Reduction in Fees for Test Allergens for the Detection of Rare Allergies

From the Paul-Ehrlich-Institut’s the point of view, the availability of test allergens for diagnosing allergies targeted against rare allergy-triggering substances is of public interest. In the past few years, marketing authorisation holders renounced various marketing authorisations of test allergens for rare allergens. Since allergens for diagnosing less frequently occurring allergies are seldom used, it is understood that manufacturers cannot achieve an adequate economic benefit by marketing these products. Thus, for all test allergens based on allergy triggering substances not included in the so-called Therapy Allergen Regulation (Therapieallergene-Verordnung, TAV), we can assume that these are only of low economic benefit. To improve the availability of test allergens for rare allergies, the Paul-Ehrlich-Institut has, as per to date, reduced the fees for all official actions in connection with these medicines to a quarter, if the manufacturing holder applies for this.

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