Technical Alerts

Pre-registration of products exported to China with the TGA

The TGA has advised CMA that they have sent approximately 1,000 emails to SPONSORS (i.e. the primary contact listed in the ARTG) of approximately 13, 000 listed and export only medicines at 4pm on 20 Oct 2021. The email is to seek registration details (ARTG number, Sponsor name and address, product category and list of all relevant products, HS code, latest date of trade to China) by COB 26 OCT 2021. 

If you have not received the TGA email, please ensure to check your junk or spam folders, otherwise, please contact complementary.medicines@health.gov.au ASAP to request the TGA to send you the email. 

Please direct any enquiries in relation to the pre-registration of products to China with the TGA to complementary.medicines@health.gov.au.

Given that this is a time-sensitive matter, CMA has requested once again that the TGA respond to CMA member emails ASAP, which the TGA has agrees to do.

Pre-registration of products exported to china with the DAWE

The DAWE will be the endorsing authority for any other food products which are not listed in the ARTG (via general trade). The DAWE is seeking registration details from affected establishments by COB 22 Oct 2021 via an online tool. 

Please click here for more information.

CMA has become aware that members have been experiencing issues with BICON and importation of raw materials, samples, or finished products, particularly in the last 12 -24 months. Import requirements are updated regularly and are available on BICON here.

CMA will be meeting with the Animal and Biological Imports Branch within the Department of Agriculture, Environment and Water (DAWE) to discuss how to improve the system for industry users and hopefully put measures in place to prevent costly or time-intensive problems occurring for sponsors and manufacturers.

To seek effective improvements to the system, we need as many examples as possible to understand and resolve the issues and types of problems being encountered. To provide examples and suggested improvements that could be made from your perspective, please email Lucy.Lang@cmaustralia.org.au by 2 November 2021  with the below type of examples and/or information:

Non-identifying information:

-Where you are having trouble finding import conditions in BICON

-How you are searching in BICON, terms entered etc. (this will help us determine what, if any, changes to search terms in BICON may assist)

-Ingredients and level of processing.

-If goods were fully finished/retail ready, or bulk product for further processing/re-packaging in Australia.

-If documentation required by their permit or BICON (if a permit is not required) was provided.

-Challenges with understanding requirements or navigating system.

-Impact it had on your business (time, resources, costs, etc).

Identifying information (not mandatory to provide but preferred if possible to have real-time examples available):

-Entry number(s) for clearance issues where problems have occurred

-Any other specific information relevant to the example such as product name, purpose, company name etc.

CMA provided an informational tech alert on challenges occurring in June 2020 here.

The TGA and the Department of Agriculture, Water and the Environment (DAWE) have released an important update in relation to the new registration process for overseas food manufacturers, responding to Decree 248 & 249 issued by the General Administration of Customs of China (GACC), which will take effect from 1 January 2022.

Today, CMA confirmed with the TGA/DAWE the updates which require urgent attention by all food businesses that export to China. Given the very tight deadlines, CMA strongly recommends members take necessary action by the stipulated deadlines. Please click here for more information.

In recognition of the desire by sponsors and advertisers of therapeutic goods to contribute to the dissemination of the Government's public health messaging about COVID-19 testing, the TGA has issued a permission under section 42DK of the Act, which allows advertisers of certain therapeutic goods included on the ARTG (including listed medicines) to use specific statements that expressly refer to COVID-19 in the context of advising individuals to follow health advice about COVID-19 testing.

The TGA has provided specific wording for the permitted Covid-19 testing statements and has also provided other general cautions about remaining in advertising compliance.

The use of the statements is voluntary and the permission ceases on 31 December 2022.

General statements without reference to COVID-19 may also be used and examples are provided in the new guidance.

Please read today’s technical alert for more information,

The TGA have published new guidance on the Data Protection scheme for assessed listed medicines, which was introduced into the Therapeutic Goods Act 1989 in February 2021. The guidance outlines in detail the operation of the Scheme and requirements and expectations for the sector to utilise the Scheme.

Please read today's full Member Alert for more information and details, including on clinical trial and eligibility requirements of the Scheme. 

The TGA have published new guidance on exporting medicines form Australia. This is a NEW and comprehensive guidance document on exporting medicines form Australia and should be reviewed by all sponsors and persons exporting medicines.

The guidance replaces all previous guidance about the export of medicines from Australia.

The guidance covers topics including:

- Exporting medicines for commercial supply including listings, exemptions, certificates and importing country expectations, TGA assessment criteria, applications, changes, and a wide range of other regulatory matters

 - Exporting medicinal cannabis

- Exporting unapproved goods

- Export certification for medicines - Australia's medicine export certification process, the World Health Organization (WHO) Certification Scheme and Types of export certificates

- Application process and applications that do not meet requirements, applications put on hold

- Non-commercial export - Exporting medicines for donation; Exporting for personal use, family or friends

Please read today’s full technical alert for more information and contact CMA with any concerns about information or processes included in the document. Please also note the TGA are still receiving feedback on this publication in case any changes are required.

The TGA have published information on the their website and the Department of Health Consultation Hub in relation to the consultation on proposed changes to the Therapeutic Good Advertising Code, which occurred from May 2021 to June 2021.

As a result of the feedback received, the TGA have decided to re-write the Code using a ‘simplified structure and plainer language’ and have stated that they will ensure that the guidance on the Code is more accessible and user-friendly. It is anticipated that new Code will be published by the end of 2021.

Please read today’s technical alert for more information

Today's technical alert includes information on the final decision to amend (or not amend) the Poisons Standard in relation to matters referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #27, March 2021). In particular, information in relation to the outcomes on:

 -Hemp Seed Oil; and

 - Processed Aconitum carmichaelii: A scheduling case as it relates to CM/TCM practitioners.

The TGA have provided an extension to the closing date for the Permissible Ingredients Determination low-negligible risk consultation. The consultation closing date is now 29 September 2021. Please note, this updated date is reflected in the Consultation Hub, but will not be reflected on the TGA web page. The date on the Consultation Hub is the correct date. 

The changes proposed in the consultation changes relate to:

 - Peripheral neuropathy associated with lower dose vitamin B6 - a proposed reduction of maximum daily intake from 200mg/day to 50mg/day; and extension of a warning statement for products providing between 10-50mg of equivalent pyridoxine.

- Artemisinin and pregnancy risk - proposed new label requirements for Artemisinin containing products, which may also affect products that have DAVANA OIL in a flavour or fragrance. These changes are proposed as part of the ongoing review of Artemisinin containing medicines and pregnancy risk by the TGA. If you sell DAVAN OIL in any format or in a fragrance or flavour , please contact lucy.lang@cmaustralia.org.au. 

- Allergen Statement for mollusc derived ingredients - proposal for ingredients on the Permissible Ingredients Determination  that are derived from a marine mollusc (substances derived from squid, oyster, green lipped mussel or homeopathic sepia) be updated to include the warning statement :Contains mollusc" or "Contains mollusc products", in alignment with FSANZ Plain English Allergen labelling (PEAL) reforms. it differentiates mollusc as an allergen from crustacea and fish allergens. if this change is made to mollusc ingredients in March 2022 as proposed, this statement would replace the existing requirements to include "Derived from seafood" from that point forward. Sponsors would have until March 2023 to transition existing  listed products to include the new mollusc warning.

Mollusc warning note: CMA provisionally supports the change to the  mollusc warning statement and also consider that this particular change is  likely to be inevitable due to the necessary alignment with FSANZ PEAL  best practice allergen reforms. As there is only a 12 months transition  (March 2022 to March 2023), CMA has sought clarification from the TGA  as to whether products who wish to transition between now and March  2022 (before the Determination is updated) may choose to include both  the statements “Derived from Seafood” as currently required AND  “Contains mollusc” as proposed to be required from March 2022 - the  TGA have responded that they do not hold a compliance concern about  the use of both statements on the label.

This provides an avenue for sponsors who may wish to transition  products early if they are due for their next label run between now and  when a final decision is made and implemented into the 26BB  Determination in March 2022.

Today's technical alert includes:

 - An update on Codex/international discussions on titanium dioxide; and

 - TGA Scheduling Consultation: Proposed amendments to the Poisons Standard - Cannabis and tetrahydrocannabinols for veterinary use.