The SoHO proposal introduces the procedure for obtaining an authorisation for SoHO preparations by the introduction of an EU-wide procedure. SoHO preparations are defined as a particular type of SoHO that:
(a) has been subjected to one or more SoHO activities, including processing, in accordance with defined quality and safety parameters;
(b) meets a pre-defined specification; and
(c) is intended for application to a recipient for a specific clinical...
January 18, 2024
7 min read
