Therapeutic allergen prescription

Ordinance on the extension of the regulations on the authorisation of medicinal products to therapeutic allergens produced for individual persons on the basis of a prescription and on procedural regulations for state batch testing (Therapeutic Allergen Ordinance)

Therapeutic allergens are used in a so-called "Specific Immunotherapy (SI)", which can be used to treat certain allergic diseases. A distinction is made between drugs for injection (subcutaneous application) and drugs for oral administration (sublingual application). The following allergen groups are called therapeutic allergens:

Subcutaneously applied therapeutic allergens

• grass / cereal / herb pollen
• tree pollen
• House dust mites
• Insect venoms

Sublingually applied therapeutic allergens

• grass / cereal / herb pollen
• tree pollen
• House dust mites

For specific immunotherapy (SI) as a causal allergy therapy, there are not only approved finished drugs manufactured in advance in batches available in Germany, but also individual prescriptions (IR) that are exempt from the obligation to obtain marketing authorization. When the Therapeutic Allergen Ordinance (TAV) came into force on 14.11.2008, this exemption was limited to therapeutic allergens for the treatment of rare allergies. IR that contain at least one of the allergens listed in the appendix of the TAV had to be notified to the Paul-Ehrlich-Institut by 14.05.2009 in order to maintain their marketability. Since October 2009, the bulks from which the IR are produced have been subject to state batch testing.

On the basis of Section 35 (1) No. 2 and (2) and Section 80 Sentence 1 Nos. 1 and 2 of the German Medicines Act (Arzneimittelgesetz) as amended by the announcement of the Act of 12 December 2005 (Federal Law Gazette I p. 3394), the Federal Ministry of Health, in agreement with the Federal Ministry of Economics and Technology, decrees:

§ Section 1 Obligation to obtain a marketing authorisation

The provisions of the Medicines Act on the authorisation of medicinal products are extended to therapeutic allergens which are produced for individual persons on the basis of a prescription from prefabricated containers and contain one or more of the allergens listed in the Annex.

§ 2 State batch test

§ Section 32 of the German Medicines Act is applied to therapeutic allergens according to Section 1 with the proviso that the subject of the state batch test and release is the batch of the prefabricated container immediately before the therapeutic allergens are filled or mixed from it.

§ 3 Defines a transitional provision for various therapeutic allergens according to § 1 which are already being produced when this Ordinance comes into force and for which no approval has been applied for.

Information from the Paul Ehrlich Institute: https://www.pei.de/DE/arzneimittel/allergene/therapie-allergene/therapie-allergene-node.html