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CEP holders invited to comment on draft monographs published in Pharmeuropa 33.3

Certification of suitability (CEP)
CEP revision
15 July 2021
Strasbourg, France

CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.3. The table below lists the substances affected by these revisions and for which CEPs have been granted.

Users are encouraged to register for free, giving them access to Pharmeuropa on the EDQM website Pharmeuropa, Pharmeuropa Bio & Scientific Notes.

Although these draft monographs are published for public consultation only at this stage and are therefore not official standards, they will, once adopted by the European Pharmacopoeia Commission, become legally binding standards for the substances concerned. It is therefore extremely important that manufacturers and users of the substances provide feedback on these draft monographs before the commenting deadline, i.e. before 30 September 2021. Comments made after adoption of a monograph and/or the publication in the Ph. Eur. will not be considered and manufacturers and users of substances concerned may find themselves in a position where their substance does not comply with the relevant Ph. Eur. monograph, which is a legal standard in Europe.

Everyone benefits from European Pharmacopoeia monographs which reflect the quality of the substances available in Europe. The EDQM therefore strongly encourages all users of CEPs for which a draft revised monograph has been published to review the draft monographs and check whether their substance complies with the revised draft.

Feedback on a draft monograph may be submitted in different ways, depending on where the company is located:

Please consult the guide “How to comment” for more information.

Comments on draft monographs should NOT be sent directly to the Certification of Substances Department.

Amylmetacresol - 2405

Calcium acetate - 2128

Calcium ascorbate - 1182

Cholecalciferol - 72

Clodronate disodium tetrahydrate - 1777

Diclazuril for veterinary use - 1718

Estriol - 1203

Isoniazid - 146

Ondansetron hydrochloride dihydrate - 2016

Pemetrexed disodium heptahydrate - 2637

Propylthiouracil - 525

Raltegravir potassium - 2887

RRR-alpha-Tocopheryl acetate - 1257

Thiamine nitrate - 531

Tibolone - 1739


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