1. The European Pharmacopoeia and Pharmeuropa
The role of the European Pharmacopoeia (Ph. Eur.)
What is Pharmeuropa?
A compendium of quality standards for medicines and ingredients for regulators and manufacturers
Harmonise quality standards of medicines for human and veterinary use in Europe
Contribute to the protection of public health
Promote free movement of medicines in Europe
It is a publication of the European Pharmacopoeia Commission (the decision making body of the European Pharmacopoeia who are responsible for elaboration and maintenance of its content).
All new and revised monographs and general texts that are intended for inclusion in the Ph. Eur. are published in Pharmeuropa for public consultation.
It is a free online publication providing:
public inquiries on draft European texts or matters of general policy,
the latest official announcements on freshly adopted monographs,
the latest news on Pharmacopoeial harmonisation,
a Readers’ tribune, and
access to three databases.
Four issues published and four comments deadlines per year.
Structure of the Ph. Eur.
General chapters
General monographs
General dosage form monographs
Monographs for vaccines, immunosera, radiopharmaceuticals, sutures, herbal and homoeopathic preparations
Specific monographs on active substances and excipients
New! Product Specific Dosage form monographs
How to access Pharmeuropa online
Mandatory texts: as per Directive 2001/82/EC
Access via the European Pharmacopoeia area of the EDQM website.
Registration necessary as access is password protected.
Specific monographs
Active substances & excipients
Compliance throughout validity period
Definition, identification, assay, tests
Not mandatory: characters, storage
General monographs
Defined by specific criteria: production, origin, risk factors, etc.
Substances for pharmaceutical use, TSE, Fermentation, Vaccines, etc.
Issues common to individual monographs to avoid repetition
Apply to all products*
Dosage form monographs
Definition, Production, Tests, Storage, Labelling
Applies to all preparations of the type defined
First specific: Sitagliptin tablets Ph. Eur. 8.8
Number of new products added to work programme
Importance of commenting
*except for Substances for pharmaceutical use: only mandatory for monographed substances otherwise compliance is dictated by the intended use of the product
It is in everyone’s interest to have Ph. Eur. monographs which reflect the quality of the substances available in Europe, therefore feedback on draft monographs from manufacturers/users of the substances is extremely important.
EDQM strongly encourage all interested manufacturers/users to review draft monographs and to check compliance of their substance with the new or revised draft monograph.
Once a draft monograph is adopted by the Ph. Eur. Commission it becomes the applicable and legally binding standard for the substance concerned.
Comments made after adoption of the monograph cannot be considered and manufacturers/users of the substances may be in a position where their substance does not comply with Ph. Eur.
Explanatory texts: General Chapters
Not mandatory except where specifically referred to in a monograph
Method of analysis, containers/closures, reagents
General texts:
Microbiology, residual solvents, impurities, reference standards, functionality related characteristics, etc.
Not mandatory except where specifically referred to in Substances for Pharmaceutical use (residual solvents, impurities) or Pharmaceutical preparations (Functionality related characteristics
Pharmacopoeial compliance requirements: example
How to comment
Carprofen monograph & Substances for Pharmaceutical use, including residual solvents & impurities
Excipients: specific monographs e.g. lactose monohydrate, magnesium stearate & Functionality related characteristics
Dosage form monograph - tablets
General monographs: Pharmaceutical preparations, Products with a risk of TSE
Carprofen tablets
Manufacturers and other interested parties from member states of the Ph. Eur. Convention – comment via the national pharmacopoeia authority with supporting analytical data where relevant.
Industry associations – comment via EDQM secretariat with supporting analytical data where relevant.