Very Important Information for All Suppliers of Listed Medicines. Don’t Let Your Product Get Cancelled!

Suppliers of listed complementary medicines will already know that they must now only use indications included in the list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines. The new permitted indications requirements apply to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This includes complementary medicines and sunscreens. (See following story). The key transition dates to note are: 6th September 2019 when the 'fee-free' period for sponsors to transition existing listed products ends. After that date an application fee will apply to all transitioning products in accordance with the TGA's Schedule of fees and charges (currently $820 per product); and 6th March 2021 when any ARTG entries that have not transitioned to Permitted Indications will be automatically cancelled. So please ensure that your product’s indications are compliant before these dates, otherwise you will face significant costs or possible cancellation of your product from the ARTG.   Source: Permitted indications

TGA Details Upcoming Changes to Permissible Indications for Listed Medicines

The Therapeutic Goods Administration has detailed the changes that will be made to the Therapeutic Goods (Permissible Indications) Determination No. 1 of 2018 (the 2018 Determination) in February 2019. Since the implementation of the 2018 Determination in March 2018, stakeholders have raised issues that sponsors have encountered when selecting indications for their listed medicines. A Traditional Chinese Medicine (TCM) expert was also engaged to undertake a further review the TCM indications included in the Determination to confirm that they are appropriate for listed medicines. Based on stakeholder and subject matter expert feedback, the Determination will be amended with the changes outlined in this article. The new Determination will be titled the Therapeutic Goods (Permissible Indications) Determination No. 1 of 2019 (the 2019 Determination).   Source: Permitted indications guidance

TGA Guidance: Releasing Medicines Manufactured at Multiple Sites

The TGA has provided technical guidance on the interpretation of the PIC/S Guide to GMP for sponsors or manufacturers of a medicine manufactured across multiple sites. These guidelines will help relevant manufactrurers understand ‘release for further processing (RFFP)’ requirements, and how RFFP fits into the ‘release for supply (RFS)’ process.   Source: Release for supply

TGA Summarises the First Six Months Since New Advertising Reforms Commenced

There have been many important developments in therapeutic goods advertising regulation over the last six months. This update provides a recap of these changes and outlines what the TGA will focus on next. The Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) came into effect on 1 January 2019.    Source: Advertising reforms

TGA Provides GMP Guidance

Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality. Australian based manufacturers of medicines are required to hold a licence to manufacture. To obtain a licence, a manufacturer must demonstrate compliance with the relevant code of GMP. This is usually, but not always, done through an on-site inspection. Overseas manufacturers of medicines supplied to Australia are also required to meet an acceptable standard of GMP. If acceptable documentary GMP evidence cannot be provided, the TGA will undertake on-site inspections in the same manner as those conducted for the Australian manufacturers. GMP Clearance is a non-statutory mechanism used to verify that overseas manufacturing sites comply with the principles of GMP for the products being supplied to Australia. A GMP clearance can be obtained per manufacturing site via one of three pathways: a Mutual Recognition Agreement (MRA) desktop assessment; a Compliance Verification (CV) desktop assessment; or, an on-site inspection by the TGA. This guidance decribes an eleven-step process to assist sponsors when applying for a new GMP clearance while also covering the steps for maintaining an existing active GMP clearance.   Source: GMP guidance

TGA Reminds Manufacturers that they are Responsible for Maintaining their Active GMP Clearance

Once a manufacturer has successessfully achieved GMP clearance they are then responsible for maintaining the currency and accuracy of that GMP clearance(s) at all times. Maintaining existing GMP clearances by submitting variation applications allows the manufacturer to keep the original GMP clearance number and to avoid the need to update ARTG entries. Only an existing GMP Clearance can be varied. If that clearance is expired by more than 30 days then it will not be able to be varied via the TGA Business Services portal.   Source: Maintaining GMP clearance

TGA Updates the Advertising Complaints and Investigation Information Database

The TGA publishes the outcomes of all advertising complaints, including the actions taken on the complaint. For complaints in the medium risk category or higher, they publish additional information such as the responsible party and the products involved in the complaint. New search options added to the database make it easier to find information about advertising complaints and investigations.    Source: TGA advertising complaints 

CMA Produces Booklet to Harmonise Industry Response to Skewed Media Reports

Complementary Medicines Australia (CMA) is the peak industry body for the complementary medicines industry, representing members across the supply chain, including manufacturers, importers, exporters, raw material suppliers, wholesalers, distributors and retailers. CMA has developed this booklet in response to some biased, inaccurate and misleading media reporting that may ultimately cause undue concern for the Australian public.    Source: CMA media handbook      (Media example: Channel Nine’s 60 Minutes TV show aired on February 10th 2019, with a segment titled ‘Trick Or Treatment’. https://www.9now.com.au/60-minutes/2019/episode-2 . The main thrust of the program was on adverse reactions to products that were not listed on the Australian Register of Therapeutic Goods (ARTG) and hence were illegally supplied products; and other adverse reactions which have not been formally reported using the recognised TGA medicines safety monitoring program.)

Australian Company Pays Fine For Illegal Medicine Exports

On 14 December 2018, the TGA issued Australian company, TK Imports Wholesale Pty Ltd, an infringement notice. It is alleged that TK Imports Wholesale Pty Ltd exported unlawful medicines from Australia. These medicines were not included on the Australian Register of Therapeutic Goods (ARTG) or subject to approvals, exemptions or permits. They were also found to contain undisclosed ingredients. The TGA Regulatory Intelligence and Investigations Section (RIIS) confirmed that the alleged exporter was a repeat offender that had knowledge of the therapeutic goods regulatory scheme through previous dealings with the TGA. TK Imports Wholesale Pty Ltd paid the infringement notice in full on 1 February 2019. The investigation is now closed.   Source: Illegal medicine exports

TGA Safety Advisories—   Source: https://www.tga.gov.au/current-year-alerts

Mang Luk Power Slim capsules ; Boxy Indelar capsules ; ISHOU Fulin Ruan Jiaonang capsules ; BASCHI Quick Slimming capsules ; Deli by New Queen capsules – each of thse products contain the undeclared substance *sibutramine.

*Sibutramine is a prescription-only medicine (which was the active ingredient in Reductil). Sibutramine was withdrawn from the Australian market in October 2010 after a study showed an increased risk of major cardiac events.

Beyond Belief: NZ Supplements Sector Staggered as Government Goes Back to Drawing Board

New Zealand’s natural products sector is facing yet another lengthy process of workshops, surveys and consultations to secure regulations that are fit-for-purpose, after the government signalled its intention to go back to the drawing board.   Source (copyright): Gary Scattergood, Nutraingrdients-Asia NZ regulations

Joint Supplement Arthrem's Makers Being Prosecuted By NZ Health Ministry

The company behind arthritis supplement Arthrem is being prosecuted by the New Zealand Ministry of Health. The directors of Promisia Integrative told the sharemarket recently that the ministry was filing nine charges against the company, alleging that Arthrem was being sold as an unlicensed medicine. The ministry also claims some of Promisia's marketing activities breached the Medicines Act 1981. Promisia's chief executive, Rene de Wit, said it disputed all charges.    Source: Catherine Harris, Stuff Arthrem challenged

ABC-AHP-NCNPR Botanical Adulterants Prevention Program Examines Ashwagandha Roots

The ABC-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program (BAPP) is an international consortium of non-profit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. The BAPP has released its first publication in 2019, a bulletin on adulteration of ashwagandha roots, and root extracts. Despite its long history of use in Ayurvedic medicine, the primary traditional medicine system in India, the popularity of ashwagandha has increased only recently in the United States, now being one of the top 10 best-selling herbs in natural food stores in USA. Unfortunately, there have been reports of adulteration, primarily by replacing ashwagandha root with undeclared ashwagandha leaf material.    Source: ABC on Ashwagandha

 

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