YESTERDAY I was contacted by Michelle Fitzgerald from the Regulatory Education and Compliance Branch of the Therapeutics Goods Administration (TGA) who provided us with a newly released document for circulation that presents clarification of updated regulations to cosmetic injectable products.
CLARIFYING LEGISLATION RELATED TO COSMETIC INJECTABLE PRODUCTS
Below you will find the document provided to us by the TGA for circulation, so, to whom does it apply to?
- NURSES: If you are a nurse delivering injectables please review the document below and ensure that you are complying with regulatory updates.
- SALON OR CLINIC: If you are a clinic or a salon that is contracting a nurse to provide your clients with injectable services please also review this document.
The regulatory scheme is important to the safety of Australian consumers. The Therapeutic Goods Administration (TGA) regulates all medicines, medical devices, and biologicals under the Therapeutic Goods Act 1989 (the Act). The Act prohibits the import, export, manufacture, supply, and advertising of unapproved therapeutic goods for human use, which have not been subject to approvals, exemptions, or permits. Unless a specific exemption applies, a therapeutic good must be entered on the Australian Register of Therapeutic Goods (ARTG), or it cannot be supplied in Australia. Only legal sponsors are permitted to lawfully import therapeutic goods. A sponsor is a person or company that is legally responsible for supplying goods on the ARTG in Australia.
Cosmetic injectables are regulated as Schedule 4 substances (prescription-only medicines). You can not publish an advertisement to the public about therapeutic goods that contains a statement referring to goods, or substances or preparations containing goods, included in Schedules 3, 4 or 8 of the Poisons Standard. Health professionals and cosmetic or beauty clinics are not permitted to advertise references to the active ingredients in cosmetic injections. Abbreviations of either the trade or ingredient names are also unacceptable. Further information is available at advertising cosmetic injections.
Cosmetic injections require a prescription from an accredited professional, and can only be stored and administered by qualified, authorised practitioners. You need to be aware of your obligations under State and Territory legislation for the storage of Schedule 4 substances. Cosmetic injectables are considered high-risk products and clients must be assessed by a medical professional before their use.
THE TGA TAKES ACTION AGAINST ILLEGAL ACTIVITY
The TGA investigates suspected illegal activity relating to therapeutic goods, including unlawfully supplied products. Appropriate regulatory action is taken where necessary, ranging from education and support through to seizure and destruction of unapproved therapeutic goods, fines, and court proceedings. Targeting legislative non-compliance disrupts the illegal trading of unapproved and counterfeit therapeutic goods in the domestic market.
The TGA encourages the reporting of illegal cosmetic injectable procedures in Australia. These reports can prevent potentially serious consequences and safeguard the health of the Australian community.
If you suspect non-compliance regarding cosmetic injectable products, you can report illegal or questionable practices anonymously online to the TGA, or by calling 1800 020 653. You can also, report suspected supply of counterfeit medicines and medical devices. Information provided should include sufficient details for further enquiries to be undertaken.
The Australian Health Practitioner Regulation Agency (AHPRA) can be notified if you have concerns about practitioners.
ADDITIONAL SUPPORT FOR BUSINESS OWNERS
APAN is also working with the NSW Health Minister regarding new regulatory tighter measures regarding cosmetic injectables, which will also soon come into effect. The key issue of concern is that cosmetic injectables are classified as S4 Drugs and therefore carry risk to the client/patient. While procedures delivered in a medical clinic have met the regulatory and licensing requirements for these services this is often not the case when these services are delivered in a non-medical clinic or salon.
ACCESS OUR INJECTABLES SERVICES COMPLIANCE KIT FOR PEACE OF MIND
APAN, in collaboration with the Cosmetic Medicine Alliance urgers all businesses who provide injectable services, or who plan to do so, to contact APAN and access our INJECTABLE SERVICES COMPLIANCE KIT. Please use these documents as your guidelines to ensure that you are meeting with regulatory requirements. As a referring party, you have a duty of care to ensure the safety of your clients as you are also liable under vicarious liability under the law if something goes wrong.
Let’s work together to protect your reputation and for the safety of your clients. These documents will ensure you are operating with sound business and best practice principles. Phone today for these documents. If you are a current APAN member there is no charge. If you are not there is a $50 charge Ph: 07 5593 0360. Why take risks when you can have peace of mind.
HAVE YOU REGISTERED YET?
DO YOU perform skin needling or cosmetic tattooing? If you are providing treatments that target the deeper layers of the skin and induce pain it is imperative that you perform these treatments in a way that ensures your client’s comfort, otherwise they will opt to go to a practitioner who can.
Topical Anaesthetics are drugs that carry risks. Understanding how they work and how to guarantee the complete safety of your client, or patient is a mandatory requirement and your obligation under best-practice.
Introducing an updated face-to-face course on the SAFE USE OF TOPICAL ANAESTHETICS developed by Compounding Pharmacists and educator Chris Testa specifically for the aesthetics and cosmetic tattooing industry.
Chris has updated the curriculum content combining the Introduction and the Advanced Course and has included some cool clinical information that I know you will find amazing.
The date is coming up soon – Monday 3rd March 2020. Why not start the year strong and secure this Industry Accredited Course? It will give you confidence and we know you will gain amazing value for you and your clients.
Please register on-line. The cost is $595 and includes the manual, Certificate, morning and afternoon tea. Location is at the APAN HEAD OFFICE. Unit 7D, 76-84 Robina Town Centre Drive.
9.00am – 5.00pm. There is free parking directly opposite our building.
If you have completed the online course the cost for this one will only be $395.If you are a cosmetic tattooist or perform skin needling this course is a “must”. PLEASE RESERVE THIS DATE.