EDQM FAQs
CEP 2.0
- SPOR OMS Organisation & Location IDs
- Where can I get or modify a SPOR OMS Organisation & Location ID?
- Do intermediate manufacturers need to apply for a SPOR OMS Organisation & Location ID?
- Will my CEP 2.0 be revised if I submit a change in the address of a manufacturing site?
- Will my hybrid CEP be revised if I submit a change in the address of a manufacturing site?
- Revisions/renewals
- Where can I find the due date for the renewal of my Certificate of Suitability (CEP)?
- If the changes I want to introduce do not affect the content of my CEP, do I need to submit a revision of my dossier?
- Do I need to submit an updated holder's commitment when submitting a request for revision?
- For an upcoming renewal, do the CEP 2.0 requirements have to have been implemented before submitting a renewal application or will this be requested during the assessment process?
- Will CEPs 2.0 be renewed?
- Will the CEP be revised if a monograph revision only affects the specifications for impurities?
- Public database
- Old CEP, hybrid CEP and CEP 2.0
- CEP 2.0 and content of the application
- What are the requirements for the quality of water used in the last steps of the synthesis and reported on the CEP 2.0?
- How can I get confirmation that a specific grade (e.g. micronised, milled, etc.) described in my CEP dossier is approved by the EDQM?
- How can we provide two distinct sections (3.2.S.4.2) in our eCTD* sequences?
- CEP 2.0 requires maximum daily dose (MDD), route of administration and treatment duration to be provided in S.1.3. However, these characteristics do not apply to active ingredients. What should I do?
- Is it possible to apply for a re-test period when only 3 months of accelerated/long-term stability studies are available at the time of the original submission?
- What will be the procedure for deleting non-approved information from the dossier?
- Letter of access – Declaration of access box
- Sister file
General information on Substances for pharmaceutical use
- General and scope
- What does ‘CEP’ mean?
- How to use a CEP?
- Is CEP mandatory for marketing a substance in EU countries?
- How should the certificate coding be interpreted?
- How do I know if I have the latest valid version of a CEP?
- Can I get a copy of a certificate from the EDQM?
- Does the Certification procedure apply to herbal drugs and herbal drug preparations?
- How long does it take to obtain a certificate of suitability?
- Which countries accept certificates of suitability?
- Is a certificate of suitability equivalent to a GMP certificate?
- Is it possible to apply for a CEP for biological substances?
- How can I withdraw my CEP?
- What does “P0X” or “PXX” mean as an extension to the CEP number on EDQM CEP communication letters (Re: CEP 202X-XXX-P0X or PXX / Substance name)?
- Quality Overall Summary (QOS)
- Application dossier
- Are alternative methods accepted?
- Are analytical procedures appended to a CEP considered equivalent to a European Pharmacopoeia monograph method?
- Can some tests be omitted?
- Should all tests referred to in a CEP be performed for routine analysis/batch release?
- Is a certificate of suitability equivalent to a certificate of analysis?
- How should I deal with different grades of the same substance?
- How should I deal with recovery of materials in a dossier?
- Does skip testing need to be declared in CEP application dossier?
- What should we do if we use peptones in the manufacture an active substance?
- Is it possible to apply for a Chemical CEP with reference to a specific polymorphic form when no statement on polymorphism is included in the corresponding individual Ph. Eur. monograph?
- In our CEP application, is it possible to claim that the quality of our substance complies with a specific degree of hydration when degree of hydration is not defined in the corresponding individual Ph. Eur. monograph?
- In the revised Ph. Eur. monograph, a degree of hydration has been either removed from / clarified in the title of the substance. Will EDQM issue a new certificate of suitability to reflect this?
- Sterile substances
- TSE
- E-submission
- Fees
Revisions/ Renewals
- When should the applicant request a renewal?
- When is a CEP revised?
- (NEW 15/11/2024) How do I submit a grouped notification or grouped transfer of holdership?