Ph. Eur. General Notices Chapter - New Structure and Content

Recommendation

6/7 June 2023

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The European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of Ph. Eur. chapter 1. General Notices to provide greater clarity for users.

New structure and content

The revised Ph. Eur. chapter 1 General Notices features new additions such as

• a section on monographs for medicinal products containing chemically defined APIs. This new section also provides information on related substances and impurities.
• a sub-section on “Demonstration of suitability of monographs”.
• a single section concerning monographs on herbal drugs, containing all paragraphs that were previously dispersed throughout the text.
• an explanation of the rounding rule, information on chiral substances and an example of equivalents (in the tests and assay sections).

• a clarification of the scope of first and second identification series and of alternative identifications.

In addition, the wording and terminology have been further harmonized. For example,

• “medicinal product” is selected instead of “finished product” and “pharmaceutical preparation”.
• “shelf life” and “re-test period” will be used instead of “period of use” and “period of validity”.

The revised Ph. Eur. chapter 1 General Notices will be published in Ph. Eur. Supplement 10.7, available in October 2021 (implementation date: 1 April 2022).

More information can be found in the EDQM Newsroom: Adoption of the revised General Notices chapter.