The forms on this page may need to be included in Module 1 to support your application. Refer to the relevant section of CTD Module 1 to determine if you need to include any of these forms.
Module 1.4 forms
- Local or overseas expert's declaration (pdf,124kb)
- Local or overseas expert's declaration (docx,150kb)
Module 1.6 forms
Module 1.6.1
- Drug master file, plasma master file and/or EDQM Certificates of Suitability (pdf,116kb)
- Drug master file, plasma master file and/or EDQM Certificates of Suitability (docx,150kb)
Module 1.6.2
- Applicant declaration, drug master files, plasma master files, and EDQM certificates of suitability (pdf,100kb)
- Applicant declaration, drug master files, plasma master files, and EDQM certificates of suitability (docx,147kb)
Module 1.6.3
Module 1.7 forms
Module 1.10 forms
Supporting documents
Module 1.4: 'Local' (Australian) experts
[PDF, 123.09 KB]
Module 1.4: 'Local' (Australian) experts
[DOCX, 149.17 KB]
Module 1.6.3 - Proforma Letter of Access to DMF/PMF/CEP
[DOCX, 27.67 KB]
Module 1.7 Good manufacturing practice: Details form
[PDF, 141.6 KB]
Module 1.7 Good manufacturing practice: Details form
[DOCX, 133.38 KB]
Module 1.10 Paediatric development program
[DOCX, 129.85 KB]
Module 1.10 Paediatric development program
[PDF, 212.73 KB]
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