SME Assist Meeting Your Obligations Market Authorisation Dr Jayne - PowerPoint PPT Presentation

SME Assist – ‘Meeting Your Obligations’ Market Authorisation Dr Jayne Foster Assistant Director, SME Assist 12 November 2019

Disclaimer This material is provided to you solely for the purpose of providing a record of today’s presentation. The presentation is not legislative in nature and should not be taken to be statements of any law or policy in any way. The Australian Government Department of Health (of which the TGA is a part) advises that: a) the presentation paper should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and b) it cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper. 1

Manufacturing Market authorisation 2

Market Authorisation Market Authorisation 3

Medicines and Medical devices biologicals All therapeutic goods Market Authorisation 4

 Therapeutic good development lifecycle Dept Health Pre-TGA TGA Clinical Clinical trial trial Subsidy* notification Pre-market Processing Post-market Subsidy design, / exemption funding Make your Design and Get approval Get approval to product more get approval to use your supply your product affordable to run clinical product in (‘ market authorisation ’) trials clinical trials for consumers *subsidisation is not guaranteed and will not be granted prior to ARTG inclusion Market Authorisation 5

Market authorisation Identify your product Use the  Is my product a therapeutic Ask the manufacturer of the device good? decision tool Look at labels, instructions and advertising material Search the  Australian Register of Therapeutic Goods ( ARTG) for similar Use the Is my product a therapeutic products good? and  What classification is my medical device? decision tools Search the  ARTG for similar products Market Authorisation 6

Market authorisation Consult the Australian Regulatory Guidelines to find out what’s required in your application Complementary ARGCM medicines ARGMD Medical devices Over-the-counter ARGOM medicines Prescription ARGPM medicines ARGB Biologicals Market Authorisation 7

Market authorisation International assessment Comparable overseas regulators Comparable overseas regulators for prescription medicines These currently include: These currently include: • Canada • Canada • European Union • European notified bodies • Japan • Japan • Singapore • United States of America • Switzerland • Certificates and reports issued • United Kingdom under the Medical Device Single • United States of America Audit Program   Market Authorisation 8

Market authorisation Ingredients and indications Example: • Permissible ingredients What does it contain? • Substances in the Poisons Standard Example: ‘ Helps promote general health and What claims are you making? wellbeing’ versus ‘cures diabetes’  Market Authorisation 9

Market authorisation Labelling requirements Prescription medicines: Essential Principles 13.1, 13.2, 13.3   TGO 91 labelling Order (labelling) Non-prescription medicines: Essential Principle 13.4   TGO 92 labelling Order (instructions for use)  Biologicals: Part 10.2 of the  TGO 87 labelling Order Therapeutic Goods (Medical Devices) Regulations 2002 (sponsor information) Market Authorisation 10

Market authorisation Online application • Create an account in TGA Business Services (TBS) • Log into your TBS account • Complete relevant fields and agree to the declaration • Review and submit • Pay application fees  Market Authorisation 11

CASE STUDY: Alex and her listed medicine label Market Authorisation 12

Market authorisation Labelling requirements 60 capsules Market Authorisation 13

Directions for use: Take one capsule once daily 60 capsules Market Authorisation 14

Market authorisation The permissible indications Labelling requirements determination – label must include ‘Adults only’ AND an ‘if symptoms persist…’ statement. Contains crustacean shellfish. Vitamin supplements should not replace a balanced diet. Address: 52 Wallaby Way 60 capsules Sydney Market Authorisation 15

SME Assist 16

SME Assist www.tga.gov.au/sme-assist 1800 020 653 sme.assist@tga.gov.au 17