission published the report concerning the experience gained regarding Additional Monitoring

Regulation (EC) No 726/2004 and Directive 2001/83/EC provide the EU legal framework for pharmacovigilance for medicinal products for human use. The provisions on pharmacovigilance were amended in 2010 and 2012. As a result of the changes the tasks and responsibilities for all parties were outlined within a proactive and proportionate risk management system. The link between safety assessments and regulatory action, along with transparency, communication and patient involvement were strengthened. This report concerns the experience gained regarding ʻadditional monitoringʼ, a specific aspect of pharmacovigilance activities which was introduced through the revision of the legislation.

The Member States and the European Medicines Agency (EMA) collected information on the experience of the implementation of the additional monitoring of medicines through:

a. A survey to estimate patient and healthcare professional (HCP) awareness of the black symbol and the additional monitoring concept.

b. EMA’s experience with the use of the additional monitoring list and a study on whether the inclusion of products on the list had an effect on reporting of their ADRs.

c. A survey to understand Member States’ experience with additional monitoring.

A joint report of the Heads of Medicines Agencies (HMA) and EMA based on the above surveys and analysis forms the main basis of this report.

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