Pharmaceuticals

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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
Principle of Automatic Substitution by Biosimilars
Like generic medicines, biological medicines that are very similar...
February 27, 2024
2 min read
HMA-EMA publish multi-annual AI workplan: further guidance...
In December 2023, the joint HMA-EMA Big Data Steering Group (BDSG)...
January 16, 2024
4 min read
The Legal 500: Pharmaceutical Advertising Country Comparative Guide 2023
The latest edition of the Legal 500: Pharmaceutical Advertising Comparative Guide is now online....
December 18, 2023
1 min read
Polish government, business associations respond to EU pharmaceutical law reform
Following the EC's announcement of the European Pharmaceutical Strategy[1], the Polish government and...
November 24, 2023
8 min read
Reforming the European pharmaceutical legislation: Shortages of medicinal products
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
August 7, 2023
5 min read
What does the European Commission’s proposed reform of EU pharmaceutical legislation mean for Paediatric medicines?
This article is part of a series that covers the proposed reforms to EU pharmaceutical...
July 26, 2023
4 min read
Reform of the EU pharmaceutical legislation: proposals to fight against antimicrobial resistance
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
July 10, 2023
4 min read