COMPLIANCE SUSAN DANKS AND IMPORT/ HEAD OF CUSTOMS EXPORT AND - PDF document

12/05/2020 COMPLIANCE SUSAN DANKS AND IMPORT/ HEAD OF CUSTOMS EXPORT AND REGULATORY COMPLIANCE DURING FREIGHT & TRADE COVID-19 ALLIANCE (FTA) 1 • Part of Federal Department of Health • Regulates medicines, biologicals and devices, including medicines, vaccines, sunscreens, vitamins and minerals, medical THE THERAPEUTIC devices, blood and blood products. GOODS • TGA does not regulate veterinary medicines ADMINISTRATION and appliances, cosmetics or chemicals (TGA) • Australian Register of Therapeutic Goods (ARTG) • Sponsors 2 1

12/05/2020 What is a Therapeutic Good Listing on the Australian Register of Therapeutic Goods (ARTG) TGA REGULATION Registration as a sponsor Goods not complying with the above are a Prohibited Import 3 Medical devices must be entered on the ARTG before they can be lawfully: • manufactured for supply within Australia or elsewhere; • supplied in Australia; ARTG • imported into Australia; • exported from Australia; • arranged to import, export or manufacture the therapeutic goods. 4 2

12/05/2020 A sponsor is the name for the person or company who is legally responsible for supplying a device in Australia is called the “sponsor”. “Supply” includes sale, exchange, gift, lease, loan, hire or hire purchase. SPONSORS Devices and medication can only be imported and supplied by the approved Sponsor (i.e. importer), or a person acting on their behalf 5 PENALTIES FOR NON COMPLIANCE Civil or Up to 5 years 5000 penalty criminal imprisonment; units penalties and/or 6 3

12/05/2020 • TGA is offering an expedited assessment process for all medical devices associated EXPEDITED with the detection, prevention and COVID-19 treatment of COVID-19. MEDICAL • To ensure applications are rapidly assessed DEVICE TGA once an application has been submitted, APPROVAL sponsors should email devices@tga.gov.au and provide supporting technical files and PROCESS data for assessment. 7 • Refer Principle 13 of Sch 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 • All labels must include the manufacturer's name and address; LABELLING OF • All labels must include instructions for use and MEDICAL other prescribed information. Refer the Regulations but it may include batch numbers, DEVICES use by date/date of manufacture, handling, storage, warnings, restrictions as to use, special operating instructions. As well as if its for single use, and/or sterile 8 4

12/05/2020 • The supply of self test-kits is prohibited under the Therapeutic Goods (Excluded TEST KITS Purposes) Specification 2010 INCLUDED • Emergency exemption for some diagnostic ON THE kits to all (inc public and private) Australian accredited pathology laboratories under ARTG FOR the Therapeutic Goods (Medical Devices— SUPPLY IN Accredited Pathology Laboratories) (COVID- AUSTRALIA 19 Emergency) Exemption 2020 9 HAND SANITISERS • These are either: • A cosmetic regulated by ACCC / NICNAS; or • A therapeutic good regulated by TGA • The control depends upon how they are used/ advertised. • NB: Some TGA products are excluded for the duration of the pandemic 10 5

12/05/2020 • are for personal or domestic use only and not for use in a health care setting (inc aged care homes), and HAND • have claims that are limited to general low-level SANITISERS activity against bacteria or germs (for example, ARE NOT kills 99.9% of germs), and REGULATED BY • have no claims against viruses, and TGA IF THEY: • contain only low-risk ingredients (i.e. does not contain a substance included in Schedules 2, 3, 4 or 8 of the Poisons Standard). 11 HAND SANITISERS REGULATED BY NICNAS / ACCC The controls on these The Therapeutic goods are exercised by Goods (Excluded NICNAS / ACCC: Hand sanitisers Goods) that are cosmetics • NICNAS regulates the Determination can only make ingredients used in goods 2018 sets out the regarded as cosmetics. general claims circumstances • The ACCC regulates the such as that the when antibacterial labelling of goods product "kills skin preparations regarded as cosmetics. 99.9% of germs". are not therapeutic goods. 12 6

12/05/2020 • These • claim to kill specific organisms (e.g. E.coli or viruses), and/or HAND • are to be used in clinics or hospitals. • They must be on the Australian Register of SANITISERS REGULATED BY Therapeutic Goods (ARTG); and THE TGA • The importer / manufacturer must be registered with TGA as a sponsor even if identical goods are produced / manufactured by other parties. 13 CERTAIN The final formulation of the hand sanitiser must contain only the following ingredients: SPECIFIC EITHER ethanol 80% v/v (pharmacopoeial grade or food standard grade) OR HAND isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution; SANITISERS sterile distilled water or boiled cold water; ARE EXCLUDED FROM TGA glycerol 1.45% v/v (pharmacopoeial grade); FOR THE hydrogen peroxide 0.125% v/v (pharmacopoeial grade); and DURATION OF THE PANDEMIC does not contain any other active or inactive ingredients, including colours, fragrances or emollients. 14 7

12/05/2020 HAND SANITISERS ARE A DANGEROUS GOOD 15 DANGEROUS GOODS - AIRCRAFT • Specimens of Covid-19 being shipped to laboratories for analysis or confirmation of diagnosis as cargo and potentially in mail; • Alcohol-based hand sanitizers as air cargo • Alcohol-based hand sanitizers uplifted in the cabin for use by crew members as operator equipment; and • Alcohol-based hand sanitizers carried by passengers and crew members in checked and carry-on baggage. 16 8

12/05/2020 SUSPECTED COMMUNICABLE DISEASE: GUIDELINES FOR CARGO AND BAGGAGE HANDLERS • Hand sanitiser containing alcohol is a Dangerous Good for carriage; • During the Severe Acute Respiratory Syndrome (SARS) outbreak, the WHO declared there was no evidence that the infection had been or could be transmitted by cargo or baggage handling, but • Don’t handle packages visibly dirty from blood or body fluids. • Wash your hands often to prevent other infectious diseases. . 17 SAFETY DATA SHEETS ARE REQUIRED FOR ALL HAND SANITISERS, REGARDLESS OF THE CLASS, WITH DATA INCLUDING the chemical’s identity and ingredients safe handling and storage procedures . health and physical hazards disposal considerations first aid and firefighting methods • In response to the COVID-19 pandemic, UL is making SDS for TGA excluded hand sanitisers freely available to manufacturers and importers. Refer their website. • Safe Work Australia has further information 18 9

12/05/2020 • Regulatory framework managed by TGA applies to any goods intended for use in a therapeutic environment • New importers should be referred to TGA IMPORTING website if not familiar with the requirements COVID-19 https://www.tga.gov.au/industry and the video at https://tga.gov.au/summary-supplying- PRODUCTS therapeutic-goods-australia INTO • TGA take a risk based approach to importing AUSTRALIA PPE and medical devices • Penalties can apply for importing unregistered goods • Some exemptions apply 19 Enter to bond licensed by both ATO and ABF on a N20 UNDENATURED ETHYL ALCOHOL If the warehouse is licensed to produce or distil spirits no further action is required by you. If not so licensed, IMPORTED TO they should apply – applications are being fast MANUFACTURE tracked. HAND SANITISER The bond warehouse will lodge a N30 at the end of its settlement period to acquit the deliveries made into the Australian domestic market and/or the excise equivalent imported goods used in excise manufacture during that period. 20 10

12/05/2020 PERSONAL PROTECTIVE EQUIPMENT (PPE) E.G. FACE MASKS, GLOVES, FACE SHIELDS, GOGGLES AND GOWNS 21 PPE / MEDICAL GOODS IMPORTED WHERE EVIDENCE OF TGA APPROVAL IS NOT HELD • Risk based approach; • ABF will refer goods to TGA for assessment • TGA will determine if goods are in breach of the Therapeutic Goods Act • If they are in breach TGA will issue a direction to ABF and the goods will be seized • Goods not in breach will be released 22 11

12/05/2020 NOT ALL FACE MASKS AND GOWNS ARE REGULATED BY THE TGA Under the Therapeutic Goods (Declared Goods) Order 2019, non sterile protective or safety apparel or equipment such as dust masks is not controlled when of a type promoted and used: • in the home; or • for occupational or recreational use. e.g. dust masks for industry 23 Face masks or gowns, presented, labelled or claimed as therapeutic use, e.g. labelled for surgical use, or to reduce or prevent the transmission of disease or bacteria or viruses, meet the definition of a medical device and are regulated by the TGA under the Act. PPE REGULATED ARTG listing required BY TGA Sponsor required 24 12