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. (mirza.catibusic@hpra.ie) Industry associations – comment via EDQM secretariat with supporting analytical data where relevant.