The authorisation status of allergen products
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10/05/2019
The authorisation status of allergen products, both for diagnosis and therapy, in the European Union is heterogeneous.
In order to facilitate harmonisation throughout the EU, the CMDh Drafting Group on harmonisation of the regulatory approaches for allergens created a guideline with intention to provide principles and guidance for the regulation of medicinal allergen products.
Currently, public consultation of the guideline proposed is open until 03/08/2019. Interested Parties (e.g. companies, health care professionals and patients) are invited to provide comments.
Link to public consultation of the guideline: https://www.hma.eu/90.html#c6481
Page last modified:
10/05/2019