An epicutaneous test – also known as a patch test – is a skin test that doctors can use to diagnose a contact allergy. The test involves the application of various allergy triggers (allergens) to the patient's skin in a test patch (epicutaneous = "on the skin"). After a certain amount of time, the doctor examines whether the application has led to allergic contact eczema on the skin in the test area.
Updated: 26.04.2024
Epicutaneous test products are diagnostic allergen products that are subject to authorisation according to European Directive 2001/83/EC. The authorisation of epicutaneous test products is regulated accordingly in Germany in accordance with section 25 of the Medicinal Products Act (Arzneimittelgesetz, AMG). In addition, there are epicutaneous test products still undergoing the authorisation process that are marketable within the framework of a transitional provision in accordance with section 141 sentence 4 of the AMG.
The regulatory authorisation process includes a detailed examination of the product and guarantees its quality, efficacy, and safety.
The Paul-Ehrlich-Institut offers publicly-accessible online overviews of authorised epicutaneous allergens as well as the epicutaneous allergens that are still undergoing the authorisation process, which are legally allowed to be placed on the market.
Updated: 26.04.2024
