COVID-19 (Coronavirus) News:
Coronavirus Information for New Zealand Exporters
NZ Trade & Enterprise have added a page on novel coronavirus to their website where you can find useful information for exporters. Source: NZ Trade & Enterprise
COVID-19 Point-of-Care Tests
Point-of-care COVID-19 serology tests detect human antibodies produced in the days after a person is infected with the SARS-CoV-2 virus. These tests are usually presented in a small plastic cartridge, similar to pregnancy tests, and require a blood specimen for testing. Currently, several COVID-19 point-of-care tests have been approved by the Therapeutic Goods Administration (TGA) subject to conditions, including restrictions on who can obtain them. The TGA urges everyone who is considering offering a COVID-19 point-of-care testing service to visit this site and read the following information: TGA Covid19-point of care tests
TGA Investigating $15,000 product Pete Evans Claims Fights COVID-19
A $15,000 device that controversial celebrity chef Pete Evans has spruiked is under investigation. Evans claimed the light frequency machine can fight the deadly coronavirus. Evans plugged the product – The “BioCharger” – to his Facebook followers recently, claiming it could treat a range of ailments, including COVID-19. He described the product, which is listed for sale on his website, as a “pretty amazing tool” which he and his family “use pretty much every day”. Source: Rebekah Scanlan, News.com.au Amazing tool
CK Surgitech Fined $25,200 For Alleged Breaches in Relation to COVID-19 Test Kits
The TGA has issued two infringement notices totalling $25,200 to Queensland company CK Surgitech Pty Ltd for alleged breaches of the Therapeutic Goods Act 1989 (the Act). It is alleged the company made a false or misleading statement in an application to have their IVD Rapid Test kits for SARS-CoV2 (the COVID-19 virus) included in the Australian Register of Therapeutic Goods (ARTG). The company also allegedly breached a condition of the Therapeutic Goods (Medical Devices - Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020 (the Exemption) by importing COVID-19 test kits that were not included in the ARTG and were not being imported in relation to an authorised pathology laboratory as required by the Exemption. Source: Virus test fail
Depleting Stocks, Longer Delivery Time: Companies on Meeting Vitamin C Supply Amid COVID-19 Disruption
The huge demand for vitamin C has sent stocks running low for retailers and the situation is further complicated by longer delivery times and more expensive freight costs. Source: (Copyright) Tingmin Koe, FoodNavigator-Asia Vit C shortage
Exemption to Enable the Domestic Manufacture and Supply of Ventilators
The Australian Government has moved to facilitate access to medical devices to treat patients requiring invasive ventilation. The new emergency exemption is in effect until 31 January 2021 and is applicable to ventilators that are not already included on the Australian Register of Therapeutic Goods (ARTG) in the name of the manufacturer and can demonstrate compliance with minimum technical requirements. The exemption does not permit the general supply of these ventilators to healthcare facilities or consumers outside the context of the COVID-19 emergency. Source: Australian ventilator manufacture
TGA Update: Domestic Good Manufacturing Practice (GMP) Inspections During the COVID-19 Pandemic
The TGA has developed new arrangements to allow continued and flexible oversight of Good Manufacturing Practice (GMP) at licenced domestic manufacturing sites during the COVID-19 pandemic. The TGA has developed a process to enable inspectors to undertake remote and/or hybrid GMP domestic inspections where suitable, in place of on-site inspections. The TGA will only use this process during the COVID-19 pandemic. Routine on-site inspections will recommence at an appropriate time when the pandemic restrictions are lifted. Source: GMP inspections
Complementary Medicines (‘Dietary supplements’):
Guidance for Sponsors Exporting Therapeutic Goods
To export therapeutic goods from Australia for commercial purposes, you must meet certain regulatory requirements set out in the Australian therapeutic goods legislation. The goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before you can legally export them, unless they are exempt from being entered in the ARTG. Every ARTG entry belongs to a 'sponsor' who is responsible for applying for and maintaining the ARTG entry. If you are planning to export a therapeutic good for commercial supply overseas, you must be the sponsor named in the ARTG entry for that good, or an authorised agent acting on behalf of the sponsor. Source: Therapeutic goods export
TGA Approved Terminology for Therapeutic Goods
The Therapeutic Goods Administration (TGA) develops and maintains approved terminology to ensure the accuracy and consistency of information on the Australian Register of Therapeutic Goods (ARTG). The latest PDF update on Approved Terminology can be downloaded here: TGA approved terminology
Consultation: Proposed amendments to the Poisons Standard Include Cannabidiol (CBD)
The TGA has requested feedback form interested parties after it was proposed to alter the Poisons Standard to down-regulate the rules related to the supply of several different medications, including Cannabidiol (CBD). If the proposed regulatory changes are accepted, it is expected that from 2021 certain CBD products will have increased consumer access and be able to be purchased without a prescription. There are two consultations currently open, each seeking public submissions on what form this consumer access may take. The Australian Government is proposing low-dose access via Pharmacists only. A private applicant is proposing wider consumer access. These two related consultations will result in only one final decision on CBD access and will consider public submissions and expert Committee advice. The due date for both cannabidiol consultations is close of business 22 May 2020. Source: CBD consultation
Reminder - Updating Ingredient Names for Complementary Medicines – Transition Ends 30 April 2020
In 2017 the TGA commenced a program to harmonise medicine ingredient names. This transition period for updating medicine names ends on 30 April 2020, which means that all medicines released for supply after this date must carry the updated ingredient names. The TGA have contacted affected sponsors and released an affected ingredients list. Sponsors need to be aware of which medicines will be affected by these changes and to ensure that all labelling and promotional materials are compliant by 1 May 2020. If you are a sponsor of CMs, you should be asking yourself the following questions:
- Do I have a medicine that contains an ingredient on the affected ingredients list?
- If an active ingredient is affected, is the right name displayed on the labels?
- If an excipient ingredient is affected, and the excipient is declared on the labels, is the right name (including spelling) displayed on the labels?
- If the medicine has an associated product information document, is the right ingredient name used?
- If you have advertising materials for your medicine that include ingredient names, is the rightingredient name used in all of those materials? Sources: Updating ingredient names & Affected ingredients list
Medical Device Labelling Obligations
All medical devices supplied in Australia must meet the relevant Essential Principles for safety and performance to ensure the device is safe and performs as intended. This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations. The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device. The person legally responsible for including a medical device on the Australian Register of Therapeutic Goods (ARTG), is referred to in the legislation as a 'Sponsor'. Source: Medical device labelling
ATP Science Fined $302,400 for Advertising Breaches
The Therapeutic Goods Administration (TGA) has issued ATP Science Pty Ltd (ATP Science) with 24 infringement notices totalling $302,400. The infringement notices are for the alleged advertising of several therapeutic goods not included in the Australian Register of Therapeutic Goods (ARTG). The TGA alleges that ATP Science made several claims in relation to the goods, including prohibited representations relating to cancer and the treatment of mental health conditions, along with restricted representations. The use of prohibited and restricted representations in advertisements for therapeutic products is unlawful without the express permission of the TGA. Source: ATP advertising fail
Failing Food Report – February 2020
These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of February. Among the usual pathogenic organisms detected in these imported foods are such organisms as Salmonella (found in various Asian spices), and assorted toxins such as histamine (found in Thai and Vietnamese fish and spice pastes), aflatoxin (found in Turkish peanuts and Thai spice paste), antibiotics (found in Thai dried fish) and others. Of particular note are the number of foods ‘failing’ due to the illegal presence of heavy metals (including lead) and added vitamins and or minerals (found in many foods). Source: February 2020 food fails
Proposal P1050 – Pregnancy warning labels on alcoholic beverages: This is a summary of this proposal aiming to better inform pregnant women of the dangers of drinking alcohol. Source: Alcohol warning statement
Application A1196 – Food derived from nematode-protected and herbicide-tolerant soybean GMB151: The purpose of the application is to seek approval for food derived from nematode-protected and herbicide-tolerant soybean line GMB151, genetically modified to provide resistance to nematodes and the HPPD group of herbicides. Source: GM soybeans
Cosmetics and TGA Listed Sunscreens:
Reminder: NICNAS Turns into AICIS on 1 July 2020 – Training Videos Available
Regular readers of this newsletter will be aware that the regulation of the chemical ingredients used in cosmetics, has been controlled by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), and that this is to change when the new regulatory framework for industrial chemicals will be called the Australian Industrial Chemicals Introduction Scheme (AICIS) commencing on 1 July 2020. Due to the absence of face to face training while the Coronavirus pandemic rages, NICNAS has provided several short videos covering different elements of the new scheme. These video sessions are each 25 minutes long. Copies of the slides and presentations can be read and downloaded here: NICNAS to AICIS videos
Training: RFA Provides Comprehensive Training in Regulatory Affairs
COVID-19 (Coronavirus) update:
In order to protect the integrity of our company so that we can continue to provide you with regulatory advice, our technical team members are now working remotely from our office, and we have cancelled all face to face meetings and training sessions at our office.
We are still operating during normal business hours, communicating via emails and conducting training courses via Skype (www.rfareg.com/training-courses ). Throughout this community health crisis, we continue to offer regulatory support remotely - no need to visit our office! – via skype or phone call – as well as international advice with no need for physical contact.