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Listed medicine presentation and labels Australian regulatory guidanceVersion 1.1, September 2020Therapeutic Goods AdministrationCopyright Commonwealth of Australia 2020 This work is copyright. You
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To fill out a listed medicine presentation, follow these steps:
02
Start by gathering all the necessary information about the medicine you are presenting.
03
Begin with the medicine's name and dosage form.
04
Specify the active ingredients along with their quantity.
05
Include information about any other non-active ingredients or excipients.
06
Provide details about the medicine's indications and contraindications.
07
Include dosage instructions and recommended usage.
08
Mention any potential side effects or adverse reactions.
09
List any special warnings or precautions that need to be taken while using the medicine.
10
Provide information about storage conditions.
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Include the date of the presentation and any additional relevant information.
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Finally, proofread and review the presentation to ensure accuracy and completeness.

Who needs listed medicine presentation and?

01
Listed medicine presentations are needed by:
02
- Pharmaceutical companies for regulatory approval and marketing purposes.
03
- Healthcare professionals to understand the medicine's specifications and usage instructions.
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- Regulatory authorities to evaluate and approve the medicine for public use.
05
- Patients and consumers to gain knowledge about the medicine they are using or considering to use.
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Listed medicine presentation refers to the formal submission of specific details about medicines that are listed for public access and regulatory purposes.
Manufacturers, importers, and distributors of listed medicines are required to file a listed medicine presentation.
To fill out a listed medicine presentation, one must complete the designated form, providing all required information regarding the medicine, including its ingredients, usage, and labeling.
The purpose of listed medicine presentation is to ensure that medicines meet regulatory standards, provide necessary information for safe use, and facilitate public access to information about products.
The information that must be reported includes the medicine's name, active ingredients, dosage form, directions for use, and any relevant safety information.
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