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Changes to propolis and royal jelly in listed medicine applications

29 October 2019

The TGA has changed the listed medicine application system to allow equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the ARTG. Sponsors can now enter propolis and royal jelly[1] preparations with equivalent starting material in a way that accurately reflects the active ingredient contained in their medicine.

Sponsors of existing listed medicines should review this information before 31 March 2020 to check if they are eligible for a free correction to their ARTG entry.

This guidance only applies to medicines listed under section 26A of the Therapeutic Goods Act 1989 ('the Act') and does not apply to Export Only medicines.

Sponsors of existing listed medicines

Sponsors of existing listed medicines containing propolis and royal jelly should review their ARTG entries and determine if their ARTG entry needs to be corrected. Not all listed medicines will need to change.

Sponsors of existing medicines who believe that propolis or royal jelly preparations have been entered incorrectly due to this system limitation can make a request for their ARTG entry to be corrected via email at Complementary.Medicines@health.gov.au.

Please provide the following:

  • ARTG number
  • Product name
  • Active: [e.g. Propolis 500 mg etc.]
  • Equivalent: [e.g. Propolis dry extract 100 mg]

The TGA will update the parent ingredient and the equivalent ingredient on your behalf. An application fee will not apply to this change. You do not need to make an application through the online form; however, we will not make any other changes to your entry at this time.

If you do not advise us before 31 March 2020, you will need to apply through the normal process for a paid section 9D(1) variation. For more information, see the Application and submission user guide for listed medicines.

If you determine that your ARTG entries are correct, you do not need to do anything further.

As this is just a correction to the ARTG, we are not anticipating that this change will require changes to product labels or manufacturing documents.

Sponsors of new medicines

Sponsors will be able to enter preparations with the quantity of equivalent starting material in a way that accurately reflects the active ingredient contained in their medicine. It is the sponsor's responsibility to ensure that the information entered into the ARTG entry is correct.

Background

Due to limitations in the listed medicines application system ('ELF'), applicants could not enter an equivalent quantity of propolis or royal jelly that was greater than the parent ingredient quantity for of the propolis or royal jelly. As a result, sponsors were required to enter information about propolis or royal jelly preparations into the ARTG entry in a way that may not reflect the true active ingredient.

In order to enable sponsors to declare the equivalent quantity of the starting material for concentrated ABN preparations, the TGA advised sponsors that the accepted way to enter ingredient information for propolis and royal jelly ingredients was to enter the fresh equivalent as the Active ingredient and then declare the extracted substance as the Component. Residual solvents from this extraction were to be declared as excipients in the formulation.

As an example, when a listed medicine contains 100mg of a 5:1 propolis liquid extract concentrate with 10% residual ethanol, previously the sponsor had to enter this into the ARTG entry as:

Active: Propolis 500 mg
Equivalent: Propolis liquid extract 100 mg
Excipient: Ethanol 10 mg

This caused confusion for sponsors and consumers when comparing a medicine label with information on the ARTG entry.

Following enhancements to the listed medicine application system, sponsors can now enter propolis and royal jelly preparations ingredients as the parent active ingredient and declare an equivalent quantity of the starting material where the equivalent quantity is greater than the parent ingredient.

Sponsors will now be able to enter this ingredient as follows:

Active: Propolis liquid extract 100 mg
Equivalent: Propolis 500 mg
Excipient: Ethanol 10 mg

Any residual solvents will still need to be entered separately as standard excipients.

The Permissible Ingredient Determination sets out a list of ingredients that can be used in listed medicines and any requirements relating to their use.

The Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019 which was in force at the time of this publication lists the following ingredients as available for use in listed medicines.

See the latest Permissible Ingredients Determination as this information can change.

Ingredient name Purpose Specific requirements
PROPOLIS Active or Excipient

Lead is a mandatory component of Propolis.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label:

  • (PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

  • (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
PROPOLIS BALSAM Active or Excipient

Lead is a mandatory component of Propolis balsam.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label:

  • (PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

  • (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
PROPOLIS DRY EXTRACT Active or Excipient

Lead is a mandatory component of Propolis dry extract.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label

  • (PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

  • (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
PROPOLIS LIQUID EXTRACT Active or Excipient

Lead is a mandatory component of Propolis liquid extract.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label:

  • (PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

  • (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
PROPOLIS RESIN Active or Excipient

Lead is a mandatory component of propolis resin.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label:

  • (PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

  • (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
PROPOLIS TINCTURE Active or Excipient

Lead is a mandatory component of Propolis tincture.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label:

  • (PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

  • (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
ROYAL JELLY Active or Excipient

10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly.

The medicine requires the following warning statements on the medicine label:

  • (CHILD2) 'Not suitable for children'
  • (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.
ROYAL JELLY FRESH Active or Excipient

10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly fresh.

The medicine requires the following warning statements on the medicine label:

  • (CHILD2) 'Not suitable for children'
  • (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.
ROYAL JELLY LYOPHILISED Active or Excipient

10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly lyophilised.

The medicine requires the following warning statements on the medicine label:

  • (CHILD2) 'Not suitable for children'
  • (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.

Further assistance

If you believe there is further information that needs updating on your ARTG entry, you will need to make a separate application through the online listed medicines application form. Please see the Application and submission user guide for help using the online form and the Guidance on product changes for help identifying the application type and fee.

If you need to make other changes to your ARTG entry, you will need to either:

  1. wait until after we have completed your correction to propolis/royal jelly on your ARTG entry and the change appears in your draft application.
  2. complete the variation application before you request us to make the correction.

If you try doing both at the same time, it will create problems with your ARTG entry.

Contact us at 02 6289 4627 or Complementary.Medicines@health.gov.au.

If you are not sure which of your products may be affected, please contact us and we can assist you to identify your affected medicines. However, it is your responsibility to tell us which is the correct active and equivalent ingredients.


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