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API makers can appeal CEP suspensions, EDQM notes

This article was originally published in The Gold Sheet

Executive Summary

Manufacturers of active pharmaceutical ingredients, or active substances as they are called in Europe, can appeal decisions by the European Directorate for the Quality of Medicines and Healthcare to suspend or withdraw any of their certificates of suitability to European Pharmacopoeia monographs (CEPs), EDQM stressed in a document explaining the suspension and withdrawal policy of its Certification of Substances Division. "The possibility of appealing is clearly mentioned in the letter of notification," the agency said. EDQM also noted that it will restore CEPs after the two-year suspensions by granting a revised CEP "as soon as the conditions for lifting the suspension are met by the CEP holder." EDQM's Ad'Hoc Committee suspends or withdraws CEPs based on proposals from EDQM's Internal Decision Board, which in turn relies on inspections by EDQM or by an inspectorate of a European Economical Area member state or of a country that has a mutual recognition agreement with the European Union. EDQM has withdrawn eight CEPs, four from manufacturers in India and one each from China, Italy, Germany and Switzerland. Twenty five are currently suspended - 16 from manufacturers in China, four from India, three from South Korea and one each from Italy and Germany. EDQM lists 2,446 valid CEPs. Note: Beginning this month, EDQM is charging manufacturers for travel and accommodation expenses of its inspectors and any experts involved in inspections

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