Permitted indications for listed medicines Completing the application and tips for transitioning Amanda Fuller Assistant Director, Business Improvement and Support Section Complementary and OTC Medicines Branch, TGA ARCS Annual Conference 21 August 2018
What does this mean for sponsors? • Sponsors listing a medicine on the ARTG can only use indications from the permitted indications list • A permitted indication describes a therapeutic use for a listed medicine • “ Free text ” field is no longer be available • Sponsors must continue to hold supporting evidence for their medicine indications • There must not be inconsistency between the indications that are listed in the Register and on the label • 3 year transition period for existing listed medicines 1
Transition arrangements • From 6 March 2018 , all new listed medicines must select permitted indications ( free text has been turned-off) • Sponsors of existing listed medicines will be required to transition their existing indications to ‘permitted indications’ by 6 March 2021 : - Except if making a ‘grouping’ change - AUST L numbers will not change (where ‘grouping’ applies) - Fee waiver if indications changed by 6 September 2019 • Listed medicines that do not transition to permitted indications will be cancelled from the ARTG from 6 March 2021 2
Finding your indications • All listed medicine indication information and associated restrictions will also be available in an online database • Updates to the online database will be made to match updates to the Permissible Indications Determination • Ability to conduct searches using indication information such as; key words, phrases, evidence requirement or body part/system 3
Transitioning your medicine • Step 1: Ensure your medicine is eligible for listing • Step 2: Review the evidence that you hold for your permitted indications • Step 3 : Complete the online application • Step 4: Select indications and qualifiers to align with the evidence you hold. • Step 5 : Ensure that the medicine label is compliant with all necessary regulatory requirements 4
Step 1: Ensure your medicine is eligible for listing Is your medicine eligible for listing? Approved Preparation not in Qty restrictions not Not required to ingredients Poison Standard exceeded be sterile Must only make permitted indications Sponsor certifies that the medicine is eligible for listing Product is listed – assigned ARTG number (AUST L XXXX) 5
Step 2: Review the evidence for your medicine • Sponsor must hold evidence for all indications and claims • Best practice to review your evidence to make sure they supported your indications • Permitted indications are categorised by the evidence type that can be used to support: - General, traditional or scientific • General indications can be supported by either scientific evidence or a tradition of use 6
Step 4: Using permitted indications 4. Select specifying qualifiers (Optional) 2. Select core 3. Select linked 1. Select tradition of permitted indication indication use (* Mandatory) (Optional) (Optional) Healthy target Time of use population Linked indication Core permitted Tradition of use Specifying qualifiers indication Relieve abdominal bloating Healthy target population: ‘in adults’ Traditionally used in Relieve symptoms of Time of use: ‘after eating’ Chinese medicine to indigestion Relieve cramping Final permitted indication on product label Traditionally used in Chinese medicine to relieve symptoms of indigestion, such as abdominal bloating and cramping after eating in adults.
Step 5: Including indications on medicine label • Some indications have specific requirements relating to the use of the indication in the medicine • The wording of indications can be altered on your label or advertising material provided the intent and meaning of the indication does not change: • ARTG indication: ‘ Maintain/support gastrointestinal health’ • Label indication - same meaning: ‘ Maintains healthy gut • Label indication - different meaning: ‘ Maintain healthy intestinal flora ’ • A number of indications could be linked together in a simple sentence Helps decrease/ • Helps decrease/reduce/relieve cough Relieve symptoms of common reduce/relieve • Helps decrease/reduce/relieve watery eyes cold such as cough, runny symptoms of nose and itchy eyes • Helps decrease/reduce/relieve nose common cold 8
Other things to consider when transitioning • Changing product name or making other ‘grouping changes • Manufacturers - Expired clearances • Ingredient requirements - 26BB Permissible Ingredients Determination updated • Ingredients of animal origin - New Transmissible Spongiform Encephalopathies (TSE) Guidelines 9
What if my indication is not on the permitted list? • Apply to add a new indication to the list and then apply to list their product; OR • If the medicine has higher-level indications, apply to list their medicine through the new assessed list medicine pathway 10
Find out more https://www.tga.gov.au/assessed-listed-medicines complementary.medicines@health.gov.au
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