CTD Module 1: Additional forms and proformas

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.

On this page: Module 1.4 forms | Module 1.6 forms | Module 1.7 forms | Module 1.10 forms

How to access a pdf or Word document

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

• Proforma letter of access to DMF/PMF/CEP (docx,28kb)

Module 1.7 forms

• Good Manufacturing Practice details (pdf,142kb)
• Good Manufacturing Practice details (docx,134kb)

Module 1.10 forms

• Paediatric development program (pdf,213kb)
• Paediatric development program (docx,130kb)