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Pharmaceuticals
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EU Parliament Adopts Position on Pharmaceutical Reform: Focus on Regulatory Data and Market Protection Rules
This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click here.
Overview of the Key Changes to Regulatory Data Protection
One of the primary changes—and the focus of considerable debate—is the revision of the rules regarding regulatory data protection. The new Directive's draft text devotes an entire chapter to regulatory data and market protection. You can read our initial article on the Commission’s...
July 15, 2024
3 min read
EU Pharmaceutical Law Revision: Re-Boxing Set to Become...
In April 2024, the European Parliament voted to adopt a revised...
July 11, 2024
5 min read
EU Parliament Adopts Position on Pharmaceutical Re...
On 10 April 2024, the European Parliament adopted its position...
July 9, 2024
2 min read
EU Parliament Adopts Position on Pharmaceutical Reform:...
On April 10, 2024, the European Parliament voted to adopt a revised...
June 18, 2024
4 min read
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...
May 8, 2024
6 min read
Italy: Originator to pay over €13.4 million for abusing its dominant position by misusing the patent system
In this article we look at a ground-breaking decision of the Italian Supreme Court dealing with the compensation...
May 7, 2024
19 min read
Principle of Automatic Substitution by Biosimilars
Like generic medicines, biological medicines that are very similar to another biological medicine (biosimilars)...
February 27, 2024
2 min read
HMA-EMA publish multi-annual AI workplan: further guidance on the use of AI in the medicines lifecycle
In December 2023, the joint HMA-EMA Big Data Steering Group (BDSG) published a multi-annual (2023-2028)...
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