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Technical Alerts

Technical Alerts

This section contains Technical Alerts for members only - to access restricted Technical alerts member login is required.

  • 02 Nov 2021 10:23 AM | Anonymous member (Administrator)

    Following collaboration with the TGA-Industry Working Group on GMP (TIWGG), the TGA have provided an update on certain temporary measures introduced last year for overseas manufacturers. 

    Today's tech alert provides information on the latest update and includes details for sponsors and manufacturers on the following and requests any feedback to CMA through our ongoing participation on TIWGG:

    - Ongoing use of Remote Inspections.

    - Compliance verification pathway.

    - Mutual Recognition Agreement (MRA) pathway.

    - Remote GMP Inspections.

    - GMP clearance

    - Fees and charges associated with inspection and GMP clearance processes.

  • 26 Oct 2021 3:10 PM | Anonymous member (Administrator)

    Today's member alert contains clarifying information for members who are involved in the sale, labelling, or advertising of listed medicines with substances derived from seafood (fish, crustacea or mollusc). These warning statements have been in a state of change to modernise warning statements and changes are still occurring. 

    Today’s alert includes a summary overview of current regulatory status relating to seafood warnings (both current and likely forthcoming due to existing consultations) and recently revised eBS Code Table warnings and listed medicine validation rules for sponsors.

    A selection of sponsors may notice ARTG changes on some listings, affected sponsors will be contacted by the TGA about changes and opportunities to update ARTG records without charge in the near future. Sponsors who are not contacted may also choose to update ARTG records with updated warnings described in this alert as per normal processes (Noting that the ARTG record does not affect legislative requirements, which continue to apply irrespective of the ARTG record).

  • 21 Oct 2021 4:30 PM | Anonymous member (Administrator)

    A new Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2021 will come into effect on 25 October 2021.

    This Technical Alert includes a list of changes for sponsors, manufacturers, raw material suppliers to use to assist in identifying the changes to the Determination. Please note that this alert contains more detailed and specific comparative information about the changes than the summary published on the TGA webpage. This alert details:

    -NEW ingredients and specific requirements that apply to that ingredient

    -CHANGED ingredients with the original requirements and the new or changed requirements.

    -DELETED ingredients if applicable

    For ingredients that have changed:

    -Sponsors should review affected products for changes to compliance requirements (this may include increased or decreased regulatory requirements).

    -Suppliers of raw materials, especially proprietary ingredients, should also ensure that changes to ingredients are checked against materials that they provide to sponsors and manufacturers. Suppliers need to ensure they are providing up-to-date and relevant information to sponsors/manufacturers so that they can remain in compliance with their legal obligations under the Therapeutic Goods Act 1989. The TGA expect sponsors to obtain correct information from suppliers to meet obligations, and for suppliers to provide the necessary and correct information to sponsors (including contacting sponsors if there are changes to requirements that may affect ingredient or product compliance.

  • 21 Oct 2021 4:17 PM | Anonymous member (Administrator)

    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.

  • 21 Oct 2021 4:03 PM | Anonymous member (Administrator)

    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.

  • 20 Oct 2021 4:11 PM | Anonymous member (Administrator)

    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.

  • 05 Oct 2021 3:16 PM | Anonymous member (Administrator)

    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,

  • 29 Sep 2021 3:47 PM | Anonymous member (Administrator)

    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. 

  • 28 Sep 2021 8:47 AM | Anonymous member (Administrator)

    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.

  • 20 Sep 2021 8:45 AM | Anonymous member (Administrator)

    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

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