current affairs

Regulatory News. Issue 228. July – August 2022

Note from the editor, Robert Forbes. This is the first edition of Current Affairs to be published by Regulatory Training Direct Pty Ltd. As mentioned in the previous newsletter, as of the 1st July 2022, RFA Regulatory Affairs became part of DTS Regulatory Consultants. I am no longer providing regulatory affairs consulting advice. For regulatory affairs advice please email David Dwyer (david@dtsreg.com.au +61 7 3390 8777). The world famous vitamin converter we developed many years ago is now on the DTS website here.

Regulatory Training Direct is a new company offering the same courses as were offered previously by RFA Regulatory Affairs. Abbie Harris, a product development specialist, and I are the directors of the company. The courses can be viewed at www.regulatorytrainingdirect.com . We will be adding additional courses for Australia, New Zealand, USA, Canada and UK regulations, as well as product development courses. Stay tuned!

Pharmacovigilance course: The TGA is now enforcing this responsibility and several companies have already been fined for not fulfilling their responsibilities. This course, conducted face to face by appointment via Zoom, includes a set of 18 forms and procedures that you can use to ensure you comply with your obligations. The course is conducted by Quentin Blades who was involved in the first PV audit the TGA undertook of a sponsor of listed complementary medicines, read more.

Click the button below to book this course.

Complementary Medicines and Medical Devices:

NOTE: while this newsletter was being created the TGA website was changed, so some of the links below may not work as they don’t seem to have been redirected to the new site. If you need more details of one of these articles please contact us and we maybe able to help.

New TGA Website this webinar presentation from July explains the changes on TGA website, available here

Revised list of ingredients permitted in listed complementary medicines. 32 changed ingredients – three are additions (EPA-rich Nannochloropsis oculata oil, Vanillin acetate and (-)-Menthyl methyl ether) one has been deleted (Methyl methacrylate) and the others have been changed in some way. Source: TGA

Proposed changes to the Permissible Ingredients Determination. Warning statement: healthcare professional supervision for the ingredients Chelidonium majus and Larrea tridentata andliver injury associated with Valeriana officianalis. Interested parties must respond by close of business Thursday 15 September 2022. Source: TGA

Webinar presentation: Unique Device Identification No. 10 – Accessing and using the Australian UDI database ‘Sandpit’ – presented by TGA in June and available here.

Proposed Australian medical device UDI regulatory framework. TGA invitation to review the third consultation paper. Closing date 11^th October. Source: TGA

The TGA business plan 2022-23 was released recently but since the TGA site has changed we cannot find it even after searching the TGA site. If you want to see it we suggest you contact the TGA.

Guidance on applying the Advertising Code rules. A lengthy and comprehensive document and a must read for all suppliers of nonprescription medicines including complementary medicines, and medical devices – available on TGA website here.

Meeting your obligations – Workshop – 20 September 2022 – a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation. Source: TGA

Proposed amendments to the Poisons Standard. Including azelastine and fluticasone propionate, cannabis and tetrahydrocannabinols, lead, meloxicam, lidocaine, flumioxazin. Source: TGA

Other proposed amendments include Ivermectin, brimonidine, fexofenadine, ibuprofen, melatonin, green tea extract, ethalfluralin, tigolaner. Source: TGA

Update to GMP for medicines, APIs & sunscreens. TGA adopted the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-15) issued, 1 May 2021, as the Manufacturing Principles for medicines, active pharmaceutical ingredients and sunscreens. The main changes relate to biological medicines. Source: TGA

Safety warning – experts advise against using “first generation” antihistamines in young children for cough, cold and flu symptoms. Nine active ingredients in this class listed on TGA website here.

TGA’s Import, Advertising and Supply Compliance Priorities 2022-23 – summarised in table format here

Active medical devices are devices that use energy to operate. Guidance on the requirements that specifically apply to these devices. Source: TGA

Safety alert: Penisole capsules (ayurvedic medicine). Penisole is not included on the Australian Register of Therapeutic Goods so cannot be legally supplied in Australia, however it is available online. Penisole is labelled to contain the ingredient Trivang bhasma (also known as Trivanga bhasma) which is a combination containing Naga (lead), Vanga (tin) and Yashada (zinc). Taking Penisole could result in lead poisoning, a serious condition that can cause long-term health effects, including organ damage and death. Pregnant women and children are at a greater level of risk of lead poisoning. Source: TGA

Product recalls

Lucas’ Papaw Ointment Consumer Level Recall – Potential microbial contamination of certain batches. Source: TGA

Global operation tackling illicit and counterfeit therapeutic goods. The TGA joined 94 countries in INTERPOL’s Operation Pangea and intercepted more than $2 million of illegally imported products. Source:TGA

Compliance enforcement

• Strapit Medical and Sports Supplies received two infringement notices totalling $26,640 plus a court enforceable undertaking in relation to alleged advertising breaches that implied face masks advertised on their website were approved by the TGA however the advertising referred to two cancelled ARTG entries. Source: TGA
• Federal Court proceedings have commenced against Vapor Kings and its sole director, Amir Kandakji, for alleged unlawful advertising of nicotine vaping products, which continued to be advertised for some months after they received warnings. Source: TGA
• 12 infringement notices totalling $31,698 issued to a NSW based individual for alleged unlawful advertising of disposable nicotine vaping products on several websites. After receiving warnings, the individual attempted to evade responsibility by closing the original websites and publishing further advertising on two new websites. Source: TGA
• Precision Pharmaceuticals issued two infringement notices totalling $26,640 and directed to cease alleged unlawful advertising of nicotine vaping products. Source: TGA
• Doughbot Enterprises and Officer fined $87,312 for alleged advertising of nicotine vaping products on websites and social media. Source: TGA
• $2,664 infringement notice issued to a WA-based individual for allegedly importing liquid nicotine for use in nicotine vaping products. Source: TGA
• The Federal Court of Australia has ordered Enviro Tech Holdings Pty Ltd to pay $80,000 for unlawful importation of surgical face masks. As the company did not pay a previous fine of $13,320 court proceedings were commenced. Source:TGA
• 2San Pty Ltd fined $66,600 for allegedly failing to provide ongoing evidence to support the performance of its COVID-19 rapid antigen tests. The company had been issued multiple infringement notices for serial non-compliance in not meeting deadlines and were contacted on several occasions. Source:TGA
• $2,664 infringement notice issued to a NSW-based individual for allegedly continuing to advertise nicotine vaping products for sale via their website even after being informed about the law for prescription medicines. Source: TGA
• Cyclotek Queensland fined $93,240 for allegedly breaching conditions of its manufacturing licence. Cyclotek manufactures radiopharmaceuticals and a recent GMP inspection by the TGA of Cyclotek Queensland identified unacceptable serious manufacturing practices. Source: TGA
• Shen Neng has undertaken to address non compliance issues including the failure to include mandatory warning and other statements on the labels of medicines, making an incorrect statement to the TGA, in connection with an application for listing of goods, incorrectly certifying that medicines containing methyl salicylate contained the appropriate label warnings, the failure to comply with record keeping and reporting requirements and the requirement to comply with the Pharmacovigilance Responsibilities of Medicines Sponsors including Shen Neng nominating a pharmacovigilance contact person in respect of its medicines; and the failure to notify the TGA of certain information concerning adverse effects.

Foods:

FSANZ work plan. Food Standards Development work, as of 22^nd August. Source: FSANZ

Public consultations that are still open.

Application A1220 – Beta-amylase from GM Bacillus licheniformis as a processing aid closes 13^th September.

Phospholipase A1 from GM Aspergillus niger as a processing aid closes 6pm (Canberra time) 13 September 2022.

Glucose oxidase from Penicillium rubens as processing aid Submissions close 6pm (Canberra time) 13 September 2022.

Source: FSANZ news

Approvals – variations arising from applications and proposals

Composition and Labelling of Electrolyte Drinks

Primary Production and Processing Requirements for Horticulture (Berries, Leafy Vegetables and Melons)

Serine endopeptidase enzyme from GM Trichoderma reesei

Chymosin from GM Trichoderma reesei as a processing aid (enzyme)

Source: FSANZ news

Food Recalls – source: Food Authority NSW

Herbie’s Spices – Raita Spice Blend, Chaat Masala, Black Salt – presence of undeclared allergens (peanuts and tree nuts).

Harris Smokehouse – Hot Smoked Barramundi, Hot Smoked Trout Blackening Spice, Everyday Smashed Smoked Salmon, Premium Smoked Salmon, Smoked Salmon Trimmings – possible Listeria monocytogenes contamination.

Reese’s Dipped Pretzels – presence of an undeclared allergen (peanut).

Powered by Plants – Cleanfit​ Plant Protein Bar Chocolate Brownie – presence of an undeclared allergen (milk).

General Mills Australia – Häagen-Dazs Vanilla ice cream and Häagen-Dazs Classic Collection Mini Cups ice cream – due to chemical (ethylene oxide) contamination.

Coles Supermarkets – Coles Tomato Paste – presence of an undeclared allergen (soy).

Food recalls – source: FSANZ

Eagle Bay Brewing Company – excess alcohol and carbonation may cause illness/injury if consumed.

Raw Nation Wholefoods  – Crudo Cheekie Pumpkin, Crudo Chicken Caesar, Crudo Vietnamese Bowl, Crudo Jamaican Jerk, Crudo Oriental Chicken, and Bocadilla Classic Chicken Pasta – potential microbial (Listeria monocytogenes) contamination.

CRUDO and Bocadilla ready to eat meals – Cheekie Pumpkin, Chicken Caesar, Vietnamese Bowl, Jamaican Jerk, Oriental Chicken, and Classic Chicken Pasta – potential microbial (Listeria monocytogenes) contamination.

Cosmetics, Personal Care and TGA Listed Sunscreens:

Transition between NICNAS to AICIS ended 31^st August. The transition period for NICNAS exemptions will not be extended. Source: AICIS.

Search businesses registered with AICIS. New features in business search available from 1^st September. Source: AICIS.

Registration for the 2022 – 2023 year now open There has been no increase in registration fee. If you plan to import or manufacture industrial chemicals – or products that release industrial chemicals – after 31 August, your introductions won’t be authorised unless you register or renew for the 2022-23 year. Source: AICIS

Searching the inventory and assessments. More targeted results for chemical name searches and more inventory features coming October 2022. Preview available. Source: AICIS.

Cancellation of assessment certificate for decabromodiphenylethane. Regulatory action taken due to concerns about the risk to the environment. AICIS.

Variation of Inventory for CAS 754-12-1 listing following evaluation. Variation to the listing is necessary to manage the risks to human health and the environment. AICIS

Correction of chemical names. Relevant to siloxanes and silicones. AICIS.

Have you introduced chemicals that are categorised as exempted? You may need to submit a post-introduction declaration. Once-off declarations only apply after you introduce the certain exempted introductions for the first time. Details available on AICIS.

Annual declarations for chemicals imported in 2021-2022 registration year. Due date for submission is 30^th November. Source: AICIS.

Chemicals added to the Inventory 5 years after issue of assessment certificate. 1 chemical listed on 22^nd July, 9 on the 27^th July, 1 listed on 28^th July, 9 on 30^th August

Callitris columellaris intratropica oil restored to the inventory. AICIS.

Obligations to supply information on 6 chemicals. Approval had been revoked for the proper name of the industrial chemicals to be treated as confidential business information. Source: AICIS.

Evaluations completed at 30th June. 28 evaluations listed on AICIS website here.