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SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – Preparation Authorisation under the SoHO Proposal
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