Proposals for harmonization of allergens regulation in the European Union.
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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D000485:Allergens D000818:Animals D003888:Desensitization, Immunologic D005062:European Union D005161:Facility Regulation and Control D006801:Humans D006967:Hypersensitivity D012015:Reference Standards
Harmonization Allergens regulation