[The therapy allergens ordinance ("Therapieallergene-Verordnung"). Background and effects]

Medicinal products for specific immunotherapy as causal treatment of allergies exist in Germany as authorized medicinal products manufactured batchwise in advance and as named patient products (NPPs) which are exempted from the authorization procedure. With the therapy allergens ordinance ("Therapieallergene-Verordnung (TAV)") which has been in effect since 14 November 2008, this exemption was restricted to therapy allergens indicated for the treatment of rare allergies. NPPs containing at least one of the therapy allergens listed in the annex of the TAV had to be notified to the Paul-Ehrlich-Institut (PEI) by 14 May 2009 to retain their marketability. It had to be stated whether applications for marketing authorization will be submitted for the respective NPPs or if they will be sold off by 14 November 2011. The bulks which are used for manufacturing of the NPPs have been subject to official batch release by PEI since October 2009. Nearly 7,000 NPPs of 10 pharmaceutical entrepreneurs were notified. Marketing authorization applications were submitted for 123 NPPs. This illustrates that, although there are authorized therapy allergens available for all allergens listed in the annex of the TAV, a large number of NPPs with unknown quality, safety, and efficacy have been marketed.