Follow-up meeting of PEI and AGES-MEA on future cooperation in the regulatory treatment of allergen products.

In January 2019, representatives of PEI and AGES-MEA discussed the national legal requirements for allergens in Germany and Austria and agreed to intensify their cooperation in the future.

Subsequently, an EU-wide common and uniform picture of the future regulation of allergens was developed in an EU working group of the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) with the participation of PEI and AGES-MEA, and a corresponding guideline was published after public consultation in summer 2020 (Recommendations on common regulatory approaches for allergen products, https://www.hma.eu/90.html). Among other things, the guideline addresses an authorization requirement for a group of frequently used allergens. The contents of the guideline are also to be taken into account in the adapted EU pharmaceutical legislation.

On 12.11.2021, there was a follow-up meeting of colleagues from the PEI and AGES-MEA - virtually due to the situation - and the focus of discussion was the question of how the contents of the CMDh guideline could be incorporated into national legislation in the medium term. Furthermore, the promotion of mutual recognition procedures was emphasized and it was noted that in this way existing approvals in one country can be transferred to other countries comparatively easily.

In addition to the continued close exchange of technical information, cooperation on quality assurance measures and with regard to future EU IT projects and databases is also to be stepped up. The aim of this cooperation is to ensure optimal care for all patients with high-quality test and therapy allergens.

Vertreter des PEI und der AGES-MEA diskutierten erneut die nationalen gesetzlichen Anforderungen und Kooperation bei Allergenen.

Further inquiry note

lcm@basg.gv.at