The European Directorate for the Quality of Medicines & HealthCare (EDQM) has recently modified its policy on chemical applications for polymorphs. A request for a Certificate of suitability to the European Pharmacopoeia monographs (CEP) for a specific polymorphic form (as a grade) is now possible even if the statement “the substance shows polymorphism” is not mentioned in the “Characters” section of the corresponding individual monograph in the European Pharmacopoeia.
In such cases, the applicant should demonstrate that the substance shows polymorphism by providing data from the literature or any other appropriate evidence. The specifications for the substance should include an analytical method suitable for the characterisation of the proposed polymorphic form. If the request is accepted, a subtitle for the specific polymorph will then be added to the CEP and the method used to characterise the polymorph will be appended to it.