EMA - Outcomes of imposed non-interventional post-authorisation safety studies

The European Medicines Agency (EMA) publishes the outcomes of final study results of imposed non-interventional post-authorisation safety studies (PASS) for medicines authorised in the European Union (EU). The rules on submitting results for imposed non-interventional PASS fall under Art 107q of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use. A PASS is a study carried out after a medicin...