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Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances
9 August 2013
11.5 When to include a certificate of suitability in an application
A CEP may be submitted instead of a DMF:
- for a Category 1 application to register a new prescription medicine.
- for a request to make a variation to include an additional site of drug substance manufacture.
- when a drug substance manufacturer ceases the operation of a DMF and refers to a CEP instead.
For ingredients of animal or human origin:
A CEP does not contain sufficient information and will not alone be accepted.
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