European Pharmacopoeia
E387634
The European Pharmacopoeia is a legally binding reference work that sets quality standards for medicines and their ingredients across member states of the Council of Europe.
All labels observed (6)
| Label | Occurrences |
|---|---|
| European Pharmacopoeia Commission | 4 |
| European Pharmacopoeia canonical | 3 |
| European Pharmacopoeia monograph | 1 |
| European Pharmacopoeia monograph requirements | 1 |
| European Pharmacopoeia monographs | 1 |
| Ph. Eur. | 1 |
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
legal standard
ⓘ
pharmacopoeia ⓘ reference work ⓘ |
| aimsTo |
ensure quality and safety of medicines
ⓘ
harmonize pharmaceutical quality standards in Europe ⓘ |
| appliesIn | member states of the Council of Europe ⓘ |
| contains |
general chapters
ⓘ
general notices ⓘ monographs ⓘ reference to reference standards ⓘ |
| defines |
acceptance criteria for tests
ⓘ
analytical methods for quality control ⓘ quality standards for medicinal products ⓘ quality standards for pharmaceutical substances ⓘ |
| hasAbbreviation |
EP
ⓘ
European Pharmacopoeia self-linksurface differs ⓘ
surface form:
Ph. Eur.
|
| hasDecisionMakingBody |
European Pharmacopoeia
self-linksurface differs
ⓘ
surface form:
European Pharmacopoeia Commission
|
| hasEditionType |
online edition
ⓘ
printed edition ⓘ |
| hasGeographicFocus | Europe ⓘ |
| hasGoverningBody |
European Pharmacopoeia
self-linksurface differs
ⓘ
surface form:
European Pharmacopoeia Commission
|
| hasLegalStatus | legally binding ⓘ |
| hasPublisher | European Directorate for the Quality of Medicines & HealthCare ⓘ |
| hasScope |
advanced therapy medicinal products
ⓘ
biological medicinal products ⓘ blood-derived products ⓘ chemical medicinal products ⓘ herbal medicinal products ⓘ human medicines ⓘ radiopharmaceuticals ⓘ vaccines ⓘ veterinary medicines ⓘ |
| isBasisFor | national pharmacopoeias in Europe ⓘ |
| isHarmonizedWith |
Japanese Pharmacopoeia
ⓘ
United States Pharmacopeia ⓘ |
| isMaintainedBy |
European Pharmacopoeia
self-linksurface differs
ⓘ
surface form:
European Pharmacopoeia Commission
|
| isOrganizedBy | Council of Europe ⓘ |
| isPublishedBy |
European Directorate for the Quality of Medicines & HealthCare
ⓘ
surface form:
EDQM
|
| isUsedBy |
national medicines agencies in Europe
ⓘ
official medicines control laboratories ⓘ pharmaceutical manufacturers ⓘ quality control laboratories ⓘ |
| regulates |
quality of active pharmaceutical ingredients
ⓘ
quality of containers and closures for medicines ⓘ quality of dosage forms ⓘ quality of excipients ⓘ quality of medicines ⓘ |
| supports |
market surveillance of medicinal products
ⓘ
regulatory assessment of medicines ⓘ |
Referenced by (11)
Full triples — surface form annotated when it differs from this entity's canonical label.
subject surface form:
Certificates of Suitability
this entity surface form:
European Pharmacopoeia monographs
this entity surface form:
European Pharmacopoeia monograph requirements
Certificates of Suitability to the monographs of the European Pharmacopoeia
→
basedOn
→
European Pharmacopoeia
ⓘ
Certificates of Suitability to the monographs of the European Pharmacopoeia
→
confirmsComplianceWith
→
European Pharmacopoeia
ⓘ
this entity surface form:
European Pharmacopoeia monograph
Certificates of Suitability to the monographs of the European Pharmacopoeia
→
relatedTo
→
European Pharmacopoeia
ⓘ
this entity surface form:
European Pharmacopoeia Commission
this entity surface form:
Ph. Eur.
this entity surface form:
European Pharmacopoeia Commission
this entity surface form:
European Pharmacopoeia Commission
this entity surface form:
European Pharmacopoeia Commission