
You are here
CTD Module 1: Additional forms and proformas
Related information
29 November 2018
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.
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)