Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances

This guidance is intended for manufacturers of drug substances for prescription medicines, and sponsors of prescription medicines sourcing drug substances from a third party manufacturer.

Contents

• Drug Master Files and Certificates of Suitability
• What substances require a Drug Master File
• Sponsor's obligations regarding Drug Master Files
• Additional information in Drug Master Files for some drug substances
• When to include a Certificate of Suitability in an application
• How to include a Certificate of Suitability in an application
• Sponsor's obligations regarding Certificates of Suitability
• Additional information regarding Certificates of Suitability for some drug substances
• Other information that may be requested by the TGA in relation to Certificates of Suitability

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