According to the requirements of Order of the Ministry of Health of Ukraine No. 426 of 26.08.2005, as amended, Annex 6, clause 3.2, sub-clause 6: "If the API and/or auxiliary substance(s) and the starting material are described in the European Pharmacopoeia, the applicant may provide a certificate of suitability issued by the European Directorate for the Quality of Medicines. In the relevant section of this module, it is considered that certificates of suitability to monographs of the European Pharmacopoeia replace the substantive data in the relevant sections specified in this module. The manufacturer of the substance must confirm in writing to the applicant that the manufacturing process has not changed since the certificate of suitability was issued by the European Directorate for the Quality of Medicines. Thus, providing a reference to the EDQM database is considered insufficient.
