Permitted indications for listed medicines Completing the - - PowerPoint PPT Presentation

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

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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

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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

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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

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Step 1: Ensure your medicine is eligible for listing

Is your medicine eligible for listing?

Approved ingredients Preparation not in Poison Standard Qty restrictions not exceeded Not required to 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)

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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

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Step 4: Using permitted indications

• 1. Select tradition of

use

(Optional)

• 2. Select core

permitted indication (* Mandatory)

• 3. Select linked

indication

(Optional)

• 4. Select specifying qualifiers

(Optional)

Healthy target population Time of use

Tradition of use Traditionally used in Chinese medicine to Core permitted indication Relieve symptoms of indigestion

Linked indication

Relieve abdominal bloating

Relieve cramping

Specifying qualifiers Healthy target population: ‘in adults’ Time of use: ‘after eating’

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/ reduce/relieve symptoms of common cold

• Helps decrease/reduce/relieve cough
• Helps decrease/reduce/relieve watery eyes
• Helps decrease/reduce/relieve nose

Relieve symptoms of common cold such as cough, runny nose and itchy eyes

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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

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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

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Find out more

https://www.tga.gov.au/assessed-listed-medicines complementary.medicines@health.gov.au

Questions?