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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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11.6 How to include a certificate of suitability in an application

Sponsors need the written permission of the drug substance manufacturer to refer to a CEP in an application.

A proforma for a Letter of Access (available in Module 1.6.3 of the CTD) from the drug substance manufacturer, addressed to the TGA and indicating clearly the product sponsor to which it applies, should be sent directly to the TGA, either with the CEP or separately.


The proforma for Letters of Access used in Europe is not acceptable.

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