Australia Health Food Regulations QA

WFOE Registration, Work Permit, Special Industry Permit application according to Sydney Regulations, we need to do KYC (Know your client) before engagement with your assignment.

Email: syd4ww@evershinecpa.com
Australia CA Lily Yan, speak both English and Chinese
2/172-176 Rowe St Eastwood, NSW 2122, Australia

時間：2023/08/24 drafted by Yvonne Chen

HLF-TW-10
What are the categories of health food in Australia? What is its official name? What is the intensity of management of different categories? What is the governmental authority of health food? Website?
Evershine RD：

In Australia, health supplements are known as complementary medicines and are regulated by the Therapeutic Goods Administration (TGA). A product is considered a complementary medicine when its ingredients contain at least one of the specified active ingredients.

Designated Active Ingredients:

1. Amino acid
2. Charcoal
3. Choline salts
4. Essential oils
5. Plant or herbal materials (or synthetic substitutes for such materials)
6. Homeopathic preparations
7. Intact or extracted microorganisms (except vaccines)
8. Minerals
9. Mucopolysaccharides
10. Non-human animal materials (or synthetic substitutes for such materials)
11. Lipids
12. Substances produced or obtained by bees
13. Sugars, polysaccharides, or carbohydrates
14. Vitamins or provitamins

The TGA uses a two-level system to assess the risks of complementary medicines:

1. Drugs with lower risk can be included in the Australian Register of Therapeutic Goods (ARTG).
2. Drugs with higher risk must be registered on ARTG.

【reference link】
https://www.tga.gov.au/overview-regulation-complementary-medicines-australia
https://www.tga.gov.au/news/blog/how-are-vitamins-regulated-australia

HLF-TW-20
If a foreign company wants to sell health food in Australia, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
No business license.

【reference link】
https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines

HLF-TW-25
Evershine RD：
無營業特許證。

HLF-TW-30
If a foreign company wants to sell health food in Australia, can it assign a Australia company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
Yes, supplementary medicines can be sold only after completing product registration, and business agents do not need business registration.

Product Safety

1. The main responsibility is the person in charge of the ARTG of the Therapeutic Goods Register, who is responsible for ensuring the safety and quality of supplementary medicines.
2. When an unsafe incident occurs, the manufacturer is responsible for safety alarms, recalls and other supporting measures.
3. The person in charge of ARTG, distributors, manufacturers, importers, and retailers are all responsible for monitoring the safety of supplementary drugs, and actively report to TGA when adverse events occur.

【reference link】
https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines
https://www.tga.gov.au/resources/resource/guidance/reporting-adverse-events

HLF-TW-35

HLF-TW-40
Do foreign companies need to apply for an approval before importing health food sold to Australia? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：

The Register of Therapeutic Goods (ARTG) is required.

AUST L or AUST R on the Australian Register of Therapeutic Goods (ARTG) listing or registration number. L stands for Listed and R stands for Registered. There are five levels of registration applications for supplementary medicines (RCM 1 to RCM 5). Each level corresponds to an application category. Lower level applications require fewer documents, are less expensive and take less time than higher level applications.

Grade

1. RCM 1
   ．Must be registered with ARTG and undergo a full safety assessment.
   ．Labeling, indications and formulations must be adequately declared.
   ．After application, TGA can review the information on file and ARTG records.
2. RCM 2
   ．Safety, quality and efficacy assessments are based on assessment reports from foreign countries or competent regulatory agencies in foreign jurisdictions.
3. RCM 3
   ．For generic drugs, drugs that do not require bioequivalence data for evaluation, or have been evaluated by COB, and require independent evaluation by TGA for one of the following: safety, quality, efficacy of the drug.
   ．RCM 3 Conditions for Generic Complementary Medicines: Compared to a fully evaluated parent drug, the proposed generic drug must have the same: amount of active ingredient, safety and efficacy profile, and safety and efficacy data provided by the parent drug Shall not be protected, drug form and duly demonstrated therapeutic equivalence.
4. RCM 4, Application for Registration of Complementary Medicine, where one of the following conditions is met:
   ．The application has been evaluated by COB, and TGA needs to complete two of the following evaluations: drug safety, quality, and efficacy.
   ．The application is a generic drug, which requires bioequivalence data to evaluate the drug.
   ．The application is for a registered drug and involves one or more of the following: expansion of drug indications, new direction of drug use, increase in target population of the drug.
5. RCM 5, if not RCM (1 to 4) and one of the following applies:
   ．Requires independent assessment of product safety, quality and efficacy
   ．The application is for a drug that is already registered and is: a new dosage form, a new active, a strong active ingredient, an addition not currently used in complementary medicine.

Time Frame and Cost of Registering for Complementary Drug Assessments

1. RCM 1: 40 working days for initial evaluation notification; 45 days for evaluation.
2. RCM 2: 40 working days for initial evaluation notification; 90 days for evaluation.
3. RCM 3: 40 working days for initial evaluation notification; 150 days for evaluation.
4. RCM 4: 40 working days for initial evaluation notification; 180 days for evaluation.
5. RCM 5: 40 working days for initial evaluation notification; 210 days for evaluation.

Information Required to Register Complementary Medicines

1. General requirements
   ．English: Make sure all materials are in English and readable. For non-English material, please attach a copy in the original language, a full English translation (if assistance is needed, qualified translators can be found through the National Accreditation Institute for Translators, Interpreters (NAATI) website).
   ．Fonts and readability: Make sure tables and images are large enough to be easily read even after copying, scanning, and that any shading does not affect readability. It is suggested that the text should not be smaller than: 12-point font; 10-point font in the form; 10-point font for remarks.
   ．Units of measure: Use metric units. Check that all documents on file refer to measurements in SI units2 or units generally accepted in Australian clinical practice (eg millimeters of mercury, or French manometers).
   ．Responses to Requests (RFIs): If additional information is requested in evaluating your file, please ensure that general file requirements are met (emails up to 40MB are accepted).
   ．Commercial Confidential Information: Whether as part of an application or otherwise, it is commercially confidential.
2. Module information
   ．Module 1: Administrative data and prescribing data.
   ．Module 2: Summary of quality, safety and clinical data.
   ．Module 3: Quality.
   ．Module 4: Non-clinical data (safety).
   ．Module 5: Clinical data (efficacy).

application process

1. TGA commercial service registration and verification
   Register account (Client ID)
   ．Guarantor: The guarantor must be an Australian resident or an Australian body corporate and have a business in Australia, and the company representative lives in Australia.
   ．Address Details: Street, Suburb/State, Zip Code, Postal Address, Business Contact, Billing Details, Email, Phone, Email.
   ．Organization Manager: Administrator’s full name (responsible for establishing and maintaining connections to the organization), email, phone.
   ．Australian representative: At least one Australian representative must be retained. For overseas agents, please designate the Australian representative of your organization as the authorized contact person. Full name, email, and phone number must be kept.
   ．Statement.
   To submit: Email to TGA TBS Help Desk: ebs@health.gov.au
   product registration
   ．Higher risk medicines must be registered on the Australian Register of Therapeutic Goods (ARTG), which involves an individual assessment of the quality, safety and effectiveness of the product.
   ．Low-risk medicines that contain pre-approved low-risk ingredients with limited claims can be listed on (ARTG).
   Product registration information: labeling (including label listing), advertising, reproducibility of SPF test results, stability testing, manufacturing and quality control, allowed ingredients, new ingredients.
2. Check ingredients
   ．Submit ingredient and proprietary ingredient information.
   ．Contains: Australia Approved Name (Chemical Substance), Botanical Name of Herb (Approved Herbal Name), Herbal Ingredient Name.
   ．Submit relevant information to TGA Names via email
3. Ensuring effective GMP
   ．For overseas manufacturers, GMP issued by TGA is required.
   ．If the overseas manufacturer does not have a current GMP license (issued by the TGA), your application cannot be completed. So it is necessary to ensure that the GMP license will not expire within the evaluation period.
4. Determine the application category
   ．Data requirements and assessment timeframes increase with the assessment and risk required for classification, so the correct category is important.
5. Inspection Guidelines
   ．When planning to register an application for a complementary medicine, the relevant technical and regulatory requirements and guidelines need to be identified and understood.
6. Application for exemption
   ．If you meet the exemption conditions, you need to attach the exemption information.
7. Orchestrate data
   ．Arrange the attached files according to the label.
8. Pay fees
9. Complete the registration

Label

1. Product labeling includes labels attached to containers (eg bottles, tubes, sachets, etc.) and primary packaging (eg cartons). Sponsors must ensure that the product label and any printed information accompanying the drug (for example: package leaflet) complies with all relevant regulations (including advertising) before it can be sold in Australia.
2. Graphics, emblems and symbols: Non-corporate graphics, emblems or symbols on the label should be consistent with the product approval details, including the product’s claimed therapeutic use.
3. Advertisements, professional recommendations, endorsements, and sponsorship statements must comply with the Therapeutic Goods Advertising Guidelines.
4. References to other products: References to Sponsor’s other products in the label are permitted provided they are included in (or exempted from) the ARTG.
5. Claims like gluten-free or sugar-free must be true.
6. Only if the information on the website (including any direct links to the website) is consistent with the information contained in the ARTG for the product, may it be indicated on the label.
7. Label statement: As a general guideline, label statements such as new formula or present cannot be used to describe any product, introduction or treatment indication/claim that has been marketed and promoted in Australia for more than 12 years.
8. Excipient ingredients: Excipient ingredients do not need to be declared on the drug label, unless they are restricted ingredients, for example: included in the poison standard. If a sponsor chooses to disclose an (optional) excipient on a drug label, all excipients must be identified.
9. Required labels must be written in English.

【reference link】
https://www.tga.gov.au/sites/default/files/general-dossier-requirements.pdf
https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines
https://www.tga.gov.au/overview-regulation-complementary-medicines-australia

HLF-TW-45

HLF-TW-50
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：

Yes. The Register of Therapeutic Goods (ARTG) is required.

AUST L or AUST R on the Australian Register of Therapeutic Goods (ARTG) listing or registration number. L stands for Listed and R stands for Registered. There are five levels of registration applications for supplementary medicines (RCM 1 to RCM 5). Each level corresponds to an application category. Lower level applications require fewer documents, are less expensive and take less time than higher level applications.

Grade

1. RCM 1
   ．Must be registered with ARTG and undergo a full safety assessment.
   ．Labeling, indications and formulations must be adequately declared.
   ．After application, TGA can review the information on file and ARTG records.
2. RCM 2
   ．Safety, quality and efficacy assessments are based on assessment reports from foreign countries or competent regulatory agencies in foreign jurisdictions.
3. RCM 3
   ．For generic drugs, drugs that do not require bioequivalence data for evaluation, or have been evaluated by COB, and require independent evaluation by TGA for one of the following: safety, quality, efficacy of the drug.
   ．RCM 3 Conditions for Generic Complementary Medicines: Compared to a fully evaluated parent drug, the proposed generic drug must have the same: amount of active ingredient, safety and efficacy profile, and safety and efficacy data provided by the parent drug Shall not be protected, drug form and duly demonstrated therapeutic equivalence.
4. RCM 4, Application for Registration of Complementary Medicine, where one of the following conditions is met:
   ．The application has been evaluated by COB, and TGA needs to complete two of the following evaluations: drug safety, quality, and efficacy.
   ．The application is a generic drug, which requires bioequivalence data to evaluate the drug.
   ．The application is for a registered drug and involves one or more of the following: expansion of drug indications, new direction of drug use, increase in target population of the drug.
5. RCM 5, if not RCM (1 to 4) and one of the following applies:
   ．Requires independent assessment of product safety, quality and efficacy
   ．The application is for a drug that is already registered and is: a new dosage form, a new active, a strong active ingredient, an addition not currently used in complementary medicine.

Time Frame and Cost of Registering for Complementary Drug Assessments

1. RCM 1: 40 working days for initial evaluation notification; 45 days for evaluation.
2. RCM 2: 40 working days for initial evaluation notification; 90 days for evaluation.
3. RCM 3: 40 working days for initial evaluation notification; 150 days for evaluation.
4. RCM 4: 40 working days for initial evaluation notification; 180 days for evaluation.
5. RCM 5: 40 working days for initial evaluation notification; 210 days for evaluation.

Information Required to Register Complementary Medicines

1. General requirements
   ．English: Make sure all materials are in English and readable. For non-English material, please attach a copy in the original language, a full English translation (if assistance is needed, qualified translators can be found through the National Accreditation Institute for Translators, Interpreters (NAATI) website).
   ．Fonts and readability: Make sure tables and images are large enough to be easily read even after copying, scanning, and that any shading does not affect readability. It is suggested that the text should not be smaller than: 12-point font; 10-point font in the form; 10-point font for remarks.
   ．Units of measure: Use metric units. Check that all documents on file refer to measurements in SI units2 or units generally accepted in Australian clinical practice (eg millimeters of mercury, or French manometers).
   ．Responses to Requests (RFIs): If additional information is requested in evaluating your file, please ensure that general file requirements are met (emails up to 40MB are accepted).
   ．Commercial Confidential Information: Whether as part of an application or otherwise, it is commercially confidential.
2. Module information
   ．Module 1: Administrative data and prescribing data.
   ．Module 2: Summary of quality, safety and clinical data.
   ．Module 3: Quality.
   ．Module 4: Non-clinical data (safety).
   ．Module 5: Clinical data (efficacy).

application process

1. TGA commercial service registration and verification
   Register account (Client ID)
   ．Guarantor: The guarantor must be an Australian resident or an Australian body corporate and have a business in Australia, and the company representative lives in Australia.
   ．Address Details: Street, Suburb/State, Zip Code, Postal Address, Business Contact, Billing Details, Email, Phone, Email.
   ．Organization Manager: Administrator’s full name (responsible for establishing and maintaining connections to the organization), email, phone.
   ．Australian representative: At least one Australian representative must be retained. For overseas agents, please designate the Australian representative of your organization as the authorized contact person. Full name, email, and phone number must be kept.
   ．Statement.
   To submit: Email to TGA TBS Help Desk: ebs@health.gov.au
   product registration
   ．Higher risk medicines must be registered on the Australian Register of Therapeutic Goods (ARTG), which involves an individual assessment of the quality, safety and effectiveness of the product.
   ．Low-risk medicines that contain pre-approved low-risk ingredients with limited claims can be listed on (ARTG).
   Product registration information: labeling (including label listing), advertising, reproducibility of SPF test results, stability testing, manufacturing and quality control, allowed ingredients, new ingredients.
2. Check ingredients
   ．Submit ingredient and proprietary ingredient information.
   ．Contains: Australia Approved Name (Chemical Substance), Botanical Name of Herb (Approved Herbal Name), Herbal Ingredient Name.
   ．Submit relevant information to TGA Names via email
3. Ensuring effective GMP
   ．For overseas manufacturers, GMP issued by TGA is required.
   ．If the overseas manufacturer does not have a current GMP license (issued by the TGA), your application cannot be completed. So it is necessary to ensure that the GMP license will not expire within the evaluation period.
4. Determine the application category
   ．Data requirements and assessment timeframes increase with the assessment and risk required for classification, so the correct category is important.
5. Inspection Guidelines
   ．When planning to register an application for a complementary medicine, the relevant technical and regulatory requirements and guidelines need to be identified and understood.
6. Application for exemption
   ．If you meet the exemption conditions, you need to attach the exemption information.
7. Orchestrate data
   ．Arrange the attached files according to the label.
8. Pay fees
9. Complete the registration

Label

1. Product labeling includes labels attached to containers (eg bottles, tubes, sachets, etc.) and primary packaging (eg cartons). Sponsors must ensure that the product label and any printed information accompanying the drug (for example: package leaflet) complies with all relevant regulations (including advertising) before it can be sold in Australia.
2. Graphics, emblems and symbols: Non-corporate graphics, emblems or symbols on the label should be consistent with the product approval details, including the product’s claimed therapeutic use.
3. Advertisements, professional recommendations, endorsements, and sponsorship statements must comply with the Therapeutic Goods Advertising Guidelines.
4. References to other products: References to Sponsor’s other products in the label are permitted provided they are included in (or exempted from) the ARTG.
5. Claims like gluten-free or sugar-free must be true.
6. Only if the information on the website (including any direct links to the website) is consistent with the information contained in the ARTG for the product, may it be indicated on the label.
7. Label statement: As a general guideline, label statements such as new formula or present cannot be used to describe any product, introduction or treatment indication/claim that has been marketed and promoted in Australia for more than 12 years.
8. Excipient ingredients: Excipient ingredients do not need to be declared on the drug label, unless they are restricted ingredients, for example: included in the poison standard. If a sponsor chooses to disclose an (optional) excipient on a drug label, all excipients must be identified.
9. Required labels must be written in English.

【reference link】
https://www.tga.gov.au/sites/default/files/general-dossier-requirements.pdf
https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines
https://www.tga.gov.au/overview-regulation-complementary-medicines-australia

HLF-TW-55

HLF-TW-60
What documents are required when importing approved health food into Australia? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：

The Australian Office of Drug Control (ODC) regulates importers of narcotic and psychotropic substances, precursor substances, and anabolic and androgenic drugs to apply for an import license. If no controlled items are included, there is no need to apply for an import license.

1. URL: https://www.odc.gov.au/importers
2. Application information
   ．Applicant Details (Principal Licensee): Name, Title, Phone Number, Contact Email.
   ．Business information: company/organization name, ABN/ACN, Australian business or company number, primary email address, company identification number, street address, postal address, reason for import or export, purpose for which controlled substances are required.
   ．Shipping Agent or Customs Broker: Name, address, and services of the customs or freight forwarding company.
   ．State/Territory Licenses Held: Display the full name, license number, and expiration date of each such license.
   ．Storage and Security: Provide details of where controlled substances are stored, used or supplied. The security of the premises must be appropriate for the substance and quantity that the applicant will import.
   ．Date of last safety report and date of last safety inspection by state/territory health department officials.
   ．Provide details of the transport security measures for each drug class (S4, S8, S9) and describe who is responsible for transporting the drug.
   ．Authorized Contact: The license holder may designate someone to submit and discuss import and export license applications on its behalf. Licensee shall state the full name and title of each individual who is an authorized contact.
   ．Declaration and Consent
   3.Submit the application
   ．On paper: Office of Drug Control Narcotics Control Section
   ．Email: NCS@health.gov.au

Customs
Import process

1. Licenses and Permits: Importers of narcotic and psychotropic substances, precursor substances, and anabolic and androgenic drugs need to apply for an import license from the Australian Office of Drug Control (ODC). If no controlled items are included, there is no need to apply for an import license.
2. Valuation: All imported goods into Australia require an accurate valuation in order to calculate relevant duties, duties, fees and taxes. The transaction price is based on the actual payment (or payable) price of the imported goods, with certain adjustments. Customs uses the exchange rate on the day the goods are exported (not the day the goods arrive in Australia) when calculating the transaction value.
3. Taxes, duties and charges
4. Labeling and Instructions: Labeling needs to be compliant, in English and easy to read. Items may be seized if they do not meet labeling requirements.
5. Import customs declaration (customs declarations are divided into three types): import customs declaration for items worth more than AUD 1,000, self-assessment clearance (SAC) statement for items arriving by air or sea with a value of less than AUD 1,000, and declarations for items worth more than AUD 1,000 Warehouse declaration form (N20) for goods in storage before customs clearance.
6. Information required for import
   ．Trade contract
   ．Packing List
   ．Commercial invoice
   ．Bill of lading
   ．Certificate of Origin
   ．Component analysis table, etc.

No sale notification.
【reference link】
https://www.odc.gov.au/importers
https://www.abf.gov.au/importing-exporting-and-manufacturing/importing/how-to-import/requirements
https://business.gov.au/products-and-services/importing/importing-and-your-business

HLF-TW-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：

Microbial Detection

1. Classification information: Provide classification information of microorganisms (including genus, species, strain name/code/culture preservation number), culture source and production method. An Approved Biological Name (ABN) should be provided, otherwise a letter pertaining to the nomenclature application must be provided. ． Information required to demonstrate the quality of microorganisms as active ingredients.
   ．Note the mandatory requirements.
   ．List the requested drug.
   ．State whether the microorganism is derived from or contains genetically modified material.
   ．If the substance is derived from a GMO, or a GMO was used in the manufacturing process, please demonstrate that the substance is not present in the final substance.
   2 If the substance is a living genetically modified microorganism, please provide a statement that the organism is not subject to the Gene Technology Regulation.

manufacturing details

1. Description of manufacturing process and process control
   Information on culture establishment, culture and medium, storage conditions, incubation, batch size should be provided using pharmacopoeial or other validated procedures. Applicants are required to provide the source of the microorganism and its history in the strain development process (including genetic engineering steps), and some examples of genetic engineering steps including: insertion or deletion of antibiotic resistance genes, toxigenic and/or pathogenic properties reduction, the use of recombinant proteins expressing pathogenic virulence factors.
2. For non-viable microorganisms, the inactivation method must also be described. As different inactivation methods and processes may affect cell membrane integrity, sponsors should take steps to ensure and demonstrate that cells remain intact and intact after inactivation.
3. Substances derived from or containing genetically modified organisms (GMO) are regulated by the Gene Technology Act and Gene Technology Regulations, which include regulation of import, manufacture, transportation, storage and disposal. The Gene Technology Regulatory Authority should be contacted early in the process of considering importing, manufacturing or supplying GMOs in therapeutic commodities.
4. For listed drug substances, additional manufacturing details should be provided as required for material control, critical steps and intermediate control, manufacturing process development, and manufacturing process validation and/or evaluation.

characterize

1. Genetic differences between strains of a species translate into the coding of different proteins; differences may be functional and have an impact on the safety and quality of the microorganism as an active ingredient. Evaluation of the characteristics of the strain should elucidate its identity, establish appropriate analytical tests, and identify impurities and incidental components.
2. For live microorganisms, characterization should also include detailed information on antimicrobial resistance and susceptibility profiles, and information addressing missing virulence factors, toxigenic and pathogenic properties.

General characteristics

1. Physicochemical properties: Information on physicochemical properties relevant to microbial characterization should be provided. Including: Appearance, Color, State, Texture, Odor, Solubility, Loss on Drying, Sulfate, pH, Micro and Macro Form etc.
2. Antimicrobial resistance and susceptibility:
   ．Therapeutic products containing live microorganisms as active ingredients should not increase the risk of transferring antibiotic resistance to the host. Antibiotics considered should be those relevant to human medicine use in Australia and classified as high, medium or low in importance by the Australian Antimicrobial Resistance Strategic and Technical Advisory Group (ATAG).
   ．Although antifungal drug resistance develops less rapidly than antibiotic resistance, therapeutics containing live microorganisms as active ingredients should not exert selective pressure on fungal resistance in the host.
3. Antibiotic resistance and susceptibility profiles
   ．Provide information to demonstrate antimicrobial resistance and susceptibility of anticipated proposed substances or RCMs containing live microorganisms as active ingredients.
   ．The application requirements for new substances in listed medicines should provide information on the physicochemical properties relevant to the microbiological characterization. Including appearance, color, state, texture, odor, solubility, loss on drying, sulfate, pH, micro and macro morphology, etc.
   ．For live microorganisms, characterization should also include detailed information on antimicrobial resistance and susceptibility profiles, and address missing virulence factors, toxigenic and pathogenic properties.
   ．For RCM, additional manufacturing details should be provided as outlined in the relevant section. Resistance to at least two commercially available antibiotics (e.g. ampicillin, streptomycin, erythromycin, clindamycin, tetracycline, chloramphenicol) as defined by ASTAG should be demonstrated Sensitivity to therapeutic concentrations.
   ．The minimum inhibitory concentration (MIC) should be determined using internationally recognized standard methods.
4. Antimicrobial resistance genes
   ．Where genomic data are available, in silico searches for antimicrobial resistance genes in at least two maintained databases are recommended to obtain a comprehensive understanding of relevant safety aspects of the live microorganisms being assessed. In silico analysis using a database capturing antimicrobial resistance genes from genome-wide datasets can identify any potential genetic resistance. In general, query sequences should be reported for at least 80% (at protein level or nucleotide level) and 70% length of the subject sequence hits.
5. Lack of horizontal drag transferability
   ．The endogenous microbiome in the host serves as a baseline defense against pathogens.
   ．Therefore, the horizontal transfer of genes encoding antimicrobial resistance to the host microbiome is undesirable. The genomes of live microorganisms to be assessed should be free of functional and transferable antimicrobial resistance genetic DNA that could convert to an antimicrobial resistance phenotype. When genomic data are available, searches for mobile or transposable genetic elements are required.
6. Absence of virulence factors
   ．Genes encoding known virulence factors (toxins, cell surface proteins that mediate microbe attachment, cell surface carbohydrates and proteins that protect microbes, hydrolases that may contribute to microbe pathogenicity, invasion and adhesion factors) should be searched for using the following methods Computational comparisons are performed in published databases, using the smallest available threshold for the coverage length in the database.
   ．If virulence factor genes are detected, details of any strain development strategies (including genetic engineering) aimed at reducing the virulence of the strain used should be provided. Where genomic data are available, in silico searches for antimicrobial resistance genes in at least two maintained databases are recommended to obtain a comprehensive picture of the relative safety of the live microorganisms being assessed.

Identity

1. For all microorganisms used as active ingredients, their genus, species and strain name/code/culture preservation number need to be identified.
2. Proteomic and phenotypic approaches: The phenotypic identification of microorganisms relies on morphological, physiological and biochemical properties that can yield different results. If the identity of the microorganisms being assessed is sufficiently established using genomic approaches, proteomic or phenotypic approaches are not required.

Determination

1. For live microorganisms used as substances in listed pharmaceuticals, assay tests provide validated specifications to determine the presence and amount (amount) of the microorganisms being evaluated. Counts or counts of individual microbial strains, expressed as colony forming units (CFU) or number of viable organisms, should be determined by an appropriate microbial enumeration test.
2. For non-viable microorganisms used as substances in listed drugs, express counts or counts of individual microbial strains in terms of the number of inactivated organisms using appropriate microbiological quality control tests. If counting or cell counting is performed prior to the inactivation step, the assay should be expressed as inactivated CFU as determined by an appropriate microbiological enumeration test.
   ．Impurities and Incidental Components: Impurities and Incidental Components are contaminants, components present in the microorganism as a by-product of production, or produced during the processing or storage of the microorganism.

Specification

1. Information such as description, characterization (identification, determination, impurity) analytical methods and acceptance criteria should be provided in the form of composition guidelines using the composition guidance template.
2. Information required to prove security
   ．Systematic literature search
   ．History and Patterns of Human Use
   ．Biological activity
   ．Toxicological data
   ．A list of the nature, severity and frequency of adverse reactions

Good Manufacturing Practice (GMP)

1. The basic principles of GMP are:
   ．Unable to perform quality inspection on a batch of products
   ．At all stages of the manufacturing process, quality must be built into each batch.
2. Overseas manufacturers supplying to Australia must also meet acceptable GMP standards.
3. If acceptable documentary GMP evidence cannot be provided, TGA will conduct on-site inspections in the same way as Australian manufacturers.
4. Any documents that are evidence of a GMP license application must be:
   ．An exact and complete copy of the original document. As an applicant, you are responsible for the authenticity of the documents provided, and heavily edited or changed documents will not be accepted.
   ．In English, or with an English translation by an independent certified translator.
   ．The latest and valid version.
5. Provide information
   ．Inspection reports from recognized regulatory agencies.
   ．Manufacturer’s name and address.
   ．latest certificate.
   ．The GLP certificate of the cooperative laboratory must be accredited by ISO.
   ．The scope of the inspection report covers the scope of application i.e. sterility, dosage form, drug substance, manufacturing steps and buildings covered.
   ．The time required for the inspection and the size of the inspection team are clearly documented in the report.
   ．Regulatory Checklist: A Site Master File (SMF) or equivalent is required as it provides information on the manufacturer’s operations, facilities and quality management system.
   ．List of products to be supplied: It is necessary to ensure that the substance or dosage form is within the scope of the application and provide the AUSSTR/AUSTL number.
   ．Ensure GMP, quality or technical agreements.
   ．Validation Master Plan (VMP).
   ．Other types of evidence: API declarations, etc.

【reference link】
https://www.tga.gov.au/resources/resource/guidance/requirements-microorganism-characterisation-listed-medicines-and-registered-complementary-medicines
https://www.tga.gov.au/good-manufacturing-practice-overview

HLF-TW-75

HLF-TW-77

HLF-TW-80
After a foreign subsidiary imports health food and entrusts a distributor in Australia to sell it, does the distributor need a health food business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：

Dealers do not need a business license.

Product Safety
1.The main responsibility is the person in charge of the ARTG of the Therapeutic Goods Register, who is responsible for ensuring the safety and quality of supplementary medicines.
2.When an unsafe incident occurs, the manufacturer is responsible for safety alarms, recalls and other supporting measures.
3.The person in charge of ARTG, distributors, manufacturers, importers, and retailers are all responsible for monitoring the safety of supplementary drugs, and actively report to TGA when adverse events occur.

【reference link】
https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines
https://www.tga.gov.au/resources/resource/guidance/reporting-adverse-events

HLF-TW-85

Contact Us
E-mail: syd4ww@evershinecpa.com
Australia CA Lily Yan, speak both English and Chinese
2/172-176 Rowe St Eastwood, NSW 2122, Australia
or
For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4syd@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable for your case.
Email address:dalechen@evershinecpa.com
Linkedin address: Dale Chen

Additional Information
Evershine has 100% affiliates in the following cities:
Headquarter, Taipei, Xiamen, Beijing, Shanghai, Shanghai,
Shenzhen, New York, San Francisco, Houston, Phoenix Tokyo,
Seoul, Hanoi, Ho Chi Minh, Bangkok, Singapore, Kuala Lumpur,
Manila, Dubai, New Delhi, Mumbai, Dhaka, Jakarta, Frankfurt,
Paris, London, Amsterdam, Milan, Barcelona, Bucharest,
Melbourne, Sydney, Toronto, Mexico

Other cities with existent clients:
Miami, Atlanta, Oklahoma, Michigan, Seattle, Delaware;
Berlin, Stuttgart; Prague; Czech Republic; Bangalore; Surabaya;
Kaohsiung, Hong Kong, Shenzhen, Donguan, Guangzhou, Qingyuan, Yongkang, Hangzhou, Suzhou, Kunshan, Nanjing, Chongqing, Xuchang, Qingdao, Tianjin.

Evershine Potential Serviceable City (2 months preparatory period):
Evershine CPAs Firm is an IAPA member firm headquartered in London, with 300 member offices worldwide and approximately 10,000 employees.
Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people.
Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)
Please send email to HQ4syd@evershinecpa.com

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