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Australian Register of Therapeutic Goods (ARTG) results

The ARTG is a register of therapeutic goods that can be lawfully supplied in Australia. More...

Dentsply Sirona Pty Ltd - Jaw physiology evaluation system
ARTG ID: 290955
Dentsply Sirona Pty Ltd
Cochlear Ltd - Cochlear implant system evaluation application software
ARTG ID: 282637
Cochlear Ltd
Cochlear Ltd - Cochlear implant system evaluation application software
ARTG ID: 282636
Cochlear Ltd

More results from the ARTG ▸

Website results

These results do not include items from TGA's databases, such as the Database of Adverse Event Notifications, the System for Australian Recall Actions and Medicines Shortages Information.

1 - 15 of 742 search results for evaluation fees

  1. Fees and payments

    https://www.tga.gov.au/fees-and-payments

    The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities

  2. Guidance 2: Fees and charges for prescription medicines: 2.3 When to…

    https://www.tga.gov.au/book/23-when-pay-application-and-evaluation-fees-prescription-medicines

    9 Sep 2014: The TGA issues invoices for the evaluation fees only. The evaluation fee must be paid within two months of its due date or the application will lapse. ... the remaining evaluation fee equivalent to 80 per cent of the total fees should be paid when the

  3. OTC new medicines registration process: Step 8 - Paying your fees

    https://www.tga.gov.au/book-page/step-8-paying-your-fees

    Waive or reduce evaluation fees. For applications that are not eligible for concurrent fees, in some circumstances we may be able to waive or reduce the evaluation fee (not the application ... include cheque or credit card details with the submission.

  4. Refunds

    https://www.tga.gov.au/refunds

    7 Mar 2017: Evaluation fees are non-refundable following acceptance by the TGA, unless the applicable fee has been waived or reduced after payment has been made ( see below). ... Evaluation fees. Evaluation fees are non-refundable following acceptance by the TGA,

  5. Regulation of biosimilar medicines

    https://www.tga.gov.au/publication/evaluation-biosimilars

    17 Dec 2015: Evaluation. UPDATED. Biosimilars are evaluated via the prescription medicines registration process and applications need to meet the same requirements and guidelines as those for prescription medicines including:. ... Application and evaluation fees for

  6. ARGPM Appendix 2: Fees and charges

    https://www.tga.gov.au/sites/default/files/pm-argpm-ap02.docx

    16 Jul 2013: Category 1 and 2 applications: 75% of the evaluation fee is be payable when the application is submitted. ... If the application is withdrawn or rejected before it is accepted for evaluation, a screening fee applies (see TGA website for details of

  7. Guidance 2: Fees and charges for prescription medicines: 2.7 When…

    https://www.tga.gov.au/book/27-when-evaluation-fees-are-waived-or-reduced-prescription-medicines

    9 Sep 2014: Book pagination. 9 September 2014. 2.7 When evaluation fees are waived or reduced for prescription medicines. ... Application and evaluation fees can be waived or reduced under the following circumstances, as prescribed by the Regulations.

  8. Upgraded over-the-counter medicines online application system

    https://www.tga.gov.au/media-release/upgraded-over-counter-medicines-online-application-system

    8 Apr 2014: With the introduction of the upgraded portal, a target time of 60 working days will be introduced for the initial evaluation of C2 type applications. ... These are explained fully on page 15 ('Fees') in an update to the ARGOM: Guidelines for the

  9. Meeting your obligations

    https://www.tga.gov.au/sme-assist/training-sessions/meeting-your-obligations

    9 Jun 2017: your legal and financial responsibilities, including:. fees and charges; for example, application and evaluation fees or fees for inspections.

  10. Orphan drugs

    https://www.tga.gov.au/orphan-drugs

    28 Jun 2017: Designated orphan drugs are eligible for a waiver of their application and evaluation fees, but only if designation is received prior to submitting an application to register an orphan drug on ... Diagnosis of neural crest tumours, including those

  11. Guidance 2: Fees and charges for prescription medicines: 2.8 When…

    https://www.tga.gov.au/book/28-when-application-fees-are-refunded-prescription-medicines

    9 Sep 2014: 24D of the Act and r. 43AA. Please note that these provisions only relate to the evaluation fee and not the application fee. ... The full application fee will be retained by the TGA. There is no reduction in evaluation fee for other applications that

  12. Fees and charges: summary - from 1 July 2017: Biologicals

    https://www.tga.gov.au/book-page/biologicals-0

    28 Jun 2017: $6, 500. Item 9. Class 3 biological - evaluation fee for inclusion in ARTG. ... $141, 700. Item 5. Class 4 biological - evaluation fee for inclusion in ARTG.

  13. ARGCM Part I: Registration of Complementary Medicines

    https://www.tga.gov.au/sites/default/files/cm-argcm-p1-110825.docx

    13 Dec 2013: Evaluation fees are payable for all Registration evaluations. The fee payable depends on the number of pages of clinical and toxicological data supplied. ... Invoice raised for application fee and evaluation fee (based on clinical/toxicological page count

  14. Priority review registration process

    https://www.tga.gov.au/publication/priority-review-registration-process

    7 Jul 2017: Application and evaluation fees. Application and evaluation fees are higher for the Priority Review registration process than the standard prescription medicines registration process. ... The fee amounts are available at the fees and payments section of

  15. Medical devices & IVDs

    https://www.tga.gov.au/medical-devices-ivds

    9 Jun 2017: Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic

  16. Overview of applying for market authorisation

    https://www.tga.gov.au/sme-assist/overview-applying-market-authorisation

    9 Jun 2017: Sometimes you'll need to pay an additional evaluation or assessment fee to cover the cost of us assessing your therapeutic good. ... The TGA has both fees and charges. A fee is charged for a service, such as an evaluation/assessment.

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