![]() ![]() In any case, the protocol shall include a statement on the authorization status of AMPs and the use in accordance with the terms of their marketing authorizations. The price of authorized auxiliary medicinal products should not be considered as having an effect on the availability of such medicinal products. However, it also states that where no authorized auxiliary medicinal products are available in the EU or where the sponsor cannot reasonably be expected to use an authorized AMP, a justification for use of an unauthorized AMP should be included in the protocol. Obviously, there is a preference for the use of authorized AMP and as a general rule the Regulation requires the use of authorized AMP. In all circumstances, the clinical trial protocol must include a description of these products and refer to the characteristics of an AMP. Auxiliary medicinal products should not include any medication unrelated to the clinical trial and not relevant for the design of the clinical trial (concomitant medication). Note that, challenge agents are typically considered as IMP, though there have been discussions and different decisions in the past. background medication, rescue medication, diagnostics etc. In summary, AMPs are related to the design of a clinical trial, but are not considered as Investigational Medicinal Product (IMP), e.g. Authorized auxiliary medicinal products: A medicinal product authorized in accordance with Regulation (EC) No 726/2004, or in any Member State concerned in accordance with Directive 2001/83/EC, irrespective of changes to the labeling of the medicinal product, which is used as an auxiliary medicinal product. ![]() ![]() The following definitions are included in the Regulation: Auxiliary medicinal products: A medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product. Additionally, the Regulation differentiates between authorized and unauthorized AMP (in the EU), in a similar way to Investigational Medicinal Products (IMPs). For example, the term “Auxiliary Medicinal Products” or AMP, which basically replaces the traditionally used term of Non-Investigational Medicinal Product (NIMP). The Regulation introduces new terms which Sponsors will need to incorporate into their processes and documentation as required. In addition to significant changes related to the application process, the Regulation contains rules for conducting clinical trials including the management of a clinical trial's drug supply. 536/2014 was introduced on 16 April 2014 and is expected to be implemented in Europe by October 2018 at the latest. ![]()
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