Proposals for harmonization of allergens regulation in the European Union

Publication date: Available online 3 November 2017
Source:Allergologia et Immunopathologia
Author(s): M. Timón
Allergen medicinal products in the European Union are regulated differently across the different Member States. Thus, whereas in some countries strict quality, safety and efficacy requirements are in place, in others, most allergens are on the market as Named Patient Products, without any regulatory oversight. This situation results on European allergic patients being exposed to totally different standards depending on where they live. Initiatives to correct this situation are needed.



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