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Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances
11.1 Drug Master Files and certificates of suitability
11.1.1 For drug substance sourced from a third party manufacturer
There are two mechanisms by which a sponsor can provide information about a drug substance sourced from a third-party manufacturer:
- a DMF or
- a CEP issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM).
11.1.2 For ingredients of animal or human origin
A CEP does not contain sufficient information and will not alone be accepted.
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