Ensuring compliance after removing the product information insert

Name: Ensuring compliance after removing the product information insert
Creator: Therapeutic Goods Administration
Keywords: compliance,guidances,labeling,medicines,removals

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Labelling And Packaging, Prescription Medicines, Therapeutic Goods Regulation

Published

November 1, 2023

Last updated

November 1, 2023

Description

This guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

Feedback

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2 Main files

Package Insert template

Updated on November 1, 2023

pdf

URL: https://www.tga.gov.au/sites/default/files/2023-10/package-insert-template.pdf
Permalink: https://data.openrid.co/en/datasets/r/1e9d4925-6557-428a-91cb-fd7580872e4c
MIME Type: application/pdf

Created on: November 1, 2023
Modified on: November 1, 2023

Ensuring compliance after removing the product information insert

Updated on November 1, 2023

html

URL: https://www.tga.gov.au/resources/resource/guidance/ensuring-compliance-after-removing-product-information-insert
Permalink: https://data.openrid.co/en/datasets/r/978f5a11-0008-4dd5-8c8b-6b0058405042
MIME Type: text/html

Created on: November 1, 2023
Modified on: November 1, 2023

Ensuring compliance after removing the product information insert

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

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