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Prescribing Information for Australia - Question 1

Therapeutic goods are health-related products used for humans. It includes medicines like complementary, over the counter or prescriptions, medical devices like bandages and others like blood products and disinfectants (Grove, 2019).

Section 3 of the Therapeutic Goods Administration Act, 1989 defines 'therapeutic goods' as

  • One that could be taken as an ingredient for manufacturing therapeutic goods
  • One that could be used to replace or modify any part of the anatomy.

Majorly these are products used for humans for diagnosing and curing any disease, ailment, injury; modifying the physiological process; testing the patients for any disease or testing pregnancy (AG, 2020).

Prescribing Information for Australia - Question 2

Section 23 of the Therapeutic Goods Act, 1989 entails about the registration of therapeutic goods. Under this, an application has to be made in writing to the Secretary and then delivered to the office of the department. The procedure (AG, 2020) -

  • The applicant must give the prescribed fee.
  • The form to be in the said manner as specified by the Secretary.
  • If the medicine is a restricted one, then the application must mention the details of the product under section 7D.
  • If the secretary wishes, he can demand samples of the goods.

I would choose this route as it is specified under the act and is a legal procedure to apply for registration.

Prescribing Information for Australia - Question 3

The three scientific level and claims under the Therapeutic Goods Act, 1989 are (AG, 2011)-

  • Sponsors must have some credible evidence to support their claims.
  • Claim made must be true and not be misleading or false.
  • The claim must nowhere incline any unsafe or inappropriate use of the product.

The above claims can only be supported by either traditional evidence or scientific evidence.

Prescribing Information for Australia - Question 4

These schedules are categorized into 10 categories (AG, 2020)-

Schedules

Specifications

Schedule 1

Not currently in use

Schedule 2

Pharmacy medicine

Schedule 3

Pharmacist only medicine

Schedule 4

Prescription-only medicine OR prescription animal remedy

Schedule 5

Caution

Schedule 6

Poison

Schedule 7

Dangerous poison

Schedule 8

Controlled drug

Schedule 9

Prohibited substance

Schedule 10

The substance of danger to health as to warrant prohibition of sale, supply and use.

These are published in Poison Standard and given accreditation only after state or federal legislation.

Prescribing Information for Australia - Question 5

A clear piece of work is expected from a scientific writer as his piece is supposed to be informative and persuasive. It should be informative because he has to impart the procedure of his research and persuasive because the writer has to convince his readers that the conclusion drawn from his research is adequate to the principles (EWU, 2020).

References for Prescribing Information for Australia

Grove, A. (2019). Therapeutic goods: A quick guide. Retrieved from https://www.aph.gov.au/About_Parliament/Parliamentary_Departments/Parliamentary_Library/pubs/rp/rp1819/Quick_Guides/TherapeuticGoods

Australian Government. (2020). What are 'therapeutic goods'? Retrieved from https://www.tga.gov.au/what-are-therapeutic-goods

Australian Government. (2020). Administrative information and prescribing information for Australia - Applicable to applications received by the TGA from 9 February 2018. Retrieved from https://www.tga.gov.au/ctd-module-1

Australian government. (2011). Guidelines for levels and kinds of evidence to support indications and claims for non-registerable medicines, including complementary medicines, and other listable medicines. Retrieved from https://www.tga.gov.au/sites/default/files/cm-evidence-claims-1104.pdf

Australian Government. (2020). Scheduling basics. Retrieved from https://www.tga.gov.au/scheduling-basics

Eastern Washington University. (2020). Scientific writing. Retrieved from https://research.ewu.edu/writers_center_sci_writing#:~:text=To%20avoid%20confusing%20the%20reader,helps%20the%20writer%20accomplish%20this.

Remember, at the center of any academic work, lies clarity and evidence. Should you need further assistance, do look up to our Law Assignment Help

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