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Information for applicants completing a pre-submission planning form

Applicable to pre-submission planning forms lodged under the prescription medicines registration process from 1 May 2014

1 May 2014

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Part 3: Declaration

How to complete this information

Read the statements and conditions. Check the corresponding box. A PPF cannot be accepted unless the applicant agrees to all the statements/conditions.

Complete the remaining fields.

Applicants are strongly advised not to lodge a PPF before the full extent of the supporting data necessary for the application to be evaluated is known to be available. In submitting a PPF, the applicant declares that it understands and agrees to comply with the TGA's requirements for an effective application and TGA's policy concerning unsolicited information. Applicants must ensure that their dossier will contain the full data set that they wish the TGA to evaluate and that the mandatory requirements (as applicable to the nature of the medicine and application type) are met.

What else do I need to do?

The TGA will advise the applicant, in writing, if any further action is required.

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