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October 2020

BEAST Natural Formula 41,000 MG capsules

27 October 2020

BEAST Natural Formula 41,000 MG capsules pose a serious risk to your health and should not be taken
H.R.D. Tablets

27 October 2020

H.R.D. Tablets pose a serious risk to your health and should not be taken
KANGAROO 2019 Mega 3000 tablets

27 October 2020

KANGAROO 2019 Mega 3000 tablets pose a serious risk to your health and should not be taken
SCORPION Natural Formula 41,000 MG capsules

27 October 2020

SCORPION Natural Formula 41,000 MG capsules pose a serious risk to your health and should not be taken
Notification of a new proprietary ingredient

27 October 2020

Updated form used to notify the TGA of proprietary ingredient mixtures for use in therapeutic goods
Database of section 19A approvals to import and supply medicines to address medicine shortages

27 October 2020

Section 19A database has been updated to include new approvals
Pharmacist fined $2,664 for alleged unlawful importation of medical face masks in relation to COVID-19

23 October 2020

The TGA has issued an infringement notice for $2,664 to a Sydney-based pharmacist
Livingstone International fined $13,320 for alleged unlawful importation of infrared thermometers

23 October 2020

The TGA has issued an infringement notice for $13,320 to Sydney-based company Livingstone International Pty Ltd
Simply Elements fined $13,320 for alleged unlawful importation of surgical face masks in relation to COVID-19

23 October 2020

The TGA has issued an infringement notice for $13,320 to Melbourne-based company Simply Elements Pty Ltd
Truvelog

23 October 2020

TGA decision: Truvelog (insulin aspart) is approved to treat diabetes mellitus
Shortage of Brevinor and Norimin (ethinylestradiol/norethisterone)

23 October 2020

Update - Alternative products approved to address shortages
Listed medicines containing Artemisia species

23 October 2020

Safety advisory - potential risk during pregnancy
Information Webinar: Proposed changes to the way nicotine is supplied

22 October 2020

Webinar presentation, recordings and frequently asked questions
Update on nicotine scheduling and proposed restriction on importation of nicotine for use in e-cigarettes

22 October 2020

Pending the final outcome of the process required by law, it has been decided to defer the proposed restriction on importation of nicotine for use in e-cigarettes and, separately, e-cigarette devices
AusPAR: Vonicog alfa

21 October 2020

Australian Public Assessment Report for Vonicog alfa
AusPAR: Venetoclax

21 October 2020

Australian Public Assessment Report for Venetoclax
AusPAR: Gemtuzumab ozogamicin

20 October 2020

Australian Public Assessment Report for Gemtuzumab ozogamicin
IMDRF consultation: Proposed update to document on Post-Market Clinical Follow-Up Studies

20 October 2020

The TGA (together with all other working group members) invite interested parties to comment on the document. Closing date: 11 December 2020
Information for medical practitioners on pending up-classification of surgical mesh devices

20 October 2020

Important information on the up-classification of new surgical mesh devices with effect from 1 December 2020 and 1 December 2021
Information for Australian manufacturers of medicinal cannabis products

20 October 2020

Information on expectations for licensing authorisations and conditions
Listed medicines at risk of containing safrole

20 October 2020

The TGA has initiated compliance reviews of a selection of listed medicines at risk of containing safrole
Webinar: Proposal to implement an active surveillance program to validate sponsors' medical device post market regulatory obligations - Proposal 3 - Industry and Consumers

19 October 2020

Webinar series: Proposal to implement an active surveillance program to validate sponsors’ medical device post market regulatory obligations - Industry and Consumers
Webinar: Proposed enhancement to adverse event reporting for medical devices - Proposal 1, 2, 4 and 5 - Consumers

19 October 2020

Webinar series: Proposal to implement an active surveillance program to validate sponsors’ medical device post market regulatory obligations - Consumers
Webinar: Post Market Review Compliance Dashboard information sessions

19 October 2020

New webinar: Post Market Review Compliance Dashboard information sessions
Phenelzine (Nardil)

19 October 2020

Alternative product approved to address discontinuation
Tranylcypromine (Parnate)

19 October 2020

Alternative product approved to address expected shortage
New compliance dashboard for post-market medical device reviews

19 October 2020

Changes to the process for responding to post market reviews
Laparoscopic power morcellators - Update 3

16 October 2020

Update 3 - Further review underway
Valerian (Valeriana officinalis)

15 October 2020

Safety advisory - potential for liver injury
Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices

15 October 2020

We invite sponsors of Class I medical devices to provide their feedback on the changes by answering an online survey
TGA grants second provisional determination for a COVID-19 vaccine

14 October 2020

The TGA has granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, BNT162b2 [mRNA]
The ACSS Consortium welcomes the UK as its newest member

14 October 2020

The heads of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium are pleased to announce that the MHRA is joining as a new member
The TGA's approach to delays in medical device conformity assessment recertification

13 October 2020

Due to COVID-19 pandemic and delays in EU MDR implementation
Frequently asked questions about Authorised Prescribers

13 October 2020

Answers to questions about Authorised Prescribers
Authorised Prescriber Scheme

13 October 2020

Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors
YongGang tablets

12 October 2020

YongGang tablets pose a serious risk to your health and should not be taken.
Is your advertising for therapeutic goods compliant?

12 October 2020

Before you advertise therapeutic goods, it is your responsibility to ensure the advertising complies with the legislative requirements
TGA grants provisional determination for COVID-19 vaccine

9 October 2020

The TGA has granted a provisional determination to AstraZeneca Pty Ltd in relation to its COVID-19 Vaccine, ChAd0x1-S [recombinant]
Cat Media fined $13,320 for alleged unlawful advertising

9 October 2020

The TGA has issued an infringement notice totalling $13,320 to Sydney-based company Cat Media Pty Ltd for alleged advertising breaches
Rymti, Etera

9 October 2020

TGA decision: Rymti, Etera (etanercept) is approved to treat rheumatoid arthritis and certain other inflammatory conditions.
AIVC recommendation for the composition of influenza vaccine for Australia in 2021

9 October 2020

AIVC introduces two new influenza strains for the 2021 influenza vaccine
New transparency measures for prescription medicines

9 October 2020

The Australian Government has given approval to proceed with two measures to enhance transparency for prescription medicines
Submissions received and TGA response: Transparency measures for prescription medicines

9 October 2020

The TGA would like to thank respondents who provided submissions in response to the March 2020 targeted consultation paper
Shen Neng Herbal Medicines Group fined $100,800 for alleged breaches of therapeutic goods legislation

9 October 2020

The TGA has issued eight infringement notices to Sydney-based company Shen Neng Herbal Medicines Group Pty Ltd in relation to supply, labelling and pharmacovigilance
PharmaCare Laboratories fined $164,520 for alleged misleading advertising of complementary medicines

9 October 2020

The TGA has issued 13 infringement notices to Sydney-based company PharmaCare Laboratories
Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil

9 October 2020

Update - Infringement notices issued
Changing sponsor details in Product Information (PI) and labels of prescription medicines

8 October 2020

This guidance describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines
Restricted representation application checklist

8 October 2020

New compliance checklist for advertisers
Guidance for submitting an application for approval to use a restricted representation

8 October 2020

Guidance has been updated
Maxman XI tablets

7 October 2020

Maxman XI tablets pose a serious risk to your health and should not be taken
Prescription medicines: registration of new chemical entities in Australia

6 October 2020

4 medicine registrations added
Prescription medicines: new or extended uses, or new combinations of registered medicines

6 October 2020

3 medicine registrations added
Prescription medicines: registration of new generic medicines and biosimilar medicines

6 October 2020

9 medicine registrations added
Ongentys

6 October 2020

TGA decision: Ongentys (opicapone) is approved as adjunctive therapy in adult patients with Parkinson's disease.
Prescription opioids: Information for health professionals

2 October 2020

New clinician information sheets on opioid analgesic tapering
The Poisons Standard (the SUSMP)

1 October 2020

The new edition of the SUSMP has been registered on the Federal Register of Legislation (FRL) as Poisons Standard October 2020

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URL:https://www.tga.gov.au/node/3394

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