Therapy Allergen Ordinance (TAO): The final stretch

Area of Science:

• Immunology
• Pharmacology
• Regulatory Affairs

Background:

• The Therapy Allergen Ordinance (TAO) in Germany facilitates the migration of allergen immunotherapy (AIT) products from named patient products (NPPs) to authorized market status.
• This ordinance specifically addresses AIT products for common allergies derived from house dust mites, bee venom, wasp venom, specific pollens (grass, birch, alder, hazel), and mixed allergen groups.

Purpose of the Study:

• To outline the regulatory pathway and current status of AIT products under the TAO.
• To inform stakeholders about upcoming deadlines and the implications for product marketability.

Main Methods:

• Review of the Therapy Allergen Ordinance (TAO) provisions.
• Analysis of the current market status of AIT products undergoing the marketing authorization process.
• Monitoring of withdrawal and approval timelines for AIT products.

Main Results:

• As of August 8, 2025, 40 AIT products remain marketable under TAO transitional provisions.
• Pharmaceutical companies have initiated withdrawals for 8 AIT products with deadlines in late 2025 and early 2026.
• The Paul-Ehrlich-Institut is assessing updated marketing authorization applications (MAAs), with decisions pending for the remaining 32 products.

Conclusions:

• The marketability of AIT products under the TAO is contingent upon successful marketing authorization.
• Rejection of an MAA results in immediate market withdrawal without a sell-off period.
• Successful MAA grants perpetuate product marketability, ensuring continued patient access to AIT treatments.