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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:

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