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2 results for: soho

SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin - interplay with the ATMP Legislation

08 May, 2024

SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin - interplay with the ATMP Legislation

By Marc Martens Lora Arifagic

Legislative process On 19 July 2022, the European Commission (‘EC’) submitted a proposal for a Regulation on standards of quality and...

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

18 Jan, 2024

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

By Marc Martens Lora Arifagic

The SoHO proposal introduces the procedure for obtaining an authorisation for SoHO preparations by the introduction of an EU-wide...