European Pharmacopoeia
The legally binding compendium for medicines and their components in the states party to the Convention on the Elaboration of a European Pharmacopoeia. Comprises general chapters, general monographs and specific monographs, and is maintained by EDQM under the Council of Europe with periodic supplements.
Any medicinal product or substance placed on the market in a Ph. Eur. signatory state. Where a monograph exists, compliance is a legal requirement rather than a recommendation.
- 01Testing against the current monograph, general monographs and applicable general chapters
- 02Version control over the Ph. Eur. edition and supplement in force
- 03Justification and validation where an alternative method is used in place of the compendial one
Ph. Eur.: frequently asked questions
Quick answers to common questions about Ph. Eur..
What is Ph. Eur.?
Ph. Eur. — European Pharmacopoeia — is a standard issued by the European Directorate for the Quality of Medicines & HealthCare (Council of Europe). The legally binding compendium for medicines and their components in the states party to the Convention on the Elaboration of a European Pharmacopoeia. Comprises general chapters, general monographs and specific monographs, and is maintained by EDQM under the Council of Europe with periodic supplements.
Who does Ph. Eur. apply to?
Any medicinal product or substance placed on the market in a Ph. Eur. signatory state. Where a monograph exists, compliance is a legal requirement rather than a recommendation.
What are the key requirements of Ph. Eur.?
EDQM Ph. Eur. requires, among other things: Testing against the current monograph, general monographs and applicable general chapters; Version control over the Ph. Eur. edition and supplement in force; Justification and validation where an alternative method is used in place of the compendial one.
When was Ph. Eur. last updated?
The current version of Ph. Eur. dates from January 2023.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When Ph. Eur. — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.