The implementation date for the 8th Edition is 1 January 2014 and this edition will, over the next 3 years, be augmented with 8 supplements containing the texts adopted at the sessions of the European Pharmacopoeia Commission. As ever, it is published in the 2 official languages of the Council of Europe, i.e. English and French, both as a printed version and electronically (online and on a USB key). It is noteworthy that certain member states undertake national or regional translations, which they incorporate into their own national pharmacopoeias.
Member States of the 8th Edition the European Pharmacopoeia Application
The European Pharmacopoeia is prepared under the auspices of the Council of Europe in accordance with the terms of the Convention on the Elaboration of a European Pharmacopoeia (European Treaty Series No. 50) (‘the Convention’) as amended by the protocol to the Convention (European Treaty Series No. 134), signed by the governments of 37 member states (Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, ‘the former Yugoslav Republic of Macedonia’, Turkey, Ukraine and United Kingdom) and by the European Union.
The preparation of the European Pharmacopoeia is the responsibility of the European Pharmacopoeia Commission (‘the Commission’), appointed in accordance with article 5 of the Convention. It is composed of delegations appointed by the contracting parties. Each delegation consists of not more than 3 members chosen for their competence in matters within the functions of the Commission.
Observers of the European Pharmacopoeia 8th Edition
Observers from non-member states and international organisations are admitted to sessions of the Commission in accordance with the Rules of Procedure. Observers are at present admitted from: Albania, Algeria, Argentina, Armenia, Australia, Brazil, Canada, China, Georgia, Israel, Madagascar, Malaysia, Moldova, Morocco, Republic of Belarus, Republic of Guinea, Republic of Kazakhstan, Republic of Singapore, Russian Federation, Senegal, Syria, Tunisia, United States of America and the World Health Organization.
The Convention is open for signature by European countries and observer status can serve to familiarise European countries intending to become signatories with the working methods of the Commission. The Commission recognises that relations with countries outside Europe are essential in view of the globalisation of the supply chain for pharmaceuticals. Observer status for non-European countries helps to foster these relations by facilitating regulatory partnerships and the exchange of information and working documents.
The Functions of the Commission
The functions of the Commission established by article 6 of the Convention as amended by the protocol are:
“Subject to the provision of Article 4 of the present Convention, the functions of the Commission shall be:
(a) to determine the general principles applicable to the elaboration of the European Pharmacopoeia;
(b) to decide upon methods of analysis for that purpose;
(c) to arrange for the preparation of and to adopt monographs to be included in the European Pharmacopoeia and;
(d) to recommend the fixing of the time limits within which its decisions of a technical character relating to the European Pharmacopoeia shall be implemented within the territories of the contracting parties.”
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe supports the Commission in the elaboration and revision of texts of the European Pharmacopoeia by providing the scientific secretariat. In addition, it is responsible for the establishment, production, monitoring and distribution of reference standards needed when applying the monographs. The EDQM is also active in a number of other areas related to the protection of public health, for example in certifying the quality of active pharmaceutical ingredients from specific sources and in biological standardisation.
In accordance with the terms of the Convention, the contracting parties undertake to take the necessary measures to ensure that the monographs of the European Pharmacopoeia shall become the official standards applicable within their respective territories.
The Purpose of the European Pharmacopoeia
The purpose of the European Pharmacopoeia is to promote public health by the provision of recognised common standards for the quality of medicines and their components. Such standards are to be appropriate as a basis for the safe use of medicines by patients. In addition, their existence facilitates the free movement of medicinal products in Europe and beyond.
European Pharmacopoeia monographs and other texts are designed to be appropriate to the needs of:
– regulatory authorities;
– those engaged in the quality control of medicinal products and their components;
– manufacturers of medicinal products and their components.
The European Pharmacopoeia is widely used internationally. As globalisation and expansion in international trade present a growing need to develop global quality standards for medicines, the Commission works closely with all users of the Pharmacopoeia worldwide.
General Rules of the European Pharmacopoeia
General rules for interpretation of the texts of the European Pharmacopoeia are given in the General Notices. The following information should also be noted.
The general principles applied in the elaboration of monographs of the European Pharmacopoeia are laid down in procedures and in technical guides available on the EDQM website. The principles applied are revised from time to time without complete retrospective application so that monographs already published may not always follow the latest recommendations, but wherever an issue with an impact on public health is identified, monographs are revised.
It is recognised that general chapters are also used elsewhere than in the monographs of the European Pharmacopoeia; in these circumstances users are recommended to consult the relevant technical guide, which gives extensive information on the application of many of the methods.
The Work Programme
The work programme (elaboration of new monographs or general chapters or revision of existing texts) is decided by the Commission at one of the three annual sessions. In general, whenever 2 member states express a wish to elaborate a monograph, the Commission adds the item to the work programme. Changes to the work programme are published on the EDQM website and in Pharmeuropa Online. Information is also provided to industry associations registered with the secretariat and to manufacturers’ liaison contacts. Interested parties are invited to contact the secretariat for any items where they wish to be involved in the work.
The Certification Procedure
A procedure for the certification of suitability of monographs of the European Pharmacopoeia with respect to quality control of a product from a given source has been established (see Public Health Committee (Partial Agreement) Resolution AP-CSP (07) 1 or any subsequent revision, available from the EDQM and on its website) as an aid to the use of monographs in applications for marketing authorisation. The certification procedure also applies to herbal drugs, herbal drug preparations and transmissible spongiform encephalopathy (TSE) risk. Certificates of suitability are issued by the EDQM only for substances produced under a suitable quality system. Certificates are granted with respect to published monographs. Details of the operation of this scheme are available from the secretariat and on the EDQM website. A daily updated list of certificates granted is available online on the EDQM website, including voided or suspended certificates.
The official version of the European Pharmacopoeia is available in English and in French, in the form of a book with 3 supplements per year, and in electronic format (online, including a tablet version, and on USB stick).
Pharmeuropa, the European Pharmacopoeia forum, is published 4 times per year as an aid for the elaboration of monographs and as a vehicle for information on pharmacopoeial and related matters. Pharmeuropa Bio & Scientific Notes, a publication indexed by bibliographic services, includes scientific papers related to the establishment of biological reference preparations and validation of biological methods within the Biological Standardisation Programme of the EDQM, and to various aspects of pharmaceutical analysis and other subjects relevant to the European Pharmacopoeia.Since 2012, both publications are only available online, free of charge, and individual drafts and scientific papers are published on an ongoing basis
Information on activities and many other aspects of the European Pharmacopoeia is to be found on the EDQM website.
Implement of the European Pharmacopoeia
The date on which monographs are to be implemented is fixed by a resolution of the European Committee on Pharmaceuticals and Pharmaceutical Care (Partial Agreement) of the Council of Europe, following a recommendation by the Commission. This date is usually 1 year after adoption and about 6 months after publication. Where a monograph is to be implemented at a date earlier than the next publication date of the European Pharmacopoeia or a supplement, a resolution of the European Committee on Pharmaceuticals and Pharmaceutical Care gives the full text to be implemented. The text is also published in Pharmeuropa Online for information and posted on the EDQM website as part of the resolution.
Revision of the European Pharmacopoeia
Monographs and other texts of the European Pharmacopoeia are revised as necessary following a decision of the Commission. Revision proposals are published in Pharmeuropa Online. Proposals to revise monographs may be submitted by a delegation, by the Chair of the Commission or by the chair of a group of experts. Requests for revision from other parties should be submitted via the national pharmacopoeia authority of a member state or, where this is not possible, to the EDQM via the HelpDesk. Proposals to revise monographs must be accompanied by sufficient data to justify the need for revision.