Reformatting Product Information: Frequently asked questions

Name: Reformatting Product Information: Frequently asked questions
Creator: Therapeutic Goods Administration
Keywords: access,checklists,faq,fees,forms,frequently-asked-questions,guidances,sponsors,templates,updates,waiver

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Prescription Medicines, Prescription Medicines Collection

Published

February 27, 2024

Last updated

February 27, 2024

Description

Update about the transitionary arrangements for reformatting product information, including accessing a fee waiver

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

Feedback

Suggest an improvement to this page

6 Main files

Product Information template

Updated on February 27, 2024

dotx

URL: https://www.tga.gov.au/sites/default/files/pi-template-new-format.dotx
Permalink: https://data.openrid.co/en/datasets/r/08da07ab-01fb-49d6-be2e-945fd5a39a20
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.template

Created on: February 27, 2024
Modified on: February 27, 2024

New Product Information (PI) format – checklist for sponsors

Updated on February 27, 2024

docx

URL: https://www.tga.gov.au/sites/default/files/new-product-information-format-checklist-for-sponsors.docx
Permalink: https://data.openrid.co/en/datasets/r/ab1f29b7-7c17-4d8e-a2d8-249fda304c46
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: February 27, 2024
Modified on: February 27, 2024

Product Information template with black triangle

Updated on February 27, 2024

dotx

URL: https://www.tga.gov.au/sites/default/files/pi-template-new-format-with-black-triangle.dotx
Permalink: https://data.openrid.co/en/datasets/r/054bf24a-55c3-4d91-9214-91aa4374825c
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.template

Created on: February 27, 2024
Modified on: February 27, 2024

PI form - annotated to show new content

Updated on February 27, 2024

pdf

URL: https://www.tga.gov.au/sites/default/files/product-information-form-annotated-to-show.pdf
Permalink: https://data.openrid.co/en/datasets/r/9bf5b39f-18ff-4194-8185-af71ad46562a
MIME Type: application/pdf

Created on: February 27, 2024
Modified on: February 27, 2024

Reformatting Product Information - Frequently asked questions

Updated on February 27, 2024

pdf

URL: https://www.tga.gov.au/sites/default/files/reformatting-product-information-frequently-asked-questions.pdf
Permalink: https://data.openrid.co/en/datasets/r/a1018722-8ccd-41fd-9363-5ce1e282c0c3
MIME Type: application/pdf

Created on: February 27, 2024
Modified on: February 27, 2024

Reformatting Product Information: Frequently asked questions

Updated on February 27, 2024

html

URL: https://www.tga.gov.au/resources/resource/guidance/reformatting-product-information-frequently-asked-questions
Permalink: https://data.openrid.co/en/datasets/r/0c09d9ee-5f28-488a-8dec-79f71ad36b0b
MIME Type: text/html

Created on: February 27, 2024
Modified on: February 27, 2024

Reformatting Product Information: Frequently asked questions

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

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