Participation in the European Pharmacopoeia's public standards setting process by the pharmaceutical industry and other stakeholders is vital for the development of authoritative and relevant European Pharmacopoeia monographs. Interested parties can participate in the following ways:
The European Pharmacopoeia encourages you to submit draft monographs. Your draft may be the starting point for an official public standard.
You can propose revisions to the general chapters and monographs in the current official edition of the European Pharmacopoeia. Submission of data for proposed alternatives is highly welcomed to allow for proper evaluation of your proposal.
According to the Guide of work of the European Pharmacopoeia:
For manufacturers and other interested parties from Member States of the Ph. Eur. Convention: requests for revision of monographs or general chapters should be submitted via the National Pharmacopoeia Authority.
For manufacturers and other interested parties from non-Member States of the Ph. Eur. Convention or multinational interested parties, for International organisations and for Industry associations or other associations: requests for revision of monographs or general chapters should be submitted to the Secretariat in Strasbourg (via the EDQM HelpDesk)
You can comment on general texts and draft monographs published in Pharmeuropa.
In all of the above cases, EDQM staff will involve you in a process of public review of the draft text in order to refine the proposals and to publish an official text in the European Pharmacopoeia.
Technical Guide for the Elaboration of Monographs of the European Pharmacopoeia (2010)
Download all Technical Guides
For information on the procedure about submitting draft monographs or revisions, please go to the Frequently Asked Questions (FAQs) & EDQM HelpDesk.