Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 22

An adverse reaction, the nature, severity or outcome of which is not consistent with the Summary of Product Characteristics (SmPC) (Article 1(13) of Directive 2001/83/EC67). This includes class-related reactions which are mentioned in the SmPC but which are not specifically described as occurring with this product. For products authorized nationally, the relevant SmPC is that approved by the Competent Authority in the Member State to whom the reaction is being reported (often in the local language). For centrally authorized products, the relevant SmPC is the SmPC authorized by the European Commission. During the time period between a CHMP Opinion in favor of granting a marketing authorization and the Commission Decision to grant a marketing authorization, the relevant SmPC is the SmPC annexed to the CHMP Opinion (EMA GVP Module Annex I definitions).

These adverse reactions, when the SmPC is used as the reference document, are referred to as unlabeled. This is quite different from unlisted (see below).

Note: For products registered in the EU, the EU SmPC is the single document to consider, even for clinical trial ICSRs; the investigator brochure is the reference document for clinical trial ICSRs, but only if the product is not registered.