Page History

Answer:

You can should normally submit draft monographs to your national pharmacopoeia authority and in . In some instances (ie.eg. industry associations or other associations, manufacturers and other interested parties from non-member states of states that are not signatories to the Ph. Eur. Convention, and multinational interested parties:) it is possible to submit proposals to the EDQM directly. 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 country that is a signatory to the Ph. Eur. Convention (Ph. Eur. member state).

When 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

...

• should 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 Data is always treated confidentially for P4 procedures (products still under patent protection).

...