Get Guidance On Paediatric Submissions

This guide provides a comprehensive overview for users on how to effectively complete the Guidance On Paediatric Submissions online. It is designed to assist individuals in navigating the required components and fields of the submission process with clarity and support.

Follow the steps to successfully complete your submission.

1. Press the ‘Get Form’ button to access the form and open it in your editor.
2. Begin by carefully reading through the introduction section to understand the context and purpose of the submission process. Ensure you have all necessary documents ready, as outlined later in the guide.
3. In the cover letter section, clearly specify whether your application is for a paediatric investigation plan (PIP) or a product specific waiver. Include the assigned product number and the checksum number generated when saving your electronic application.
4. If applicable, include a letter of authorisation. This document can authorize up to two individuals to communicate on your behalf. Ensure it is printed, signed, and then scanned into a PDF format.
5. Complete the electronic form for the paediatric-investigation-plan application. It must be electronically signed. Refer to the guideline on e-signatures for detailed instructions.
6. For the key elements form, outline significant elements in a bullet-point format without including background information. This should serve as a concise summary of your proposal.
7. Compile all additional documents, such as literature references and supporting information, into a single zip file following the specified naming conventions.
8. Double-check all entries for accuracy and completeness. Once you have finalized the application, you can save your changes, download a copy for your records, or print the completed form.
9. Upon completion, submit the application according to the guidelines specified in the document. Ensure that you keep a record of your submission for future reference.

Start completing your Guidance On Paediatric Submissions online today.