An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections. Information about which version of the Code will apply to advertisements for the purposes of advertising pre-approval and complaints handling is also provided, along with information about the enforcement discretion policy the TGA will apply in 2019 for complaints about advertisements that do not comply with the Code.
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections. Information about which version of the Code will apply to advertisements for the purposes of advertising pre-approval and complaints handling is also provided.
TGA presentation: Advertising therapeutic goods to consumers - Complying with...TGA Australia
An overview of the legislative framework that the TGA administers to regulate the advertising of therapeutic goods, including an exploration of key concepts, such as why advertising is regulated, the definition of ‘advertise’, food-medicine and cosmetic-medicine interface issues, prohibited representations and restricted representations.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Australia has strict regulations for pharmaceuticals and medical devices overseen by the Therapeutic Goods Administration (TGA). Medicines and devices are categorized and must receive manufacturing licenses and marketing approval from the TGA. Clinical trials are regulated through the Clinical Trial Exemption or Notification Schemes. The Pharmaceutical Benefits Scheme subsidizes prescription drugs that meet criteria including medical need and cost-effectiveness. Advertising of medicines is regulated and direct-to-consumer advertising of prescription drugs is prohibited. Patents lasting 20 years can protect pharmaceutical innovations if they are novel, inventive and useful. Trademarks lasting 10 years distinguish goods and services. Product liability draws from common law and federal and state statutes.
The document summarizes the Price Act (R.A. 7581), which aims to stabilize prices of basic necessities and protect consumers from price manipulation. It establishes the following:
1) The National Price Coordinating Council (NPCC) oversees price monitoring and regulation, with representatives from government agencies and private sectors.
2) Local Price Coordinating Councils (LPCCs) coordinate price stabilization programs and make recommendations at the local level.
3) Implementing agencies like DTI, DA, DOH, and DENR monitor prices, investigate irregularities, and establish suggested retail prices or ceilings when needed.
4) Automatic price control and mandated price ceilings can
Registration procedure of drugs in european unionbdvfgbdhg
This document outlines various procedures for registering medicinal products in the European Union. It describes the centralized procedure administered by the European Medicines Agency and national procedures administered by individual member states. It also covers the mutual recognition and decentralized procedures which allow registration in multiple member states based on one member state's assessment. There are also simplified registration procedures for certain herbal medicinal products.
The Therapeutic Goods Administration (TGA) regulates medicines and medical devices in Australia. There are different categories of applications for prescription medicines - Category 1 involves new drugs or changes requiring clinical data review, Category 2 involves identical drugs already approved in other countries, and Category 3 involves quality changes only. Applications are processed within statutory timeframes, and variations to approved drugs can be major requiring full review, or minor involving low-risk changes with streamlined processes. Fees are charged depending on the type and complexity of the application or variation.
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections. Information about which version of the Code will apply to advertisements for the purposes of advertising pre-approval and complaints handling is also provided.
TGA presentation: Advertising therapeutic goods to consumers - Complying with...TGA Australia
An overview of the legislative framework that the TGA administers to regulate the advertising of therapeutic goods, including an exploration of key concepts, such as why advertising is regulated, the definition of ‘advertise’, food-medicine and cosmetic-medicine interface issues, prohibited representations and restricted representations.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Australia has strict regulations for pharmaceuticals and medical devices overseen by the Therapeutic Goods Administration (TGA). Medicines and devices are categorized and must receive manufacturing licenses and marketing approval from the TGA. Clinical trials are regulated through the Clinical Trial Exemption or Notification Schemes. The Pharmaceutical Benefits Scheme subsidizes prescription drugs that meet criteria including medical need and cost-effectiveness. Advertising of medicines is regulated and direct-to-consumer advertising of prescription drugs is prohibited. Patents lasting 20 years can protect pharmaceutical innovations if they are novel, inventive and useful. Trademarks lasting 10 years distinguish goods and services. Product liability draws from common law and federal and state statutes.
The document summarizes the Price Act (R.A. 7581), which aims to stabilize prices of basic necessities and protect consumers from price manipulation. It establishes the following:
1) The National Price Coordinating Council (NPCC) oversees price monitoring and regulation, with representatives from government agencies and private sectors.
2) Local Price Coordinating Councils (LPCCs) coordinate price stabilization programs and make recommendations at the local level.
3) Implementing agencies like DTI, DA, DOH, and DENR monitor prices, investigate irregularities, and establish suggested retail prices or ceilings when needed.
4) Automatic price control and mandated price ceilings can
Registration procedure of drugs in european unionbdvfgbdhg
This document outlines various procedures for registering medicinal products in the European Union. It describes the centralized procedure administered by the European Medicines Agency and national procedures administered by individual member states. It also covers the mutual recognition and decentralized procedures which allow registration in multiple member states based on one member state's assessment. There are also simplified registration procedures for certain herbal medicinal products.
The Therapeutic Goods Administration (TGA) regulates medicines and medical devices in Australia. There are different categories of applications for prescription medicines - Category 1 involves new drugs or changes requiring clinical data review, Category 2 involves identical drugs already approved in other countries, and Category 3 involves quality changes only. Applications are processed within statutory timeframes, and variations to approved drugs can be major requiring full review, or minor involving low-risk changes with streamlined processes. Fees are charged depending on the type and complexity of the application or variation.
Vitafoods eu clinical trials regulationAxon Lawyers
The document discusses the key changes to the legal framework for clinical trials in the EU under the new Clinical Trials Regulation, including streamlined application procedures, a single submission process, increased transparency requirements, and clarification around what products are considered medicinal products versus food or dietary supplements.
DADA Consultancy B.V. is a premier consulting agency based in Nijmegen, Netherlands that has provided regulatory affairs and pharmacovigilance services since 1984. They focus on establishing long-term partnerships with international clients. Their services include full regulatory support and pharmacovigilance activities like safety signal detection, monitoring safety issues, and preparing reports for health authorities. As experts in communicating with health authorities, their goal is to ensure products' safety profiles are properly managed to maintain marketing authorization.
Vitafoods marketing functional food to childrenAxon Lawyers
The document discusses marketing functional foods to children in the EU. It outlines WHO recommendations to reduce marketing of unhealthy foods to children. In the EU, health claims must meet strict criteria and not mislead consumers. National self-regulatory bodies in countries like the Netherlands set rules for food advertising to children, generally prohibiting advertising of foods high in fat, sugar, or salt for children under 12. Effectiveness of self-regulation is debated as some find additional restrictions are still needed.
Vitafoods B2C communication in the funtional food Axon Lawyers
1) The document discusses the legal framework for health, nutrition, and medical claims regarding functional foods and nutraceuticals in B2C communication in the EU.
2) It outlines the differences between nutrition claims, health claims, and medical claims and the conditions for using each type of claim. Nutrition claims relate to nutrient content while health claims relate the relationship between a food and health. Medical claims are not allowed for foods.
3) The document also discusses requirements for food information to consumers regarding ingredients, legibility, and nutrition declarations according to the Food Information to Consumers Regulation.
ANVISA is the regulatory body for health surveillance in Brazil. It was established in 1999 to protect public health by regulating products and services under health surveillance. ANVISA's mission is to protect and promote health by ensuring hygiene, safety of products and services, and facilitating access. The agency is responsible for surveillance of areas like drugs, cosmetics, food, medical devices, and more. It coordinates the National Health Surveillance System and establishes standards. ANVISA's website provides information on regulations, registered products, permits and more.
1) The document discusses the legal framework for classifying life sciences products, such as foods, medicinal products, and medical devices.
2) It analyzes case law that has established criteria for determining if a product is a medicinal product based on its presentation or function.
3) The document provides guidance on how to obtain approval for health claims about products and how to respond if a product's classification is challenged by regulators.
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
Marketing authorization procedures in euRajaniKarpur
There are three main procedures for obtaining marketing authorization in the EU:
1. Centralized Procedure allows applicants to obtain approval in all EU countries by applying to the EMEA and results in a binding Commission decision. It is mandatory for certain product types.
2. Mutual Recognition Procedure involves approval in multiple countries based on recognition of an existing national authorization. Applications are made to both a Reference and Concerned Member States.
3. Decentralized Procedure is similar but applies to products without prior EU authorization. Applications are made simultaneously to a Reference and Concerned Member States.
Very good pmda 介紹上市後監督(英文)-s401 03 tomoko okudaira才雄 呂
1) The document discusses pharmacovigilance practices in Japan, including an overview of the Pharmaceuticals and Medical Devices Agency (PMDA) and its role in post-marketing safety activities.
2) Key post-marketing activities discussed include good vigilance practice (GVP), adverse drug reaction (ADR) reporting, early post-marketing phase vigilance (EPPV), and drug re-examination.
3) Risk management strategies used in Japan are also summarized, such as risk communication tools, managed drug distribution programs, and the Thalidomide risk management system as an example.
This document provides information about ANVISA, the National Health Surveillance Agency of Brazil. Some key points:
- ANVISA is the regulatory body that oversees pharmaceuticals, cosmetics, medical devices and other health products in Brazil. It was established in 1999.
- ANVISA's mission is to protect and promote public health by ensuring safety and quality standards for products and services.
- It is responsible for monitoring drug prices, medical device approval, tobacco control and more. ANVISA works with the Brazilian Ministry of Health.
- Detailed guidelines are provided around the registration of new drugs, generic drugs, medical devices and other regulated products in Brazil according to ANVISA's
Classification:
Emergency situation
Report or confirmed illness
Product tampering which could result in injury.
Adverse finding by a regulatory agency of a hazard
Presence of an undeclared allergen in a product.
Priority situation
Temporary or medically reversible adverse health consequence and where the probability of serious adverse health consequences is remote.
Routine situation
Adulteration or misbranding not involving a health hazard.
This document summarizes the key impacts of China's new Food Safety Law on infant formula, health foods, and special dietary foods. It discusses increased regulations for infant formula, including whole process quality control, product registration, and restrictions on sub-packaging and using the same formula for different brands. It also outlines the import process for infant formula and challenges import companies may face, such as ensuring formulas are registered and formulations comply with local policies.
ANVISA is the Brazilian Health Surveillance Agency established in 1999 to coordinate the National Sanitary Surveillance System and other health programs. It is responsible for regulating drugs, medical devices, food, cosmetics and other products. ANVISA monitors prices, conducts inspections, and provides technical support. It aims to protect public health through sanitary control of production, marketing and borders. ANVISA is part of the decentralized National System of Sanitary Surveillance and works with various federal, state and municipal agencies.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
The Pharmaceutical and Medical Devices Agency (PMDA) regulates pharmaceuticals and medical devices in Japan. It reviews marketing applications, monitors post-market safety, and provides compensation for adverse drug reactions. The PMDA was established in 2004 by consolidating various regulatory bodies and works closely with the Ministry of Health, Labour and Welfare (MHLW), which handles clinical studies, approvals, and licensing. Both agencies aim to protect public health by ensuring safety, efficacy, and quality.
The document discusses various government agencies and bureaus responsible for consumer protection, product standards, and environmental regulation in the Philippines. It outlines the objectives of the Consumer Act of the Philippines to protect consumer interests. It also describes the roles of the National Water and Air Pollution Control Commission, Bureau of Trade Regulation and Consumer Protection, Bureau of Food and Drugs, Bureau of Domestic Trade, and Bureau of Product Standards in maintaining standards, conducting inspections, and ensuring consumer and environmental protections.
This document outlines the requirements for obtaining and renewing a license to operate (LTO) for a drug establishment. It lists 11 documents required for an initial inspection, including documents proving ownership or lease of the establishment, permits, pharmacist qualifications, and standard operating procedures. An additional 13 documents are required for importers, wholesalers, or exporters. Reference materials and standard operating procedures must be presented at inspection. Reissuance of an LTO requires surrender of the original LTO, a picture of the establishment, and proof of renewal fees.
Building on Drug Safety - the new EU guidelines May 2012Doctors.net.uk
This document discusses new EU regulations that are changing how drug safety is monitored. Key changes include centralized adverse drug reaction reporting, required risk management plans for new drugs, and a new risk assessment committee. The regulations aim to take a more proactive, proportional, and transparent approach to pharmacovigilance to better protect public health. National authorities and the EMA will provide information on company drug safety systems, adverse events, risk minimization plans, and committee decisions.
Pharmaceutical Regulations in GCC countriesIman Ajami
The Gulf Cooperation Council (GCC) regulatory authorities approved a centralized drug registration system located in Riyadh, Saudi Arabia in 1999. The system aims to improve patient access to safe and effective medicines across GCC countries. The GCC Central Drug Registration Committee is composed of two members from each GCC state. Applications are reviewed by two selected states alphabetically, but all states are responsible for evaluating quality, safety and efficacy. States meet regularly to discuss applications and make approval decisions by agreement. Registration requirements and procedures are generally harmonized across GCC states but some variation remains. Further harmonization efforts are still needed.
Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
The document provides an overview of the Therapeutic Goods Advertising Code (No. 2) 2018. It discusses the background and legislative framework for advertising therapeutic goods in Australia, including the Therapeutic Goods Act 1989 and Competition and Consumer Act. Key points covered include definitions of terms in the Code like 'health warning' and what constitutes advertising. It also summarizes the differences between the 2015 and 2018 versions of the Code, such as updated mandatory information requirements and changes to prohibited representations. Overall, the document aims to outline and explain the purpose and requirements of the Therapeutic Goods Advertising Code.
Vitafoods eu clinical trials regulationAxon Lawyers
The document discusses the key changes to the legal framework for clinical trials in the EU under the new Clinical Trials Regulation, including streamlined application procedures, a single submission process, increased transparency requirements, and clarification around what products are considered medicinal products versus food or dietary supplements.
DADA Consultancy B.V. is a premier consulting agency based in Nijmegen, Netherlands that has provided regulatory affairs and pharmacovigilance services since 1984. They focus on establishing long-term partnerships with international clients. Their services include full regulatory support and pharmacovigilance activities like safety signal detection, monitoring safety issues, and preparing reports for health authorities. As experts in communicating with health authorities, their goal is to ensure products' safety profiles are properly managed to maintain marketing authorization.
Vitafoods marketing functional food to childrenAxon Lawyers
The document discusses marketing functional foods to children in the EU. It outlines WHO recommendations to reduce marketing of unhealthy foods to children. In the EU, health claims must meet strict criteria and not mislead consumers. National self-regulatory bodies in countries like the Netherlands set rules for food advertising to children, generally prohibiting advertising of foods high in fat, sugar, or salt for children under 12. Effectiveness of self-regulation is debated as some find additional restrictions are still needed.
Vitafoods B2C communication in the funtional food Axon Lawyers
1) The document discusses the legal framework for health, nutrition, and medical claims regarding functional foods and nutraceuticals in B2C communication in the EU.
2) It outlines the differences between nutrition claims, health claims, and medical claims and the conditions for using each type of claim. Nutrition claims relate to nutrient content while health claims relate the relationship between a food and health. Medical claims are not allowed for foods.
3) The document also discusses requirements for food information to consumers regarding ingredients, legibility, and nutrition declarations according to the Food Information to Consumers Regulation.
ANVISA is the regulatory body for health surveillance in Brazil. It was established in 1999 to protect public health by regulating products and services under health surveillance. ANVISA's mission is to protect and promote health by ensuring hygiene, safety of products and services, and facilitating access. The agency is responsible for surveillance of areas like drugs, cosmetics, food, medical devices, and more. It coordinates the National Health Surveillance System and establishes standards. ANVISA's website provides information on regulations, registered products, permits and more.
1) The document discusses the legal framework for classifying life sciences products, such as foods, medicinal products, and medical devices.
2) It analyzes case law that has established criteria for determining if a product is a medicinal product based on its presentation or function.
3) The document provides guidance on how to obtain approval for health claims about products and how to respond if a product's classification is challenged by regulators.
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
Marketing authorization procedures in euRajaniKarpur
There are three main procedures for obtaining marketing authorization in the EU:
1. Centralized Procedure allows applicants to obtain approval in all EU countries by applying to the EMEA and results in a binding Commission decision. It is mandatory for certain product types.
2. Mutual Recognition Procedure involves approval in multiple countries based on recognition of an existing national authorization. Applications are made to both a Reference and Concerned Member States.
3. Decentralized Procedure is similar but applies to products without prior EU authorization. Applications are made simultaneously to a Reference and Concerned Member States.
Very good pmda 介紹上市後監督(英文)-s401 03 tomoko okudaira才雄 呂
1) The document discusses pharmacovigilance practices in Japan, including an overview of the Pharmaceuticals and Medical Devices Agency (PMDA) and its role in post-marketing safety activities.
2) Key post-marketing activities discussed include good vigilance practice (GVP), adverse drug reaction (ADR) reporting, early post-marketing phase vigilance (EPPV), and drug re-examination.
3) Risk management strategies used in Japan are also summarized, such as risk communication tools, managed drug distribution programs, and the Thalidomide risk management system as an example.
This document provides information about ANVISA, the National Health Surveillance Agency of Brazil. Some key points:
- ANVISA is the regulatory body that oversees pharmaceuticals, cosmetics, medical devices and other health products in Brazil. It was established in 1999.
- ANVISA's mission is to protect and promote public health by ensuring safety and quality standards for products and services.
- It is responsible for monitoring drug prices, medical device approval, tobacco control and more. ANVISA works with the Brazilian Ministry of Health.
- Detailed guidelines are provided around the registration of new drugs, generic drugs, medical devices and other regulated products in Brazil according to ANVISA's
Classification:
Emergency situation
Report or confirmed illness
Product tampering which could result in injury.
Adverse finding by a regulatory agency of a hazard
Presence of an undeclared allergen in a product.
Priority situation
Temporary or medically reversible adverse health consequence and where the probability of serious adverse health consequences is remote.
Routine situation
Adulteration or misbranding not involving a health hazard.
This document summarizes the key impacts of China's new Food Safety Law on infant formula, health foods, and special dietary foods. It discusses increased regulations for infant formula, including whole process quality control, product registration, and restrictions on sub-packaging and using the same formula for different brands. It also outlines the import process for infant formula and challenges import companies may face, such as ensuring formulas are registered and formulations comply with local policies.
ANVISA is the Brazilian Health Surveillance Agency established in 1999 to coordinate the National Sanitary Surveillance System and other health programs. It is responsible for regulating drugs, medical devices, food, cosmetics and other products. ANVISA monitors prices, conducts inspections, and provides technical support. It aims to protect public health through sanitary control of production, marketing and borders. ANVISA is part of the decentralized National System of Sanitary Surveillance and works with various federal, state and municipal agencies.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
The Pharmaceutical and Medical Devices Agency (PMDA) regulates pharmaceuticals and medical devices in Japan. It reviews marketing applications, monitors post-market safety, and provides compensation for adverse drug reactions. The PMDA was established in 2004 by consolidating various regulatory bodies and works closely with the Ministry of Health, Labour and Welfare (MHLW), which handles clinical studies, approvals, and licensing. Both agencies aim to protect public health by ensuring safety, efficacy, and quality.
The document discusses various government agencies and bureaus responsible for consumer protection, product standards, and environmental regulation in the Philippines. It outlines the objectives of the Consumer Act of the Philippines to protect consumer interests. It also describes the roles of the National Water and Air Pollution Control Commission, Bureau of Trade Regulation and Consumer Protection, Bureau of Food and Drugs, Bureau of Domestic Trade, and Bureau of Product Standards in maintaining standards, conducting inspections, and ensuring consumer and environmental protections.
This document outlines the requirements for obtaining and renewing a license to operate (LTO) for a drug establishment. It lists 11 documents required for an initial inspection, including documents proving ownership or lease of the establishment, permits, pharmacist qualifications, and standard operating procedures. An additional 13 documents are required for importers, wholesalers, or exporters. Reference materials and standard operating procedures must be presented at inspection. Reissuance of an LTO requires surrender of the original LTO, a picture of the establishment, and proof of renewal fees.
Building on Drug Safety - the new EU guidelines May 2012Doctors.net.uk
This document discusses new EU regulations that are changing how drug safety is monitored. Key changes include centralized adverse drug reaction reporting, required risk management plans for new drugs, and a new risk assessment committee. The regulations aim to take a more proactive, proportional, and transparent approach to pharmacovigilance to better protect public health. National authorities and the EMA will provide information on company drug safety systems, adverse events, risk minimization plans, and committee decisions.
Pharmaceutical Regulations in GCC countriesIman Ajami
The Gulf Cooperation Council (GCC) regulatory authorities approved a centralized drug registration system located in Riyadh, Saudi Arabia in 1999. The system aims to improve patient access to safe and effective medicines across GCC countries. The GCC Central Drug Registration Committee is composed of two members from each GCC state. Applications are reviewed by two selected states alphabetically, but all states are responsible for evaluating quality, safety and efficacy. States meet regularly to discuss applications and make approval decisions by agreement. Registration requirements and procedures are generally harmonized across GCC states but some variation remains. Further harmonization efforts are still needed.
Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
The document provides an overview of the Therapeutic Goods Advertising Code (No. 2) 2018. It discusses the background and legislative framework for advertising therapeutic goods in Australia, including the Therapeutic Goods Act 1989 and Competition and Consumer Act. Key points covered include definitions of terms in the Code like 'health warning' and what constitutes advertising. It also summarizes the differences between the 2015 and 2018 versions of the Code, such as updated mandatory information requirements and changes to prohibited representations. Overall, the document aims to outline and explain the purpose and requirements of the Therapeutic Goods Advertising Code.
TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
The document provides background information on Australia's Therapeutic Goods Advertising legislation and Code. It discusses key aspects of the legislation including:
- The Therapeutic Goods Act and Regulations set advertising requirements for therapeutic goods. Advertising must also comply with the Australian Consumer Law.
- The Act prohibits off-label promotion and requires pre-approval of medicine ads in certain media. It also places restrictions on advertising certain medical conditions.
- The Therapeutic Goods Advertising Code provides the framework for ensuring advertising is conducted properly and does not mislead consumers. It was recently revised to provide more clarity.
- The Code applies broadly to any advertising of therapeutic goods. It exempts genuine news reporting and ads directed to health
TGA presentation: What pharmacies need to know about advertising therapeutic ...TGA Australia
An overview of the legislative landscape for pharmacies wanting to advertise therapeutic goods in 2019. Includes a brief overview of the advertising legislation, followed by a summary of the TGA's new advertising complaints handling framework, tips for pharmacies to ensure compliant advertising and how to find more information.
Devices Sponsor Information Day: 5 - Post-market - Advertising therapeutic go...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Update on the therapeutic goods advertising reforms - webinarTGA Australia
This document summarizes updates to Australia's therapeutic goods advertising reforms which aim to improve consumer safeguards around medicine and medical device advertising. Key changes include a new Therapeutic Goods Advertising Code, single complaints handling process, enhanced penalties, and education resources. Advertisers will have a transition period until mid-2020 to comply with the new rules which are designed to increase clarity, support enforcement, and prioritize complaints by public health risk. The reforms establish new criminal offenses, civil penalties, and processes for addressing non-compliant advertising.
TGA Presentation: Medicines scheduling and scheduling policy ad hoc working g...TGA Australia
TGA Scheduling Working Group Meeting One February 2018. Role of the Working Group including Reforms to the advertising of S3 pharmacist only medicines, Reviewing what current S3 substances should be advertised, Proactively identifying S4 medicine substances for consideration for down-scheduling, Adding a new appendix to the poison standard to provide additional safeguards when down-scheduling
Presentation for webinar: The new advertising code - where are we at? 12 jun...TGA Australia
The document summarizes the status of revisions to Australia's Advertising Code for therapeutic goods. It outlines that the code is being updated following consultation to improve clarity and support for sanctions. A proposed 2018 code is expected in July 2018 but would not take effect until January 2019 to allow time to adjust. The summary also notes some differences between the draft code stakeholders saw for consultation and the expected 2018 version, including additional requirements for comparisons ads and direct marketing.
Presentation: Advertising cosmetic injectables - Complying with the therapeut...TGA Australia
The TGA regulates therapeutic goods in Australia, including cosmetic injectables. Advertisements for cosmetic services using Schedule 4 substances like botulinum toxin and hyaluronic acid are prohibited from mentioning the trade names, ingredients, or abbreviations of these substances. To comply, advertisements cannot specify products by name, ingredients, or acronyms and the TGA provides educational resources to help advertisers. Non-compliance may result in penalties and the TGA seeks initially to educate advertisers before regulatory action.
This document provides an overview of changes to regulations around advertising of non-prescription medicines and complementary medicines in Australia. Key changes include: increased clarity and objectivity in the new Therapeutic Goods Advertising Code; new mandatory statements and health warnings; ending of mandatory pre-approvals by 2020 and replacing it with an advisory service; and heavier sanctions and penalties for non-compliance. Marketers have raised concerns around requirements for social media, testimonials, and implied claims. Tips are provided to help marketers avoid common breaches, such as thoroughly understanding products and indications and the new code requirements.
Digital Therapeutics Regulatory Process, Update and TrendsInsights10
The market for digital therapeutics (DTx) is expanding tremendously, aided by the increased popularity of decentralized medicine that the pandemic brought about. The global market for DTx was predicted to be worth $3.35 billion in 2021 and would grow to $12.1 billion by 2026. To get a report in detail, contact us at - info@insights10.com
The UK Code of Non-Broadcast Advertising, Sales Promotion and Direct Marketing (the Code) governs non-broadcast marketing communications in the UK. The Code applies to various forms of advertising and marketing including print, online, sales promotions and direct marketing. The central principle is that marketing must be legal, honest, decent and truthful. The Code covers issues like harm and offense, privacy, environmental claims, children, gambling and more. It aims to ensure marketing is socially responsible and does not exploit or harm consumers.
Presentation: Advertising therapeutic goods to consumers TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections.
CMS recently announced a proposed rule for Medicaid (CMS-2482-P) that builds on current policies to help ensure that opioid prescribing is appropriate, medically necessary, and avoids adverse medical events.
Presentation: Advertising Therapeutic Goods to ConsumersTGA Australia
The document discusses Australia's system for handling complaints about the advertising of therapeutic goods. It provides an overview of the previous complaints handling model and outlines the key features of the new single-body model, including its risk-based approach. Under the new system, complaints are categorized based on risk level and may result in voluntary compliance actions, regulatory actions, or criminal penalties through the courts.
This document provides an overview of Volume 9A which contains guidelines for pharmacovigilance of medicinal products for human use in the EU. It defines pharmacovigilance and describes the roles and responsibilities of marketing authorization holders, competent authorities, and the EMA. Key aspects covered include pharmacovigilance systems, signal detection, safety reporting, risk management plans, and safety communication.
Digital Therapeutics regulations in US, EU and JapanGargiVaghela
This PowerPoint presentation provides a comprehensive overview of the current regulatory landscape governing digital therapeutics in the United States, European Union, and Japan, offering valuable insights on the regulatory perspective of DTx.
Similar to TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code basics (20)
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
The challenges of regulating direct to consumer digital medical devicesTGA Australia
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
Updates from the Pharmacovigilance and Special Access Branch TGA Australia
Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS)
Q and A
Regulatory updates from the Complementary and OTC Medicines Branch - Listed m...TGA Australia
The document discusses several regulatory reforms for listed medicines in Australia, including:
1. Permitted indications which provide a list of approved health benefit claims for listed medicines and require sponsors to select from this list, improving transparency.
2. An assessed listed pathway which allows pre-market evaluation of efficacy claims, providing access to higher-level health claims.
3. A "TGA assessed" label claim indicating the medicine's efficacy has been evaluated, improving consumer awareness and confidence.
4. Two years of market exclusivity for sponsors who apply for and are approved for new permitted ingredients.
Regulation, ethics and reimbursement of novel biological therapies in Austral...TGA Australia
The document provides an overview of novel biological therapies such as gene therapy, cell therapy, and tissue engineering in Australia. It discusses the regulatory pathways through the Therapeutic Goods Administration (TGA) for approval of these therapies. Clinical trials of novel biological therapies must be submitted through the CTX scheme for approval rather than just notification. Guidelines from the European Medicines Agency are a good resource for requirements for registration and approval of these therapies in Australia. Risks associated with gene therapy include potential for delayed adverse effects, off-target effects, insertional mutagenesis, and immune responses.
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Regulatory updates from the TGA Medical Devices Branch - Part 1TGA Australia
Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring
Regulatory updates from the TGA Medical Devices Branch - Part 2TGA Australia
The document summarizes proposed regulatory reforms from the Therapeutic Goods Administration (TGA) Medical Devices Branch. It discusses proposed changes to the regulation of software as medical devices, personalized medical devices including 3D printed devices, essential principles, conformity assessment procedures, requirements for devices used in clinical trials, and clarifying requirements for systems and procedure packs. The proposed reforms aim to modernize regulations, increase alignment with international standards, and ensure oversight is risk-based and promotes safety. Public consultations will be held on the proposed changes.
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Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
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The document provides an overview of Australia's Good Manufacturing Practice (GMP) Clearance Framework. It discusses the legislative basis for manufacturing requirements, the roles and activities of the Manufacturing Quality Branch, and the two pathways for obtaining a GMP Clearance - a desk-based assessment through a Mutual Recognition Agreement or Compliance Verification, or an on-site TGA inspection. It also outlines the history of GMP Clearance, recognized authorities through agreements like MRAs, and the MRA assessment pathway.
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Webinar presentation: Consultation on reforms to the generic medicine market ...TGA Australia
The TGA is consulting on reforms to streamline the generic medicine market authorisation process. The proposed reforms include: 1) Reducing regulatory barriers such as relaxing requirements for dissolution data and reference products in bioequivalence studies. 2) Providing more certainty on data requirements through early advice on biowaiver justifications. 3) Supporting international work sharing by using common templates for bioequivalence studies and biowaiver justifications. 4) Prioritizing applications for generic medicines that address shortages or high expenditure to encourage more competition. Feedback is sought through an online consultation closing March 21. The reforms aim to enhance supply of affordable generic medicines in Australia.
Breast cancer: Post menopausal endocrine therapyDr. Sumit KUMAR
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
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Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
Combination Therapies
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Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
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Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
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1. Therapeutic Goods
Advertising Code (No. 2) 2018
The Code basics
Advertising Education and Assurance Section
Regulatory Education and Compliance Branch
Regulatory Practice and Support Division
13,15 & 20 November 2018
2. Purpose of today
• To educate stakeholders about the Therapeutic Goods
Advertising Code (No.2) 2018 (the 2018 Code)
• To promote an understanding of the requirements of the 2018
Code and their application
• To facilitate a respectful and constructive dialogue about the
application of the Code for the benefit of all participants
• Slides will be published on the TGA website soon
4. Role of the Advertising Code
• The Code is the cornerstone of the advertising framework
– Requires that advertising supports appropriate use of
therapeutic goods and does not mislead or deceive
• Current version is 2015 Code – until 31 December 2018
• The Code was revised to provide clarity and more
objective tests to support sanctions and penalties
3
5. Compliance with Advertising Code
• Advertising to the public for therapeutic goods MUST
comply with the Advertising Code
• Requirement to comply with the Code is specified through
a criminal offence and civil penalty provision in the Act:
– Section 42DM – criminal offence
– Section 42DMA – civil penalty
• For an ad to be approved under the Regulations, the
delegate must be satisfied that it complies with the Code 4
6. About the 2018 Code
• The 2018 Code was made on 31 October 2018, to take
effect on 1 January 2019
• Principles underpinning 2015 and 2018 Codes are similar
• The 2018 Code is supported by specific guidance
5
7. Code version for pre-approvals
• Ads for medicines to appear in specified media require pre-
approval under Regulation 5G
• For pre-approval decisions made:
– On or after 1 January 2019: 2018 Code applied
– On or before 31 December 2018: 2015 Code applied
• You must allow time for the process, any revisions and
Christmas shut downs
6
8. Code version applied in compliance
• For ads with current approval: version of Code approved
under
• For ads (other than pre-approved ads) that occurred:
Advertising occurred 2018 Code
On or after 1 January 2019 2018 Code
Before 1 January 2019 and is
no longer occurring
2015 Code
Before 1 January 2019 and is
still occurring
2018 Code
7
9. Compliance approach
• Details of the TGA’s advertising complaints handling
framework has been published:
https://www.tga.gov.au/publication/complaints-handling-
advertising-therapeutic-goods-australian-public
• TGA statement on its approach to compliance and
enforcement discretion in the changeover to 2018 Code:
https://www.tga.gov.au/therapeutic-goods-advertising-
update-29-october-2018
8
10. Scheduling of medicines
• No advertising to
consumers
• S3 – only Appendix H can
be advertised
• Can be advertised to
consumers
• S8 - Drugs of Dependence – by
prescription
• S4 - By prescription only
• S3 - Pharmacist only – behind the
counter
• S2 - Pharmacy only
• Unscheduled – General sales item
9
12. The 2015 & 2018 Codes: key differences
• Principles underpinning the Codes are similar, with the 2018 Code
providing clarification of requirements
• 2018 Code has specific requirements to:
– Identify traditional evidence and paradigm where used as basis
for advertising
– Include specific messages for sunscreens to reinforce public
health messages
– Ensure advertising is not inconsistent with current public health
campaigns
11
13. The 2015 & 2018 Codes: mandatory info
• The 2018 Code includes:
– Updated mandatory statement for S3 medicine ads
– Options for ‘symptom’ mandatories
– Different wording options for other mandatory statements,
including different wording to reflect the type of good
– Clearer definition of ‘prominently displayed or communicated’
– Clearer requirements for what information must be included in
advertising
12
14. The 2015 & 2018 Codes: key differences
• Clarifications of testimonials, endorsements, scientific
representation and samples requirements
• Change to restricted representations definition
– Updated criteria for restricted representations improved
definition of serious as it applies to conditions
– Allowance for conditions that are suitable for self
management following diagnosis
13
15. The 2015 & 2018 Codes: key differences
• Change to prohibited representation definition
– Now incorporates treatment, cure, prevention, diagnosis
(including screening), monitoring or susceptibility of, or
pre-disposition to, the listed diseases
– Skin cancer prevention and preventing transmission of
STDs and HIV are prohibited representations
• Incorporation of the Price Information Code of Practice for
providing prescription medicine prices to consumers
14
17. Structure of the 2018 Code
• Part 1 – Preliminary – definitions, object, application
• Part 2 – General requirements for advertising therapeutic goods
• Part 3 – Specific rules relating to particular therapeutic goods
• Part 4 – Prohibited & restricted representations
• Schedule 1 – Medicines with specific health warnings
• Schedule 2 – Advertising to children
• Schedule 3 – Samples
• Schedule 4 – Price information
• Schedule 5 – Repeals 16
19. Section 4 - Definitions
• It is important to read the Code in conjunction with the Act
and the Therapeutic Goods Regulations 1990
– Terms that are not defined in the Code may be defined
in the Act and Regulations (e.g. ‘advertise’)
• Most Code definitions straightforward but there are some
that we will explore in detail:
– Health warning
– Prominently displayed or communicated 18
20. What are health warnings?
• In some cases, health warnings need to be included in ads
• Concept of ‘health warning’ is defined in s.4 of the Code
• The purpose of health warnings is to alert consumers to
information that will be critical to the consumer's
assessment of whether the advertised product is right for
them before purchase
19
21. Health warning definition - medicines
• Health warnings for medicines are prescribed in Schedule 1 of
the Code
• Schedule 1 health warnings are:
– an exhaustive list but may be updated from time to time
– based on RASML, permitted ingredients determination,
TGO69 and TGO92
– divided into different parts for warnings for registered
medicines, listed medicines and both types of medicines
20
22. Example of medicine health warnings
1. Ingredients 2. Circumstances 3. Health warning
Hydroxyanthracene derivatives such as
those from:
• Aloe
• Buckthorn
• Cascara
• Frangula
• Rhubarb
• Senna
In preparations for oral use where the
MRDD contains MORE than 10mg
Do not use if you have abdominal pain,
nausea, vomiting or diarrhoea
Ibuprofen/Paracetamol combinations In preparations for oral use Do not use if you have a stomach ulcer,
impaired kidney function, heart failure,
allergic to anti inflammatory medicines,
pregnant or trying to become pregnant
21
23. Health warning definition – devices/OTGs
…a statement that is required under the Act or Regulations or Medical Devices
Regulations to be included on the label or in instructions for use that warns that a
person who takes or uses the device or goods as intended may:
(i) die; or
(ii) require hospitalisation or a longer period of hospitalisation than would be
required if the person had not taken or used the device or goods; or
(iii) require a medical practitioner to treat or prevent injury, disability, incapacity or
impairment of any bodily function, organ or structure as a consequence of taking
or using the device or goods
22
24. Prominently displayed or communicated
‘prominently displayed or communicated’ is defined as:
(a) either:
(i) for a visual statement—standing out so as to be easily read from a
reasonable viewing distance for the particular media type in the context in
which the advertisement is intended to be viewed; or
(ii) for a spoken statement—able to be clearly heard and understood; and
(b) repeated as often as is necessary to ensure that it is likely to be
noticeable for a viewer or listener.
23
25. Section 5 – Object of the Code
“...to ensure that the advertising of therapeutic goods to consumers is conducted
in a manner that:
(a) promotes the safe and proper use of therapeutic goods by minimising their
misuse, overuse or underuse; and
(b) is ethical and does not mislead or deceive the consumer or create unrealistic
expectations about product performance; and
(c) supports informed health care choices; and
(d) is not inconsistent with current public health campaigns.“
24
26. Section 6 - Application
• Applies to:
– The advertising of therapeutic goods (ss.6(1))
– By any person advertising or causing advertising (ss.6(5))
• Does not apply to:
– Genuine news (ss.6(6)) by certain bodies (ss.6(7)) – including
broadcasters, datacasters and publishers
– Advertising directed exclusively to health professionals (ss.6(2))
25
27. Section 6 – Application
• How to apply the Code to a particular advertisement:
– consider its likely impact on a reasonable person to
whom the advertisement is directed (ss.6(3))
– the total presentation and context of the advertisement
is to be taken into account (ss.6(4))
26
28. Audience advertisement directed to
• Advertising may be directed to the public in general or a sub-population
• A direction may be made in many forms, including:
– An overt statement e.g. “Do you suffer from cold sores?”, “For the relief of
psoriasis”
– An implied call to capture the attention of a sub-population e.g. for the
measurement of blood pressure
– The location of the ad e.g. in a magazine for diabetics
27
29. Total presentation & context
• Total presentation: the advertisement as a whole
• Context includes:
– What other information is provided around the advertisement that could
change the take-out message? e.g. an editorial on a page opposite the
advertisement
– Does the environment in which it is displayed have the potential to alter the
take-out message? E.g. a billboard ad that is viewed when passing in a car
at speed
28
32. Section 6A & 6B – Repeals & transition
• Section 6A, by reference to Schedule 5, repeals the 2015
Code and the original 2018 Code
• Section 6B allows for a transition period for ads pre-
approved under the 2015 Code – i.e.
– Complaints about such ads will be assessed against the
2015 Code for the life of the approval
31
33. Section 7 - Price information
• Price information – definition in s.4 of Code – relates to
prescription medicines and pharmacist-only medicines only
• S.42DL(10) of the Act – advertising of prescription medicines to
the public prohibited “other than a reference authorised or
required by a government or government authority”
• Section 7 of the Code authorises the dissemination of price lists
that comply with Schedule 4 of the Code – i.e. not an offence
under the Act
• Schedule 4 replaces Price information code of practice 32
34. Part 2 - Requirements for
advertising all therapeutic
goods to the public
33
35. Section 8 – Approved ads
• Ads for medicines for ‘specified media’ (e.g. free-to-air
television, newspaper, billboard) require prior approval
under Regulation 5G
Arises from offence under section 42C of Act
• S.8 requires ads appearing in print media and billboards to
display the approval number in the advertisement as set
out in ss.8(3) – must be legible
34
36. S.9 – Accuracy: validity & substantiation
Advertising for therapeutic goods must satisfy the following:
(a) any claims made in the advertising are valid and accurate, and all
information presented has been substantiated before the advertising occurs
Example: An ad promotes a medical device for identifying allergies from a non-
invasive sample from the patient. The advertiser states the claim is supported by
a small clinical trial conducted in the 1960s. Subsequent larger studies failed to
reproduce the positive findings. The claims are not valid.
35
37. S.9 - Accuracy: truthful & not misleading
Advertising for therapeutic goods must satisfy the following:
(b) it is truthful, balanced and not misleading or likely to
mislead, including in its claims, presentations,
representations and comparisons
36
38. S.9 – Accuracy: truthful & not misleading
Example: an imaging device is advertised as producing 5 times less radiation
than other devices but fails advise that the amount of radiation produced by such
devices is very small
• the ad is likely to mislead consumers into thinking other imaging devices are
harmful
• It is also likely to mislead consumers as to the order of magnitude of the
difference in radiation produced by the devices – even if the claim is
substantiated.
37
39. S.9 – Accuracy: comparisons
Advertising for therapeutic goods must satisfy the following:
(c) any comparisons made in the advertising between therapeutic
goods or classes of therapeutic goods do not directly or indirectly
claim that the goods or class of goods being used as the comparator
are harmful or ineffectual;
Example: A head lice product is promoted as being more effective and
safer than the leading brand, which has an ingredient shown to cause
birth defects
38
40. S.9 - Accuracy: consistency with ARTG
Advertising for therapeutic goods must satisfy the following:
(d) if the goods are included in the Register— it is consistent with the
entry for the therapeutic goods in relation to that inclusion.
Example: A product is included in the ARTG for the relief of pain in adults
aged 18-65 only. If the product was promoted for pain relief for children, it
would contravene s.9(d).
39
41. S.10 – Effect: support proper use
(a) Advertising for therapeutic goods must support the safe and proper
use of therapeutic goods by:
(i) presenting the goods in accordance with directions or instructions
for use; and
(ii) not exaggerating product efficacy or performance;
Example: A topical preparation for the relief of symptoms of eczema is
promoted for oral consumption as it works faster
40
42. S.10 – Effect: delaying appropriate treatment
(b) Advertising for therapeutic goods must…not be likely to lead to people
delaying necessary medical attention or delaying the use of, or failing to
use, treatment prescribed by a medical practitioner;
Example: a herbal medicine is promoted as an alternative to antibiotics
and people should use it as first line treatment for conjunctivitis and other
infections instead of antibiotics
41
43. S.10 – Effect: encourage inappropriate use
(c) Advertising for therapeutic goods must not encourage inappropriate or
excessive use of the therapeutic goods
Example: A medical device for alleviating snoring is promoted for
alleviating sleep apnoea. The advertising would be likely to encourage
inappropriate use.
42
44. S.10 – Effect: safe or cannot harm
(d) Advertising for therapeutic goods must not contain any claim,
statement, implication or representation that:
(i) the therapeutic goods are safe or that their use cannot cause
harm, or that they have no side-effects
Example: A herbal medicine is promoted as having a safe mode of action
and that millions of people have bought it and there have been no
adverse reports.
43
45. S.10 - Effect: sure cure
(d) Advertising for therapeutic goods must not contain any
claim, statement, implication or representation that…
(ii) the therapeutic goods are effective in all cases of a
condition or that the outcome from their use is a
guaranteed or sure cure;
Example: A medical device is promoted as guaranteed to
improve lung function by 75% in COPD patients
44
46. S.10 – Effect: miraculous
(d) Advertising for therapeutic goods must not contain any
claim, statement, implication or representation that…
(iii) the therapeutic goods are infallible, unfailing, magical
or miraculous; or…
Example: A testimonial on a website for a medicine for
relieving cystitis states the product is miraculous and the
symptoms were gone within two hours and did not return.
45
47. S.10 – Effect: harmful consequences
(d) Advertising for therapeutic goods must not contain any
claim, statement, implication or representation that…
(iv) harmful consequences may result from the therapeutic
goods not being used — unless the claim, statement,
implication or representation is permitted under section 42DK of
the Act or approved under section 42DF of the Act.
Example: An ad for a supplement for 65+ year olds is promoted
by stating that retirees won’t be able to continue playing golf and
keeping up with their grandkids unless they use the supplement
46
48. Sections 11 - 13
Mandatory information and statements
47
49. Overview: application of sections
Section 11 Section 12 Section 13
Ad for S3 (App H) medicine
Ad for non-S3 therapeutic good
that allows purchase without
seeing the good
(selected
items only)
Any other ad for non-S3
therapeutic good
Note: other provisions in the Code, including Part 3, will still apply in each case 48
50. S.11: Required statement – S3s
• An advertisement for a medicine containing a substance included in Schedule
3 of the Poisons Standard and Appendix H must prominently display or
communicate:
ASK YOUR PHARMACIST—THEY MUST DECIDE IF THIS PRODUCT IS
RIGHT FOR YOU
• This is the only mandatory statement required by Part 2 for S3 medicines
advertising
– Part 3 still applies – e.g. analgesics warning
• Does not apply to labels, CMIs or PILs
49
51. Section 12 & 13 requirements
Ad must prominently display or communicate:
• Basic info about the goods
• Important health information (or a prompt to consumers to read it)
• Advice to follow directions
• A symptom statement (if there are claims about symptoms
50
52. S.12: What must ads contain (goods not
available for inspection)
• This section is only for ads for goods that are not available
for physical examination by the consumer before or at the
time of purchase (e.g. internet, mail order marketing)
• Does not apply to:
– advertisements subject to section 11
– a label, consumer medicine information or a patient
information leaflet
51
53. Section 12 mandatories: medicines
Type of information Provision and the information required in ad
Basic information
about the goods
• ss.12(3)(a) – (c) – the name of the medicine, dosage form, the
quantity of the medicine
• ss.12(3)(d) - one or more of the indications for the medicine,
as they appear on the medicine’s label
• ss.12(3)(e) - a list of certain ingredients – see definition in s.4
Important health
information
• ss.12(3)(f) – an alert to the consumer to read the label or
warnings (as appropriate for the nature of the medicine)
Follow the directions
statement
• ss.12(3)(g) – ‘Follow the directions for use’ or ‘Follow the
instructions for use’ from ss.13(6)
Symptom statement • ss.12(3)(h) - If there are symptoms claims in ad, include
appropriate statement/s from ss.13(7) 52
54. ss.12(3)(f): Important health info for medicines
Are there health warnings
in Schedule 1 of the Code
for the medicine?
Do you want to include the health
warnings in the ad?
USE: ‘This medicine may not be right for
you. Read the warnings before purchase’
followed immediately by information about
where the health warnings can be found
USE: ‘Always read the
label’ and the health
warnings
USE: ‘Always read the
label’
NoYes
No Yes
53
55. Section 12 mandatories: devices
Type of information Provision and the information required in ad
Basic information
about the goods
• ss.12(4)(a) – (b) – an accurate description and a reference to
EITHER the trade name or another name for the device
• ss.12(4)(c) – the intended purpose or indications for the device
as they appear on label or primary packaging
• ss.12(4)(d) - a list of the ingredients if applicable
Important health
information
• ss.12(4)(e) – an alert to the consumer to read the label,
instructions or warnings (as appropriate for the device)
Follow the directions
statement
• ss.12(4)(f) – ‘Follow the directions for use’ or ‘Follow the
instructions for use’ from ss.13(6) as appropriate for the device
Symptom statement • ss.12(4)(g) - If there are symptoms claims in ad, include
appropriate statement/s from ss.13(7) 54
56. ss.12(4)(e): Important info for devices
Are there statements on the label or instructions
for use for the device that meet the definition of
‘health warning’ in section 4 of the Code?
Do you want to include the health
warnings in the ad?
USE: ‘This product may not be right for you.
Read the warnings before purchase’
followed immediately by information about
where the health warnings can be found
USE: ‘Always read the
label/instructions for use’
and the health warnings
USE: ‘Always read the
label/instructions for use’
NoYes
No Yes
55
57. Section 12 mandatories: OTGs
Type of information Provision and the information required in ad
Basic information
about the goods
• ss.12(5)(a) – (b) – an accurate description and a reference to
EITHER the trade name or another name for the goods
• ss.12(5)(c) – the intended purpose or indications for the goods
as they appear on label or primary packaging
• ss.12(5)(d) - a list of the ingredients where relevant
Important health
information
• ss.12(5)(e) – an alert to the consumer to read the label,
instructions or warnings (as appropriate for the goods)
Follow the directions
statement
• ss.12(5)(f) – ‘Follow the directions for use’ or ‘Follow the
instructions for use’ from ss.13(6) as appropriate for the goods
Symptom statement • ss.12(5)(g) - If there are symptoms claims in ad, include
appropriate statement/s from ss.13(7) 56
58. ss.12(5)(e): Important info for OTGs
Are there statements on the label or instructions
for use for the goods that meet the definition of
‘health warning’ in section 4 of the Code?
Do you want to include the health
warnings in the ad?
USE: ‘This product may not be right for you.
Read the warnings before purchase’
followed immediately by information about
where the health warnings can be found
USE: ‘Always read the
label/instructions for use’
and the health warnings
USE: ‘Always read the
label/instructions for use’
NoYes
No Yes
57
60. S.13: What must ads contain (general)
• This section is only for ads that:
– are for goods other than Schedule 3 medicines (see
s.13(1)(d) - section 11 applies to these)
– do not facilitate purchase of the goods without the
consumer being able to inspect them (see s.13(1)(e) -
section 12 applies to these)
• This section does not apply to labels, consumer medicine
information or a patient information leaflet (s.13(1)(a) & (b))
59
61. S.13: What must ads contain (general)
• This section also does not apply to picture/price/point of
sale ads (see s.13(1)(c)) – i.e.:
– an advertisement displaying only the name or picture of
therapeutic goods or their price or point of sale, or any
combination of these, provided the advertisement does
not contain or imply a claim relating to therapeutic use,
or any other representation
60
62. Section 13 mandatories: medicines
Type of information Provision and the information required in ad
Basic information
about the goods
• ss.13(2)(a) – (b) – a reference to the trade name of the
medicine and one or more of the indications as they appear on
label
Important health
information
• ss.13(2)(c) – an alert to the consumer to read the label,
instructions or warnings (as appropriate for the goods)
Follow the directions
statement
• ss.13(6) – ‘Follow the directions for use’ or ‘Follow the
instructions for use’ as appropriate for the goods
Symptom statement • ss.13(7) - If there are symptoms claims in ad, include
appropriate statement/s
61
63. ss.13(2)(c): Important info for medicines
Are there health warnings in Schedule 1 of the
Code for the medicine?
Do you want to include the health
warnings in the ad?
USE: ‘This medicine may not be right for
you. Read the label before purchase’
USE: ‘Always read the
label’ and the health
warnings
USE: ‘Always read the
label’
NoYes
No Yes
62
64. Section 13 mandatories: devices
Type of information Provision and the information required in ad
Basic information
about the goods
• ss.13(3)(a) – (b) – an accurate description and a reference to
EITHER the trade name or another name for the device
• ss.13(3)(c) – the intended purpose or indications for the device
Important health
information
• ss.13(3)(d) – an alert to the consumer to read the label,
instructions or warnings (as appropriate for the device)
Follow the directions
statement
• ss.13(6) – ‘Follow the directions for use’ or ‘Follow the
instructions for use’ as appropriate for the device
Symptom statement • ss.13(7) - If there are symptoms claims in ad, include
appropriate statement/s
63
65. ss.13(3)(d): Important info for devices
Are there statements on the label or instructions for
use for the device that meet the definition of ‘health
warning’ in section 4?
Do you want to include the health
warnings in the ad?
USE: ‘This product may not be right for you. Read the
label/instructions for use before purchase’
depending on whether there is a label visible on
primary pack
USE: ‘Always read the
label/instructions for use’
and the health warnings
USE: ‘Always read the
label/instructions for use’
NoYes
No Yes
64
66. Section 13 mandatories: OTGs
Type of information Provision and the information required in ad
Basic information
about the goods
• ss.13(4)(a) – (b) – an accurate description and a reference to
EITHER the trade name or another name for the goods
• ss.13(4)(c) – the intended purpose or indications for the goods
Important health
information
• ss.13(4)(d) – an alert to the consumer to read the label or
instructions (as appropriate for the goods)
Follow the directions
statement
• ss.13(6) – ‘Follow the directions for use’ or ‘Follow the
instructions for use’ as appropriate for the goods
Symptom statement • ss.13(7) - If there are symptoms claims in ad, include
appropriate statement/s
65
67. ss.13(4)(d): Important info for OTGs
Are there statements on the label or instructions for
use for the goods that meet the definition of ‘health
warning’ in section 4?
Do you want to include the health
warnings in the ad?
USE: ‘This product may not be right for you. Read the
label/instructions for use before purchase’
depending on whether there is a label visible on
primary pack
USE: ‘Always read the
label/instructions for use’
and the health warnings
USE: ‘Always read the
label/instructions for use’
NoYes
No Yes
66
68. Exemptions from parts of section 13: short form
ads
• “Short form ads” are:
– Radio commercials 15 seconds or less duration
– Text-only ads of 300 characters or less with no ability to include
pictures, logos or other imagery
• Short form ads are exempt from:
– The calls to action – ‘Always read the label’ etc
– Symptoms statement (ss.13(6))
67
73. S.15: Scientific or clinical representations
• Ss.15(1) - this section does not apply to labels, CMIs or
PILs
• This section is in two parts:
– Requirements for use of scientific or clinical claims
(ss.15(2))
– Requirements for use of citations (ss.15(3))
72
74. S.15(2): Scientific or clinical claims
Where an advertisement makes a scientific or clinical claim:
• (a) any scientific or clinical terminology must be
appropriate, clearly communicated and able to be readily
understood by the audience to whom it is directed; and
• (b) any scientific or clinical representation must be
consistent with the body of scientific or clinical evidence
applicable to the advertised therapeutic goods.
73
75. S.15(3): Scientific citations
Where an advertisement contains a citation to scientific or
clinical literature, either explicitly or impliedly:
• (a) any research results must identify the researcher and
financial sponsor of the research, where the advertiser
knows, or ought reasonably to have known that
information; and
• (b) the study must be sufficiently identified to enable
consumers to access it. 74
76. Example Implied scientific
citation – reference
needs to be
provided
Scientific
information is
inappropriate and
won’t be readily
understood
These would need
to reflect the body
of evidence
available
75
78. S.16(1): Endorsements
• The endorsement provisions in section 16 do not apply to:
– Testimonials captured by section 17 (s.16(1)(a))
– Claimer for efficacy assessed non-prescription medicines
– as described in Regulations (s.16(1)(b))
77
79. S.16(2) and (2A): Endorsements
• Endorsements (express or implied) from the following are
prohibited:
(a) a government authority, hospital or healthcare facility; or
(b) an employee or contractor of a government agency,
hospital or healthcare facility; or
(c) a health practitioner, health professional, medical
researcher or a group of such persons.
• Health care facilities do not include community pharmacies
78
80. S.16(3): Endorsements
Subject to conditions, endorsements from the following are permitted:
(a) an organisation that:
(i) represents the interests of healthcare consumers; or
(ii) represents the interests of health practitioners, health
professionals or medical researchers; or
(iii) conducts or funds research into any disease, condition,
ailment or defect; or
(b) an employee or contractor of an organisation mentioned above,
other than an individual mentioned in paragraph (2)(b) or (c) 79
81. S.16: Endorsement conditions
• Endorsements made under s.16(3) are subject to the conditions
that the advertisement:
– names the organisation concerned; and
– discloses:
(i) the nature of the endorsement; and
(ii) whether the organisation or employee, has received, or
will receive, any valuable consideration for the
endorsement
• ‘Organisation’ defined in s.16(4) – any group, association etc 80
82. S.17: Testimonials
• Testimonial = a statement about a therapeutic good made by
a person that claims to have used that good (s.17(1))
• This section specifies three types of requirements:
– Characteristics of the person making testimonial
(s.17(2)(a))
– Obligations of the advertiser before using testimonial in
advertising (s.17(2)(b) and (c))
– Information that must be disclosed in the ad about the
testimonial (s.17(3)) 81
83. Who can make a testimonial for use in ads?
s.17(2)(a) - a person:
I. whose details are verified prior to the advertising occurring; and
II. who has used the goods for their intended purpose; and
III. iii who is not:
A. involved with the production, sale, supply or marketing of the goods; or
B. an employee or officer of a corporation that is involved with the production,
sale, supply or marketing of the goods; or
C. a corporation; or
D. mentioned in subsection 16(2) (e.g. health professionals, staff from
government agency, hospital or healthcare facility)
82
84. Advertiser obligations when using testimonials
s.17(2)(b) and (c) – the advertiser needs to ensure that they
have:
• verified as to the use of the goods and the claims made by
the person prior to the advertising occurring; and
• checked that the testimonial is typical of the results to be
expected from the use of the goods in accordance with the
directions for use, or purpose, of the goods.
83
85. Information re testimonials to be included in ads
s.17(3) – An ad containing a testimonial must:
(a) disclose whether the person providing the testimonial has
received, or will receive, any valuable consideration for the
testimonial;
(b) disclose where another person is taking the place in the
advertisement of the person providing the testimonial; and
(c) disclose where the person providing the testimonial is an
immediate family member of an individual who is involved with
the production, sale, supply or marketing of the goods.
84
87. Example acceptable use policy
• We welcome your comments on our page but we ask that you help us comply with the Therapeutic Goods Advertising Code (the
Code).Please consider these guidelines before commenting. We will remove any comments that may result in us breaching the
Code.
• We love when you comment and tag your friends and family on our posts but we ask that you do not:
• endorse our product if you are:
– an employee or contractor of a government authority, a hospital or a healthcare facility
– a health practitioner, health professional or medical researcher
– involved with the production, sale, supply or marketing of our product
– not using your own name on this social media platform.
• imply that a government authority, a hospital or a healthcare facility endorse our product
• make comments about how a product works for you outside of its intended purpose, as these comments can be dangerous or
misleading.—our products are developed for particular purposes, as stated on the label and/or in our advertising, and these
comments can be dangerous and misleading
– make comments about serious conditions, diseases, ailments or defects, such as comments about how a product helped
with your cancer treatment or how it will relieve a tagged person’s rheumatoid arthritis pain
• We also have an obligation to make sure any advertisements we make, including endorsements and testimonials, are not
misleading. Therefore we promise to disclose:
• where a person has been, or will be, compensated for making a testimonial
• where we have actors making the testimonial, such as in cases where the original person who made the testimonial does not
want to appear in our advertisement
• where the person making the testimonial is an immediate family member of anyone employed by our business
86
88. S.18: Incentives
• Ads must not offer any personal incentive to a pharmacy
assistant, or any retail sales person who is not a health
professional, to recommend or supply therapeutic goods.
• Pharmacy assistants and other retail staff do not meet the
criteria for ‘health professionals’ for the purposes of the
advertising (s.42AA)
• Ads for these audiences must comply with the Code –
including this provision
87
89. S.19: Advertising to children
• Advertising must not be primarily directed to children under
the age of 12 years at all
• Advertising must not be primarily directed to children aged
12 years or over, EXCEPT for those products listed in
Schedule 2, which include tampons and condoms
• Labels are excluded from this provision
• ‘primarily directed’ does not include incidental exposure
88
90. S.20: Samples
• An ad must not contain an offer of a sample EXCEPT for those products listed
in Schedule 3:
condoms
Sunscreens
Stoma devices for self-management
Continence catheter devices for self-management
• Samples can in themselves be an ad – consider Act definition of ‘advertise’
• Some samples may also be subject to state and territory laws – e.g. scheduled
substances
89
91. S.20: Samples example
NOT COMPLIANT
Have you been diagnosed with IBS recently?
Wondering if you will ever find anything to help your symptoms?
You can feel better in just two weeks – take the Bean’s challenge!
Sign up at www.beanstonic.com.au and we will email you a voucher for a free one
month supply of Bean’s Tonic from your local pharmacy
90
92. S.21: Consistency with public health campaigns
• If a relevant public health campaign of which the advertiser
knows, or ought reasonably to have known is or will be current
at the time of advertising therapeutic goods, the advertising
must not be inconsistent with the public health campaign
• Campaigns can be current but not necessarily active – e.g.
respiratory hygiene campaigns only run in cold & flu season
• Guidance contains more information on establishing current
public health campaigns
91
93. S.21: Consistency with public health campaigns
Example: There are a
range of current initiatives
in Australia to encourage
responsible alcohol
consumption
NOT COMPLIANT
Drinkers Delight
liver tonic
• improves liver function
• protects the liver from damage from
alcohol consumption – especially on
a big night out!
Cheers!
92
94. S.21: Consistency with public health campaigns
Example: National
tobacco campaign –
an ongoing campaign
to promote the quit
smoking message
across the national
population
NOT COMPLIANT
SmokeProtect
Natural antioxidants to protect
the lungs from toxins in cigarette
smoke
Just one daily dose
provides all the protection you
need
93
95. 94
Part 3 - Requirements when advertising
particular types of therapeutic goods
96. S.22 - Application
• Part 3 of the Code does not apply to:
– Labels (as defined in s.3 of the Act)
– Consumer medicine information leaflets (patient
information documents as defined in Regs)
– Patient information leaflets (implantable medical devices
– see s.4 - Definitions)
• These documents can still be considered promotional and
have to comply with all other relevant Code provisions
95
97. S.23 – Complementary medicines
If an advertisement for a complementary medicine includes a
claim or group of claims based on evidence of a history of
traditional use, the reliance on this traditional use and
paradigm must be disclosed in the advertisement and the
disclosure must be prominently displayed or communicated
in the advertisement.
• This provision provides clarity around expectations for
medicines advertised on the basis of traditional use
96
98. S.23 – Complementary medicines
• Some medicines rely on multiple paradigms – if this is the
case, they need to be included in the ad.
• Example:
Traditionally used in Ayurvedic medicine to relieve
sleeplessness. Traditionally used in western herbal medicine
to soothe restlessness.
Ingredient X is traditionally used in Ayurvedic and western
herbal medicine to soothe sleeplessness and restlessness.
97
99. S.24 – Analgesics
• Oral analgesic ads must prominently display or communicate:
INCORRECT USE COULD BE HARMFUL
• The ad must not imply that analgesic consumption is safe or they
can relax, relieve tension, sedate or stimulate
• Definition of analgesic in s.4 – excludes combinations of analgesic
and other ingredients for self limiting conditions
• Needs to be used in conjunction with other mandatories
• For radio ads 15s or less - FOLLOW THE DIRECTIONS FOR USE.
INCORRECT USE COULD BE HARMFUL. 98
100. S.25 – Vitamins and minerals
An advertisement for vitamin or mineral supplements must
not claim or imply that the supplements:
• (a) are a substitute for good nutrition or a balanced diet; or
• (b) are in any way superior to or more beneficial than
dietary nutrients.
99
101. S.26 – Goods for weight management
(1) An advertisement for therapeutic goods containing any claim
relating to weight management must balance the claims with
the need for a healthy energy-controlled diet and physical
activity.
(2) Advertising of therapeutic goods containing any claim relating
to weight management must not include any reference or
depiction suggesting that the therapeutic goods will correct or
reverse the effects of overeating or over-consumption of any
food or drink.
100
102. S.26 – Weight management
(3) An advertisement for therapeutic goods containing any claim
relating to weight management must not:
(a) feature individuals in images or visual representations; or
(b) use individuals’ statistics or testimonials; unless the
results achieved by those individuals from the use of the
goods would be expected to be achieved on average by
users of the goods.
101
103. S.27 – Sunscreens
For an ad for a therapeutic good that is or contains a sunscreen
that is claimed to prevent sunburn or skin cancer, the ad must:
• depict sunscreens as being only one part of sun protection; and
• include statements or visual representations, prominently
displayed or communicated, to the effect that:
– prolonged high-risk sun exposure should be avoided; and
– frequent re-application or use in accordance with directions is
required for effective sun protection.
102
104. Part 4 – Restricted and
prohibited representations
103
105. Prohibited and Restricted Representations
• The Act makes it a criminal offence, and provides civil penalties, where
an advertiser makes reference certain conditions (explicitly, or by
implication) in advertising of therapeutic goods without prior approval:
– S. 42DL(7) and 42DLB(4) – restricted representations
– S. 42DL(5) and 42DLB(2) – prohibited representations
• The Act also provides that the Secretary may approve the use of these
representations under certain circumstances (s.42DF and s.42DK)
104
106. s.29(1)(a) – medically accepted to be
a form requiring
diagnosis, treatment or supervision
by a suitably qualified health
professional?
s.29(1)(a) - Once medically
diagnosed, is it medically accepted to
be suitable
for self-treatment and management?
s.29(1)(b) - Is there a
diagnostic/screening, or other kind
of test for the form which requires
medical interpretation or follow-up?
The form IS a
serious form
NOT a serious form
NO
YES YES
NO
NO
YES
105
107. Restricted representations
• A range of examples of what are and are not considered
serious conditions are provided in the Guidance.
• The conditions included in the Guidance make for a fairly
easy assessment of whether or not they need to be
medically diagnosed.
• Where the serious condition is implied by the
representation, this may be more difficult to assess
106
109. Permitted restricted representations
• TGA has permitted the use of certain restricted representations
by all advertisers of therapeutic goods, where the ad and
product meets the characteristics and requirements specified.
• Permitted restricted representations include:
– Neural tube defect risk reduction in pregnancy when
advertising medicines with at least 400µg folic acid/day
– representations about sleep apnoea, Obstructive Sleep
Apnoea (OSA) and Central Sleep Apnea/Apnoea (CSA) in
relation to Continuous Positive Airway Pressure (CPAP)
equipment 108
111. S.30 - Prohibited representations
• Representations (express or implied) about the treatment, cure,
prevention, diagnosis (including screening), monitoring or
susceptibility of, or pre-disposition to:
– Neoplastic diseases (i.e. all types of cancer)
– Sexually transmitted disease
– HIV/AIDS
– Hepatitis C virus
– Mental illness
• Abortifacient action 110
112. Using prohibited representations
• The use of a prohibited representation may be authorised where
it is necessary for either:
– Public health interest; or
– The appropriate use of the goods (packaging & labelling only)
• There is no process for applying to use prohibited
representations – TGA will identify where it is needed
• Representations about preventing transmission of
STDs/HIV/AIDS and prevention of skin cancer through
sunscreen use are prohibited representations but will be
permitted 111
114. Top tips for compliant 2019 advertising
Ensure ads contain the correct mandatory statements
and information with appropriate prominence
Check advertising for complementary medicines,
analgesics, vitamins, weight loss products and
sunscreens carefully to ensure full compliance with the
express provisions
Don’t use advertising with references to diseases,
conditions, ailments or defects before checking if you
need restricted representation approval 113
115. Top tips for compliant 2019 advertising
Ensure testimonials, endorsements and scientific
representations fully comply with clarified requirements
Don’t use advertising that is inconsistent with the
product’s ARTG entry, directions, or instructions for use
Don’t use advertising that encourages people to delay
seeking medical advice or cease prescribed therapies
Don’t use advertising that conflicts with public health
campaigns 114
116. More information on the 2018 Code
• The 2018 Code:
– Search “Advertising Code” on the TGA website
• The 2018 Code guidance
– Available from the Advertising Code page on the TGA website
• The 2018 Code explanatory statement
– Open the 2018 Code and click on ‘Explanatory statement’ button
• More face to face and webinar education activities planned
• Online training module planned
115
117. More general advertising information
• Advertising hub – www.tga.gov.au/advertising-hub
– Online training module – more to come
– Australian Regulatory Guidelines for Advertising
Therapeutic Goods
• Regulatory affairs consultant / legal advice
• TGA Online advertising inquiry form -
https://compliance.tga.gov.au/advertising-enquiry/
116