This section of Module 1 holds documents relating to drug master files (DMFs) and Certificates of Suitability of Monographs of the European Pharmacopoeia (CEPs) to establish the quality of a new chemical entity (NCE) in a medicine which is an active ingredient.

This section is relevant only to some N5 level applications that include a new active ingredient.

Note, module 1.6.4 is no longer used for certificates of suitability - complete copies of the certificates of suitability are included in module 3.2.R.

Module 1.6.1 Relevant external sources

Include this document for any N5 level application that includes a new active ingredient when the application refers to one or more:

• drug master files (DMFs)
• Certificate(s) of Suitability of Monographs of the European Pharmacopoeia (CEPs).

Preparing information about external sources

Obtain the relevant DMF/CEP details from the active substance manufacturer, including any TGA reference numbers where available.

If you are referencing a DMF or CEP, download and complete the DMF/CEP details form.

Include the completed form(s) in Module 1.6.1.

Module 1.6.2 Applicant's declaration

Include an applicant's declaration for any N5 level application that includes a new active ingredient when the application refers to one or more:

• drug master files (DMFs)
• Certificate (s) of Suitability of Monographs of the European Pharmacopoeia (CEPs).

Preparing the applicant's declaration

Establish a formal agreement with the active pharmaceutical ingredient manufacturer to ensure the manufacturer communicates any changes to the applicant and the TGA before making any significant change to the drug substance. This agreement is independent of the TGA.

Once the agreement has been established:

• download the declaration form
• complete and sign the form
• include the completed form(s) in Module 1.6.2.

Module 1.6.3 Letters of access

Include letters of access for any N5 level application that includes a new active ingredient when the application refers to one or more:

• drug master files (DMFs)
• Certificate(s) of Suitability of Monographs of the European Pharmacopoeia (CEPs).

Preparing a Letter of access

Applicant

Establish a formal agreement with the active substance manufacturer.

Manufacturer

Each manufacturer providing a DMF for the application needs to complete the Letter of access.

Each manufacturer providing a CEP for the application needs to complete the Letter of access to CEP and authorise the TGA to access relevant European Directorate for the Quality of Medicines & HealthCare (EDQM) reports.

All manufacturers provide the applicant with the completed and signed letter for inclusion in Module 1.6.3.