Ph. Eur. Issue 12.1 is now available online and to download

Published 1 October 2025

The content of the European Pharmacopoeia (Ph. Eur.) Issue 12.1 is now available as part of the British Pharmacopoeia (BP) 2026 online edition. You can access this in-year update by using your existing credentials. 

Included in Issue 12.1:

  • Eight new monographs and six new general chapters. 

  • Revisions to General Notices, General Chapters and Monographs including  

    • a revision to the general chapter on N-Nitrosoames in active substances and medicinal products to include sartan-containing medicinal products in the scope of procedures A and C.Added tests: particulate contamination, Hydroxymethylfurfural, sterility labelling requirements;. 

    • improvements to the Identification methods in a number of monographs for Herbal Drugs. 

The amended contents of the supplement can be viewed here: 

View contents now

Customers who purchased BP 2026 download can obtain the latest version by completing the request form using the same code from their original purchase. 

Users should note that all Ph. Eur. Issue 12.1 texts are marked with orange banners as the entirety of this Issue has been incorporated into the BP 2026. 

The texts of 12.1 will become legally effective on the 1 January 2026 

BP has published new guidance on Replication Competent Virus (RCV) testing which is available to BP Users as part of the 12.1 in-year update.

Ensuring that viral vectors are not replication-competent is an important safety step when they are used in, or to make, Advanced Therapy Medicinal Products (ATMPs). Because different types of viral vectors have different risks, the safety checks and testing needed can vary widely. The new guidance offers non-mandatory advice on how to test for replication competency in commonly used viral vectors, such as Adeno-Associated Virus (AAV) and Lentivirus (LV) and shares best practices from across the industry.

If you require any assistance, please email esupport@williamslea.com