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Table 2 National definitions of an investigational medicinal product.

From: Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Countries

Definition of investigational medicinal product

Austria

The definition is that of the Directive 2001/20/EC.

Denmark, France, Hungary, Ireland, Italy, Spain, Sweden, and the UK

The investigational medicinal product is the study drug and the comparator including the placebo or active drug.

Denmark

The rescue drug and all background treatment that directly influences the main efficacy outcomes of the study are also considered investigational medicinal products.

France

The background treatment is also considered an investigational medicinal product if collecting information on it is one of the objectives of the study.

Germany

The investigational medicinal product is a pharmaceutical form of active pharmaceutical substances and placebos, that is tested in a clinical trial on humans or used as a comparator or that is applied to induce specific reactions in humans. This includes EU authorised drugs if they are investigated within a clinical trial, EU authorised drugs if they will be used as comparator, and EU non-authorised drugs.

Italy

The drugs which are not the direct subject of the experimental design, but their use is considered in the protocol, are also considered investigational medicinal products:

1. Drugs with market authorisation, used according to the indications, included in the protocol as needed to the success of the trial, such as drugs to prevent or treat side effects of the investigational medicinal product.

2. Drugs with market authorisation, used outside the approved indication.

3. Drugs without market authorisation, but with market authorisation in other countries of the EC, used within or without the approved indication.

4. Challenge agents, i.e., drugs that are used to induce physiological reactions needed to evaluate the effect of the investigational medicinal product.

The rescue drug, and background treatments are not investigational medicinal products.

Spain

Background treatment, the rescue drug, the challenge agent and the medicine used to assess the primary endpoint, if not authorised in any EU country, or when authorised and used for non-authorised indications are also considered investigational medicinal product.

Sweden

The drugs used to assess outcome measures are also considered investigational medicinal products. This includes already approved drugs, which have been formulated differently or are used outside their approved indication, or used to gain additional knowledge about the approved indication.