The EU Commission has published a revision of the Guidance on Investigational Medicinal Products (IMPs) and Non investigational Medicinal Products (NIMPs), which had been published in 2007, completing the detailed guidance CT-1. The main change relates to point 3.3 and the additional annex 2 setting out documentation requirements for NIMPs in the application dossier.
In 3.3., it is pointed out that documentation requirements in the application dossier for IMPs also apply to NIMPs. However, depending on the knowledge of the NIMP, documentation can be reduced to a so called 'simplified dossier' described in detail in Annex 2 of the document. To determine the required data, a risk-based approach needs to be applied.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)