Guideline for registration of allergenic substances

The EU guideline on Allergen products: Production and quality issues lays down the quality recommendations for allergen products of biological origin, including allergen extracts derived from natural source material and allergens produced through recombinant DNA technology, used for specific immunotherapy or in vivo diagnosis of immunoglobulin E (IgE)-mediated allergic.

This guideline has been adopted by the Australian Pesticides and Veterinary medicines Authority (APVMA) as guidance for registration of veterinary allergenic products and is to be used in conjunction with the APVMA’s Part 8 Efficacy and Safety Guidelines.

Import permit

A copy of the current Department of Agriculture, Fisheries and Forestry import permit should be included with applications involving imported biological components.


Label warnings relating to concurrent immunosuppressive therapy should be included in the 'Restraint' section of the leaflet. You should review the Veterinary Labelling Code for further guidance on labels.

Was this page helpful?

Your feedback will be submitted to the APVMA anonymously. If you require a response, please contact us.