| 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 |
| 13.1 | 04/2026 | 31/05/2026 | 01/01/2027 |
| 13.2 | 07/2026 | 31/08/2026 | 01/04/2027 |
The Certificate of Suitability for a substance for which a revised monograph will be implemented on 1 July 2026 in Issue 12.3 of the European Pharmacopoeia.
According to EU Directives 2001/83/EC and Regulation (EU) 2019/6 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” influencing the information required. In the list of revised monographs below, it is indicated which classification (“Case A” or “Case B”) is applicable. You should check which case is applicable to your substance and follow the relevant instructions below.
| Case A | Case B |
| You should update the specification of your substance according to the revised monograph If your CEP is in Hybrid or Old format No answer to this letter is expected. Updates should be included in the next request for revision submitted to EDQM (minor, major or renewal of the certificate) and identified as such at that time (such an update will be free of charge). If your CEP is in 2.0 format No answer to this letter is expected, however, exceptionally in instances where the specification appended to the CEP in 2.0 format has been impacted by the revised Ph. Eur. monograph, you may choose to request the revision of your CEP and submit an updated dossier to address this within three months of receipt of this letter. The data should include a) Module 1 in which you identify the submission as “Monograph revision Case A CEP 2.0” and discuss the changes made to the application. b) A module 3 which is updated as appropriate. The data will be reviewed within three months, and you will be informed of the outcome – a revised CEP may be issued. This procedure is free of charge, unless you submit, at the same time, a request for revision or renewal of the concerned CEP. Note: Updates to the non-mandatory sections of the monograph (e.g. “Characters”) alone are not considered as a justification for revision of the specification appended to a CEP in 2.0 format and should instead be included in the next request for revision submitted to EDQM. | 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 on-going evaluation process of the concerned application(s). |
| Name of the substance (Monograph number) | Classification | |
| Case A | Case B | |
| Atomoxetine hydrochloride (2640) | X | |
| Calcium gluconate for injection (0979) | X | |
| Chlorhexidine diacetate (0657) | X | |
| Chlorhexidine digluconate solution (0658) | X | |
| Chlorhexidine dihydrochloride (0659) | X | |
| Citalopram hydrobromide (2288) | X | |
| Clenbuterol hydrochloride (1409) | X | |
| Dihydroergocristine mesilate (1416) | X | |
| Fludrocortisone acetate (0767) | X | |
| Fluorouracile (0611) | X | |
| Hydrocortisone (0335) | X | |
| Oxygen (0417) | X | |
| Pilocarpine hydrochloride (0633) | X | |
| Pilocarpine nitrate (0104) | X | |
| Pregabalin (2777) | X | |
| Ropinirole hydrochloride (2604) | X | |
| Sodium hyaluronate (1472) | X | |
| Tryptophan (1272) | X | |
| Vitamin A concentrate (powder form), synthetic (0218) | X | |
| Water for injections (0169) | X | |
| Ziprasidone hydrochloride monohydrate (2421) | X | |
| Ziprasidone mesilate trihydrate (2649) | X | |
- A comparison of impurity profile with the updated transparency list of the monograph (3.2.S.3.2 “Impurities”, 3.2.S.4.5 “Justification of Specifications”)
- A discussion on the suitability of the revised monograph to control any impurities which are not described in it.
- An updated substance specifications/test methods description (3.2.S.4.1 “Specifications”, 3.2.S.4.2 “Analytical Procedures”)
- Certificates of analysis of 2 batches with reference to the revised monograph (3.2.S.4.4 “Batch Analysis”)
- validation and cross-validation data when an in-house method is used as an alternative to a new test method in the monograph (3.2.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 CEP
If you have any questions, please contact us using the following email address: cep@edqm.eu