Europe – Recommendations on common regulatory approaches for allergen products

It is known that the authorisation status of allergen products in the Member States (MS) in the European Union (EU) is heterogeneous. Previous information provided from several MS revealed that allergen products, both for diagnosis and therapy, are authorised and distributed in these MS based on different legal backgrounds. This also became evident in relation to the integration of allergen products into the European Union reference dates (EURD) list and the corresponding requirement for the submission of Periodic Safety Update Reports (PSUR). The current heterogeneous authorisation status of allergen products leads to a situation in which unique, specific entries in the Article 57 database are
currently impossible.

In some MS, the majority of allergen products have historically been distributed in response to a bona fide unsolicited order without a marketing authorisation (MA) according to Article 5 of the Directive 2001/83/EC as a medicinal product for use by an individual patient (named patient product, NPP). While for new products a MA and a full dossier are required, for the majority of the NPPs there is no documentation or independent evaluation on quality, safety and efficacy. Some MS tightly monitor NPPs, but most do not have comprehensive information (including on availability, exact composition or pharmacovigilance issues) for these products. Importantly, there is no agreed definition at EU level on what constitutes a named patient product for allergens..