EMA - Outcomes of imposed non-interventional post-authorisation safety studies
Year: 2024
Type: other
Abstract: 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...
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12f6z
Author: Vroby
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W6955673622
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