Guidelines & Codes
Update to Section 6.3 Format
CTD FORMATTED DOSSIERS
Added to web site: July 2006
Effective 1 September 2006, the required dossier format for all Intermediate-risk and High-risk New Medicine Applications will be the Common Technical Document (CTD) format.
Module 1, the country specific module, should include:
- A covering letter
- The current New Medicine Application Form
- A comprehensive table of contents
- Copies of proposed labeling
- A draft datasheet and package insert (where applicable)
- Evidence of GMP
- Copies of European Certificates of Suitability (where applicable)
- Letters of Access to required Drug Master Files (where applicable)
Incorrectly formatted dossiers will be returned to the applicant at the applicant’s expense.
Applicants should contact Medsafe prior to submission of their medicine dossier if they have any questions regarding the required format.