| Issue | Publication date | Correction date | Implementation date |
| 12.1 | 07/2025 | 31/08/2025 | 01/01/2026 |
| 12.2 | 10/2025 | 30/11/2025 | 01/04/2026 |
| 12.3 | 01/2026 | 28/02/2026 | 01/07/2026 |
The Certificate of Suitability for a substance for which a revised monograph will be implemented on 1st January 2026 in Supplement 12.1 of the European Pharmacopoeia.
According to EU Directives 2001/83/EC and 2001/82/EC as amended, it is your responsibility to update your application to comply with the revised version of the Ph. Eur. Monograph and to update the specification accordingly. The need to submit information to EDQM depends on the changes made to the monograph. Updates to the monographs are classified by EDQM into “Case A” and “Case B,” and this influences the information required. In the list of revised monographs below, it is indicated which classification (“Case A” or “Case B”) is applicable.
| Case A | Case B |
| Holder should update the specification of your substance according to the revised monograph, but no answer to this letter is expected. These updated specifications should be included in the next request for revision that you submit to EDQM (minor, major, or renewal of the certificate) and identified as such at that time (such an update will be free of charge). | This case concerns amendments to the monograph which require the submission of data to EDQM. You have to provide an updated dossier demonstrating that your substance complies with the requirements of the revised monograph, within three months of receipt of this letter. Please note that an answer is required. Failure to answer may challenge the validity of the concerned granted certificate(s) or delay the ongoing evaluation process of the concerned application(s). |
| Name of the substance (Monograph number) | Classification | |
| Case A | Case B | |
| Starches, hydroxyethyl (1785) | X | |
| Amitriptyline hydrochloride (0464) | X | |
| Amlodipine besilate (1491) | X | |
| Bromperidol (1397) | X | |
| Clomipramine hydrochloride (0889) | X | |
| Clonazepam (0890) | X | |
| Clopidogrel besilate (2790) | X | |
| Clopidogrel hydrogen sulfate (2531) | X | |
| Codergocrine mesilate (2060) | X | |
| Dicloxacillin sodium monohydrate (0663) | X | |
| Dosulepin hydrochloride (1314) | X | |
| Escitalopram oxalate (2733) | X | |
| Esomeprazole magnesium dihydrate (2787) | X | |
| Esomeprazole magnesium trihydrate (2372) | X | |
| Esomeprazole sodium (2923) | X | |
| Fluconazole (2287) | X | |
| Fluticasone propionate (1750) | X | |
| Homatropine hydrobromide (0500) | X | |
| Hypromellose (0348) | X | |
| Indometacin (0092) | X | |
| Lacosamide (2992) | X | |
| Lamivudine (2217) | X | |
| Levetiracetam (2535) | X | |
| Macrogols (1444) | X | |
| Nicotine ditartrate dihydrate (2599) | X | |
| Nitrendipine (1246) | X | |
| Oxytetracycline hydrochloride (0198) | X | |
| Pentobarbital sodique (0419) | X | |
| Pivmecillinam hydrochloride (1359) | X | |
| Remifentanil hydrochloride (2644) | X | |
| Rivaroxaban (2932) | X | |
| Ropivacaine hydrochloride monohydrate (2335) | X | |
| Rotigotine (3014) | X | |
| Salicylic acid (0366) | X | |
| Sitagliptin phosphate monohydrate (2778) | X | |
| Sodium hydrogen carbonate (0195) | X | |
| Sodium polystyrene sulfonate (1909) | X | |
| Tapentadol hydrochloride (3035) | X | |
| Ursodeoxycholic acid (1275) | X | |
| Alprazolam (1065) | X | |
A short discussion on the changes made to the application and an answer to the following two questions. It is important that you reproduce these questions and provide answers to them, since this is critical information to speed-up the treatment of your application.
Question 1: Do you control all related substances using only the method described in the revised monograph? YES / NO
Question 2: Does your substance contain any impurities which are not described in the revised monograph (and which are found above the reporting threshold of the General Monograph 2034)? YES / NO
Module 3 (As needed):- Comparison of impurity profile with the updated transparency list of the monograph (2.S.3.2 Impurities & 3.2.S.4.5 Justification of Specifications)
- Discussion on the suitability of the revised monograph to control any impurities which are not described in it.
- Updated substance specifications/test methods description (2.S.4.1 Specifications, 3.2.S.4.2 Analytical Procedures)
- Certificates of analysis of 2 batches with reference to the revised monograph (2.S.4.4 Batch Analyses)
- Validation and cross-validation data when an in-house method is used as an alternative to a new test method in the monograph (2.S.4.3 Validation of Analytical Procedures)
If the requested information has already been presented in the approved dossier, a simple letter stating this is deemed sufficient.
No application form is required unless you submit at the same time another revision. More information on ways of submission and format of the dossier can be found on the EDQM website.
Upon receipt, the data will be reviewed within 3 months, and you will be informed of the outcome of the evaluation. The assessment may also result in a revised CEP being granted.
This procedure is free of charge, unless you submit, at the same time, a request for revision or renewal of the concerned Certificate of Suitability.
If you have any questions, please contact us using the following email address: cep@edqm.eu