TGA to Change Online Listed Medicine Applications Process

The Therapeutic Goods Administration intends to remove the “free text” indication field which is currently available for online Listed Medicine applications. This field enables you to enter the wording you would like for product claims. The only indications that may be included in TGA product listing applications from 1st January 2018, will be from a database of permitted indications and the wording is specified. There will be a 3 year transition period to re-list products using only the permitted indications. From 1st January 2021, listed medicines will only be able to contain permitted indications. There will be no TGA fee for re-listing with permitted indications if sponsors re-list between 1st January 2018 and 30th June 2019. The AUST L number will remain the same.

What needs to be done now?  The TGA proposed permitted indications list is available on the TGA website for comment until 31st October 2017, and sponsors can apply to have new indications included in this list without any TGA fees. After this date, an application fee will apply. If you cannot find the indications for a product that is an existing Listed Medicines on the Australian Register of Therapeutic Goods on the list we suggest you submit your proposed indications to the TGA during the fee-free period, or RFA Regulatory Affairs can assist with applying for the indications to be included in the permitted indications list. Let us know!    Source: RFA Regulatory Affairs – Technical Report

TGA Provides Guidance on Pre-submission Meetings

This guidance is for applicants (sponsors, manufacturers and agents) preparing for pre-submission meetings related to applications to enter therapeutic goods on the Australian Register of Therapeutic Goods (ARTG); and for TGA Conformity Assessment Certification (for the manufacture of medical devices). It does not apply to applications for a manufacturing licence or Good Manufacturing Practice certification or clearance.    Source: TGA pre-meetings

TGA Provides Guidance on the Regulation of Tampons in Australia

Tampons are therapeutic products which are regulated as 'Other Therapeutic Goods'. Before they can be supplied in Australia, they must be listed on the Australian Register of Therapeutic Goods (ARTG). Tampons supplied in Australia must comply with Therapeutic Goods Order No.82 - Standard for Tampons - Menstrual. This aims to ensure that tampons are manufactured in a manner that will minimise recognised risks to health associated with the use of these products.    Source: Tampons

TGA Changes Ruling on Vitamin A – Beta Carotene Naming

Did you know that a Listed Medicine label can now refer to the retinol equivalents of betacarotene?  They can! The maximum daily dose of 3000 RE/microgram of vitamin A does not apply to this source of vitamin A and the TGA has advised that this is due to the unique action of betacarotene (where it is converted in the body to vitamin A selectively, depending on reserves of vitamin A). In the case of a combination product that contains betacarotene and another source of vitamin A, the dose of the other sources of vitamin A may not exceed 3000 RE/microgram, however the addition of betacarotene does not contribute to this quantity. Currently, in the Permissible ingredients determination 26BB, if vitamin A is declared as an equivalent of betacarotene, then the VITA3 and VIT warnings are required on the product label and the equivalent vitamin A should be expressed in the relevant R.E. units. The TGA have advised that the requirement for the VIT warning will be removed from betacarotene in the October 2017 update to the Permissible Ingredients Determination. As you are not required to declare the vitamin A content of betacarotene, it is also not a requirement to declare its quantity on the label even if it is included on the Australia Register of Therapeutic Goods entry for the product. If you would like your label reviewed or more advice on betacarotene or Vitamin A, get in contact with RFA. This is a significant policy change from the TGA, as previously betacarotene could not be stated in retinol equivalence Source: RFA Regulatory Affairs – Technical Report

TGA Announces Labelling Changes: Information for Health Professionals

The TGA has introduced improvements to help bring Australian medicine labels up to date and align them with international best practice. They will help Australians to make more informed choices about their medicines and to use them more safely.    Source: Label changes

TGA Addresses Issues Related to Supply of Medicinal Cannabis in Australia

The (recent ABC) Lateline story made claims that patients are turning to the black market for medicinal cannabis products because of excessive red tape, principally in seeking approvals under the Special Access Scheme Category B. This scheme has operated for many years and the TGA provides over 20,000 approvals per year for doctors to prescribe a range of unregistered medicines. The TGA claims that the approval system can and does work efficiently to meet the needs of patients so why are prescription levels for medicinal cannabis products relatively low? The Lateline story itself provided the answer. One of the interviewees, Justin Sinclair, stated, 'There is a great paucity of evidence in the literature, at least when it comes to human trials'.    Source: Medicinal cannabis      Editor’s note: See also related stories from TGA Presentations: Legislation and patient access schemes for medicinal cannabis ; &, Medicinal cannabis cultivation and manufacture update

TGA Safety Advisories

Bittermelon Slimming Capsules; Herbal Max Real Slim Capsules; Majestic African Mango capsules: the capsules contain the undeclared substance sibutramine &/or phenolphthalein.

Germany Black Gorilla tablets; Maxidus capsules; Rhino 9 capsules: the tablets contain the undeclared substance sildenafil.  

M Distribution - male herbal supplements: M Distribution, in consultation with the TGA, has initiated a recall of Oh Baby! capsules, JO LMax Extra tablets and RUFF Natural Formula 10,000 mg capsules as they contain tadalafil, dimethylaminoethanol (DMAE or Deanol), &/or sildenafil and dapoxetine.

Source: TGA alerts

 

RFA Breaking News

This issue of RFA Newsletter is sponsored by

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