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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

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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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