Abstrakt

The Therapy Allergen Ordinance (TAO) aims to migrate allergen immunotherapy (AIT) products for the treatment of common allergies, which were previously marketed in Germany as named patient products (NPP), into authorized products if their quality, efficacy, and safety are adequately shown. The TAO applies to all NPP containing active ingredients based on the following allergen sources: house dust mites, bee venom, wasp venom, pollen from sweet grasses (excluding maize), birch, alder, or hazel. The last product-specific deadlines granted under the TAO for the submission of clinical data relevant to the marketing authorization process will expire in 2026. The subsequent final assessment of the updated marketing authorization application (MAA) is carried out by the competent authority, the Paul-Ehrlich-Institut. During this period of processing by the competent authority, the products remain marketable until the marketing authorization application has been decided on. Currently (as of 08.08.2025), 40 AIT products are still marketable under the transitional provisions of the TAO (10 preparations for the treatment of allergies to house dust mites, 10 against tree pollen allergies, 16 against grass pollen allergies and 4 mixed preparations containing non-homologous allergen groups). For 8 of these products, the pharmaceutical companies have initiated the withdrawal of MAA as of 01.10.2025 or 31.01.2026, respectively. Prior to the final assessment of the updated MAAs, the competent authority is unable to make any public statements as to whether the individual applications for the remaining 32 products under the transitional provision will be concluded positively with the granting of MA or MA rejection. With the rejection of a MA, the product-specific marketability ends immediately, i.e., there is no additional sell-off period for the TAV products concerned. If a marketing authorization is granted, the marketability of the specific product is sustained.

Autoreninformation

Autoren

• V. Mahler¹
• D. Hartenstein¹
• I. Lauer¹
• S. Vieths²
• C. Ruoff³
• J. Zimmer¹
• S. Kaul¹

Abteilungen

• ¹ Abteilung Allergologie, Paul-Ehrlich-Institut, Langen,
• ² Präsident des Paul Ehrlich-Instituts; Forschungsgruppe Molekulare Allergologie, Paul-Ehrlich-Institut, Langen,
• ³ Fachgebiet Rechtsangelegenheiten, Abteilung Sicherheit von biomedizinischen Arzneimitteln und Diagnostika, Paul-Ehrlich-Institut, Langen

Adresse

Prof. Dr. med. Vera Mahler
Abteilung Allergologie
Paul-Ehrlich-Institut
Paul-Ehrlich-Straße 51-59
63225 Langen
Email: [email protected]

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