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Updated pre-submission planning form
The Pre-submission Planning Form (PPF) has been amended to:
- remove the requirement for applicants to have Good Manufacturing Practice (GMP) clearance for overseas manufacturing sites valid for at least six months from date of application lodgement. For applications lodged from 1st May 2014, applicants are required to have active GMP clearance or an active application with the TGA to extend or issue GMP clearance for the proposed overseas manufacturing sites.
- The TGA requirement for applicants to have appropriate GMP clearances before a medicine can be approved is not affected by this change.
- provide clarity on the types of applications that require submission of a risk management plan (RMP) and on RMP formatting requirements, and include a link to further information available currently on the TGA website pharmacovigilance pages.
Correction of typographical and other minor errors in the PPF have also been made.
Amendments in line with the above changes have also been made to the:
- Information for applicants completing a pre-submission planning form
- Mandatory requirements for an effective application
- CTD Module 1
Applicants must ensure they use the PPF form dated April 2014 for all future applications.