The Relationship between the BP and the Ph. Eur.

The British Pharmacopoeia (BP) has published a new “Key Insights” article entitled "Understanding the relationship between the BP and the Ph. Eur.".

The article explains the relationship between the British Pharmacopoeia (BP) and the European Pharmacopoeia (Ph. Eur.), and how the UK contributes to the development of European pharmacopoeial standards. The Key Insights article points out that the Ph. Eur. is not an EU publication. It is published by the European Directorate for the Quality of Medicines (EDQM), part of the Council of Europe. The Ph. Eur. is legally binding in 39 member states, including the United Kingdom.

How BP and Ph. Eur. content work together

According to the article, the BP includes all Ph. Eur. texts as well as national British Pharmacopoeia monographs. This brings the standards together in one publication for BP users. The article notes that European texts are identified by a “chaplet of stars” and that national BP monographs can refer to relevant Ph. Eur. requirements.

As an example, the article describes the BP 2027 national monograph for Melatonin Oral Solution. It refers to national BP general notices and requirements for oral liquids, as well as to Ph. Eur. monographs for melatonin and oral liquids. Both BP and Ph. Eur. standards have legal status in the UK.

The UK’s Contribution to European Standards

The article further explains that the BP acts as the UK’s National Pharmacopoeia Authority. In this role, it coordinates UK comments on draft texts during PharmEuropa consultations, nominates UK experts to European working groups and supports the UK Delegation at the European Pharmacopoeia Commission.

Finally, the Key Insights article highlights the BP’s international collaboration beyond Europe, including work with the World Health Organization, the United States Pharmacopeia and the Indian Pharmacopoeia.

For more information please see the British Pharmacopoeia Key Insights.