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Posts with tag Pharmaceutical
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SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – SoHO establishment authorisation
Legislative process
On July 19, 2022, the European Commission introduced a proposal for a regulation focusing on the quality and safety standards of substances of human origin intended for human use (SoHO Proposal). This initiative draws insights from experiences, notably the recent Covid-19 pandemic, and aims to mitigate the risk of disease transmission through blood, tissues, and cells while ensuring an adequate supply.
The Council established its negotiating mandate on October 25, 2023. Negotiations...
January 10, 2024
6 min read
Polish government, business associations respond to...
Following the EC's announcement of the European Pharmaceutical...
November 24, 2023
8 min read
Public Procurement for Biological Medicines in Belgium:...
Introduction
The Royal Decree of September 13, 2023 (‘RD’),...
September 27, 2023
7 min read
Reforming the European pharmaceutical legislation:...
This article is part of a series that covers the proposed...
August 7, 2023
5 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
Proposed reform of the EU pharmaceutical legislation: New regime for orphan medicinal products under the proposed regulation
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
June 27, 2023
4 min read
Strengthened Environmental Risk Assessment requirements under the proposed new directive on medicinal products for human use
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
June 23, 2023
3 min read
Guide to EU and UK Pharmaceutical Regulatory Law 2023
Eighth Edition, Edited by Sally Shorthose
The Guide to EU and UK Pharmaceutical Regulatory...
January 31, 2023
3 min read