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Posts with tag Europe
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SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – interplay with the Advanced Therapy Medicinal Products (‘ATMP’) Legislation
Legislative process
On 19 July 2022, the European Commission (‘EC’) submitted a proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application (‘SoHO Proposal’) to enhance safety standards for human substances, repealing the current Blood, Tissues and Cells (‘BTC’) legislative framework. The Current BTC legislative framework consists of the Blood Directive (Council Directive 2002/98/EC of 27 January 2003 setting standards of quality...
May 8, 2024
6 min read
Italy: Originator to pay over €13.4 million for abusing...
In this article we look at a ground-breaking decision of the...
May 7, 2024
19 min read
Developments in the Netherlands on preventing unwanted...
On 8 April 2024, the Dutch Minister of Medical Care (the
April 30, 2024
6 min read
SOHO ALERT: A Comprehensive Guide to the Proposed Regulation...
Legislative process
On July 19, 2022, the European Commission...
January 10, 2024
6 min read
Code of practice introduced for holding cultivated meat tastings
Particularly in the Netherlands, developments in the field of cultivated meat have succeeded each other...
July 12, 2023
6 min read
A Guide to the UPC and the UP
The opening of the Unified Patent Court (UPC) on 1 June 2023 may be the most significant development...
June 9, 2023
2 min read
Revamping the European pharmaceutical industry: A closer look at the EU’s proposed legislative framework
On 26 April 2023, the European Commission published the long-anticipated proposal for the revision of...
April 28, 2023
3 min read
Single-arm clinical trials: EMA launches consultation
In contrast to randomised controlled trials (RCTs), single-arm clinical trials (SATs) are relatively...
April 26, 2023
2 min read