Certificates of Suitability to the monographs of the European Pharmacopoeia

E386103

EDQM certificate pharmaceutical quality document regulatory certificate

Certificates of Suitability to the monographs of the European Pharmacopoeia are official documents issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) confirming that a substance’s quality complies with the relevant European Pharmacopoeia monograph, thereby simplifying regulatory approval for medicines across Europe.

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All labels observed (2)

Label	Occurrences
Certificate of Suitability to the monographs of the European Pharmacopoeia	1
Certificates of Suitability to the monographs of the European Pharmacopoeia canonical	1

Statements (48)

Predicate	Object
instanceOf	EDQM certificate ⓘ pharmaceutical quality document ⓘ regulatory certificate ⓘ
abbreviation	CEP ⓘ
alternativeTo	full active substance master file in some regulatory procedures ⓘ
appliesTo	active pharmaceutical ingredient ⓘ excipients ⓘ substances for pharmaceutical use ⓘ
basedOn	European Pharmacopoeia ⓘ
confirmsComplianceWith	European Pharmacopoeia ⓘ surface form: European Pharmacopoeia monograph quality requirements of the European Pharmacopoeia ⓘ
contains	information on impurity profile ⓘ information on manufacturing process controls ⓘ information on residual solvents ⓘ information on specific quality attributes required by the monograph ⓘ information on substance quality ⓘ
documentType	confidential assessment document for regulators ⓘ
effect	avoids duplication of quality assessment by multiple authorities ⓘ facilitates mutual recognition of quality data ⓘ streamlines dossier preparation for manufacturers ⓘ
fullName	Certificates of Suitability to the monographs of the European Pharmacopoeia ⓘ
governedBy	EDQM certification procedure ⓘ
grantedTo	manufacturers of substances for pharmaceutical use ⓘ
issuedBy	European Directorate for the Quality of Medicines & HealthCare ⓘ surface form: EDQM European Directorate for the Quality of Medicines & HealthCare ⓘ
language	issued in official EDQM languages ⓘ
purpose	demonstrate that a substance complies with a European Pharmacopoeia monograph ⓘ simplify regulatory approval for medicines in Europe ⓘ support marketing authorisation applications ⓘ
recognizedBy	European medicines regulatory agencies ⓘ national competent authorities in Europe ⓘ
regulatoryRegion	Council of Europe member states ⓘ European Economic Area ⓘ European Union ⓘ
relatedTo	Council of Europe ⓘ European Pharmacopoeia ⓘ surface form: European Pharmacopoeia Commission
requires	assessment of the manufacturer’s quality dossier by EDQM ⓘ compliance with relevant general monographs of the European Pharmacopoeia ⓘ compliance with relevant specific monographs of the European Pharmacopoeia ⓘ
subjectTo	possible suspension or withdrawal by EDQM ⓘ post-certification surveillance by EDQM ⓘ
supports	quality section of medicinal product dossiers ⓘ
usedBy	marketing authorisation holders ⓘ pharmaceutical manufacturers ⓘ regulatory authorities in Europe ⓘ
usedIn	marketing authorisation applications for medicinal products ⓘ registration dossiers for medicines ⓘ
validity	limited period subject to renewal ⓘ

Referenced by (2)

Full triples — surface form annotated when it differs from this entity's canonical label.

Certificates of Suitability (CEP) → fullName → Certificates of Suitability to the monographs of the European Pharmacopoeia ⓘ

subject surface form: Certificates of Suitability

CEP → fullForm → Certificates of Suitability to the monographs of the European Pharmacopoeia ⓘ

this entity surface form: Certificate of Suitability to the monographs of the European Pharmacopoeia