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European activities on the harmonisation of authorisation of allergens

19 April, 2017

By Prof. V Mahler

In the EU, allergen products are defined as medicinal products according to Directive 2001/83/EC. This definition includes allergen products for the in vivo diagnosis of type IV hypersensitivities. However, despite the common legal framework set out by this directive, there is a considerable heterogeneity in the approach on how EU member states are actually regulating allergen products. The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) was informed that the increased obligations related to the Pharmacovigilance legislation as well as GMP requirements, combined with limited reimbursement options in some EU Member States have led to a decreasing number of authorised allergens.

It was noted that different regulatory decisions are taken by Member States to allow allergen products on the market (marketed as named patient products vs. marketing authorisation per individual allergen or containing diverse active substances under one combined marketing authorisation). As a result of the regulatory disharmony observed in the EU and related problems thereof, the CMDh has created a drafting group that is now working on the development of proposals for harmonized regulatory approaches for allergen products within the EU.

Due to the complexity of the issues discussed in this group, it is expected that the activities will require some time to result in potential changes in the regulatory framework of allergen products. Current updates on the progress of the drafting group with respect to specific milestones will be referenced in the CMDh Meeting minutes which are publicly available at the CMDh website (http://www.hma.eu/457.html).

Furthermore, the CMDh has requested the Committee for Medicinal Products for Human Use (CHMP) to discuss the scientific requirements on allergens with lower prevalence. The CHMP agreed for a drafting group to work on a concept paper Minutes of the meeting from December 2016,

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