Swissmedic: Updated Information on Non-Standardized Medicinal Products
Swissmedic has issued an update regarding non-standardized medicinal products, revising an information sheet and the list of products impacted by a specific manufacturing regulation. This product category addresses patient-specific preparations.
In the update, the preparations "platelet-rich plasma" and "platelet-rich fibrinogen" have been replaced with the broader category "platelet products for autologous or allogeneic use." Additionally, the update includes new information about the establishment licenses required for the manufacturing and distribution of these non-standardized medicinal products. Other revisions pertain to legal provisions related to preparations intended solely for cosmetic purposes.
These updates impact an annex listing medicinal products and product groups subject to mandatory authorization due to their manufacturing processes.
Source:
Swissmedic: ATMPs-Information
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