How can I submit a draft monograph for inclusion in the European Pharmacopoeia?

Answer:

You can submit draft monographs to your national pharmacopoeia authority and in some instances (i.e. industry associations or other associations, manufacturers and other interested parties from non-member states of the Ph. Eur. Convention, and multinational interested parties:) to the EDQM. For your submission to qualify for consideration, an active substance or excipient must be used in a medicinal product approved in at least one European Pharmacopoeia member states.
In submitting a monograph you should:

- indicate the country/ies in which a medicinal product containing the substance is approved;
- state your willingness to provide data and samples (you shall be prepared to co-operate with the EDQM by providing data and samples).

Further information is available upon request. Where requested, data is treated in a confidential manner. This is systematically the case under the P4 procedure (products still under patent protection).

The final decision on whether the monograph will be added to the Ph. Eur. work programme will be taken by the Ph. Eur. Commission.