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The
Guidance on Investigational Medicinal Products (IMPs) and other medicinal
products used in Clinical Trials has been added to Chapter V (Additional
Information of EUDRALEX Volume 10 - Clinical Trials.
As the European Commission points out in the document's
introduction, it "intends to clarify and provide additional guidance on the
definition of investigational medicinal products and to provide specific
guidance about the use of non-investigational medicinal products, in
accordance with the applicable EU legislation.
The Guidance complements the "Detailed guidance for the
request for authorisation of a clinical trial on a medicinal product for
human use to the competent authorities, notification of substantial
amendments and declaration of the end of the trial"1 and the "Detailed
guidance on the application format and documentation to be submitted in an
application for an Ethics Committee opinion on the clinical trial on
medicinal products for human use".
Besides clarification on how an IMP is defined, the
document also gives general guidance on other medicinal products used in
clinical trials like for example concomitant or rescue/escape medication for
preventive, diagnostic or therapeutic reasons and/or to ensure that adequate
medical care is provided. Guidance is also given on medicinal products which
are normally used in clinical trials as non-investigational medicinal
products (NIMPs).
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