This consultation closed on 11 October 2019.
On this page: Proposed changes to the Permissible Ingredients Determination - low-negligible risk | Timetable | Proposed low-negligible risk changes | What will happen | Privacy and your personal information | Enquiries
Proposed changes to the Permissible Ingredients Determination - low-negligible risk
The Therapeutic Goods (Permissible Ingredients) Determination ('the Determination') is a legislative instrument under section 26BB of the Therapeutic Goods Act 1989. This instrument specifies all of the ingredients that are available for use in listed and assessed listed medicines and their associated requirements. The Determination is continually reviewed by the TGA to ensure that all ingredients and their requirements are appropriate for use in low-risk medicines.
The proposed ingredient changes in this consultation have been reviewed and categorised as being of low-negligible risk. The purpose of this consultation is to provide an opportunity for consumers, health professionals, industry and other interested parties to comment on these proposed changes which are due to commence on 2 March 2020 (see schedule for low-negligible risk changes for 2019-2020). Interested parties may provide submissions which address any, or all, of the proposed changes in the consultation document or other identified issues.
Timetable
Interested parties should respond by close of business 11 October 2019.
The TGA will publish notification of the final determinations from these considerations by 2 December 2019 (see What will happen).
Proposed low-negligible risk changes
Boron
Boron containing compounds are found in a number of pharmaceutical products and used in listed medicines mainly in oral and topical medicines. Boron containing compounds are used as antimicrobial preservatives, buffering agents to control the pH and as tonicity-adjusting agents. They are also used as active ingredients, mostly for mineral supplementation.
Commonly used boron-containing compounds include boric acid, salts of boric acid such as borax (also known as sodium borate), and other borates (i.e. boron-containing oxyanions). Sponsors who include boron in listed medicines from these ingredients must declare the content of boron used within their listed medicine applications.
Recently, the European Medicines Agency[1] ('EMA') have found evidence linking boron exposure to the increased risk of infertility and established safe limits of boron exposure, dependant on age group. The EMA also considered it necessary to include appropriate information on boron-containing medicines so that consumers can be well-informed of the potential impacts these medications may have on sensitive populations i.e. pregnant women and children. The TGA proposes that listed medicines that contain boron exceeding the EMA limits should require warning statements to ensure safer and appropriate use of listed medicines.
Background
The EMA has identified that boron exposure can cause infertility later in life. EMA's review found that animal toxicity studies showed reduced fertility or complete sterility in rats, as well as teratogenic and fetotoxic effects. Human data is limited. Based on these studies, the EMA have established the following amounts of boron per age group in humans which may impair fertility if exceeded:
- <2 years - 1 mg boron/day
- <12 years - 3 mg boron/day
- <18 years - 7 mg boron/day
- ≥18 years - 10 mg boron/day
In addition, the maximum recommended daily dose of a listed medicine must not provide more than 6 mg of boron due to scheduling within the Poisons Standard. The schedule 5 entry for boron-related substances such as boric acid aims to align with European Union ('EU') concentrations for cosmetics and to also ensure that persons using boron-containing products have adequate information to determine legitimate safe use of boric acid and related products.[2]
During the 20th meeting of the Advisory Committee on Complementary Medicines ('ACCM'), the committee discussed and advised the TGA that warning statements in line with the EMA review were appropriate for listed medicines containing boron. The committee acknowledged the potential of systemic absorption associated with the use of topical preparations on broken, inflamed or irritated skin and therefore considers a warning statement for topical preparations is warranted. This was similarly considered within joint meetings of the Advisory Committee on Chemicals and Medicines Scheduling regarding labelling of cosmetic products containing boric acid with "NOT TO BE USED ON PEELING OR IRRITATED SKIN". The ACCM also advised the TGA that warning statements are warranted to appropriately inform consumers to minimize the risk of systemic boron absorption in children depending on the amount of boron provided in the medicine.
Please note the current requirements for boron were a reflection of the Poisons Standard prior to a recent interim decision to amend the Poisons Standard (to be implemented on 1 February 2020). These requirements will be reviewed for accuracy separate to this consultation.
Proposal
The TGA proposes to update the current requirements for boron containing medicines in line with the EMA requirements. Sponsors of boron-containing medicines will need to label listed medicines containing boron to caution use in children under the age of 2 or 12 (depending on the dose of boron). In line with ACCM advice and recent proposal to change the Poisons Standard for cosmetic products, the TGA proposes that a label statement is required on boron-containing medicines to warn consumers not to use these products on broken skin. Sponsors of existing boron-containing medicines will have until the end of the transition period to amend the specific ingredient requirements as shown below.
Change to the Therapeutic Goods (Permissible Ingredients) Determination
| Ingredient name | Purpose | Existing specific requirements | Proposed specific requirements |
|---|---|---|---|
| BORAX | A, E, H | Boron is a mandatory component of Borax. The percentage of Boron from Borax should be calculated based on the molecular weight of Borax. The maximum recommended daily dose must provide no more than 6mg of Boron. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of Boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%. | Boron is a mandatory component of Borax. The percentage of Boron from Borax should be calculated based on the molecular weight of Borax. The maximum recommended daily dose must provide no more than 6mg of Boron. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of Boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%. When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:
When the maximum recommended daily dose of the medicine provides more than 1 mg of boron but less than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:
When the medicine is for topical use for dermal application, the following warning statement is required on the label:
|
| BORAX PENTAHYDRATE | A, E | Boron is a mandatory component of Borax Pentahydrate. The percentage of Boron from Borax pentahydrate should be calculated based on the molecular weight of Borax Pentahydrate. The maximum recommended daily dose must provide no more than 6mg of Boron from Borax pentahydrate. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 g/L or 0.35%. | Boron is a mandatory component of Borax Pentahydrate. The percentage of Boron from Borax pentahydrate should be calculated based on the molecular weight of Borax Pentahydrate. The maximum recommended daily dose must provide no more than 6mg of Boron from Borax pentahydrate. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 g/L or 0.35%. When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:
When the maximum recommended daily dose of the medicine provides more than 1 mg of boron but less than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:
When the medicine is for topical use for dermal application, the following warning statement is required on the label:
|
| BORIC ACID | A, H | Boron is a mandatory component of Boric acid. The percentage of Boron from Boric acid should be calculated based on the molecular weight of Boric acid. The maximum recommended daily dose must provide no more than 6mg of Boron. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%. | Boron is a mandatory component of Boric acid. The percentage of Boron from Boric acid should be calculated based on the molecular weight of Boric acid. The maximum recommended daily dose must provide no more than 6mg of Boron. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%. When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:
When the maximum recommended daily dose of the medicine provides more than 1 mg of boron but less than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:
When the medicine is for topical use for dermal application, the following warning statement is required on the label:
|
| SODIUM PERBORATE | A, H | Boron is a mandatory component of sodium perborate. When for internal use, the maximum recommended daily dose must not provide more than 6 mg of boron. When used preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron from all ingredients in the product must not exceed 3500 mg/kg or 3500 mg/L or 0.35%. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:
| Boron is a mandatory component of sodium perborate. When for internal use, the maximum recommended daily dose must not provide more than 6 mg of boron. When used preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron from all ingredients in the product must not exceed 3500 mg/kg or 3500 mg/L or 0.35%. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:
When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:
When the maximum recommended daily dose of the medicine provides more than 1 mg of boron but less than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:
When the medicine is for topical use for dermal application, the following warning statement is required on the label:
|
Impact on existing listed medicines
A search of the ARTG on 17 June 2019 indicates there were 196 listed medicines that contain the ingredients specified in the proposed change. Of these medicines, 184 are for internal use and/or oral application and 12 are for a topical route of administration.
References
| [1] | European Medicines Agency. (2017). Questions and answers on boric acid and borates used as excipients in medicinal products for human use. (EMA/CHMP/619104/2013). London UK: European Union Retrieved from https://www.ema.europa.eu/en/boric-acid-borates |
|---|---|
| [2] | Therapeutic Goods Administration. (2019, 07/03/2019). Publication of interim decisions amending, or not amending, the current Poisons Standard, February 2019. Retrieved from https://www.tga.gov.au/scheduling-decision-interim/publication-interim-decisions-amending-or-not-amending-current-poisons-standard-february-2019 |
Withania somnifera
Withania somnifera, known in Ayurveda as 'Ashwaghanda', is a plant that has been used in traditional medicines and is currently permitted for use in listed medicines as an active, excipient or homeopathic ingredient without specific requirements. Traditional and anecdotal evidence indicates that Withania somnifera has been used to benefit pregnancy and, in alternative paradigms, to induce abortion. As a result of this, World Health Organization ('WHO') and Health Canada include safety concerns regarding pregnancy and the use of Withania somnifera. The TGA proposes that a similar warning label statement is appropriate for listed medicines containing Withania somnifera.
Background
There is conflicting anecdotal evidence in some traditional medicine paradigms that report Withania somnifera is used to support pregnancy and lactation or used as an emmenagogue (stimulates or increases menstrual flow) and/or as an abortifacient. The Health Canada monograph for Ashwagandha and WHO monographs on selected medicinal plants[1] caution against use of the herb during pregnancy and breastfeeding.
The TGA identified seven publications[2-8] relating to traditional use of Withania somnifera. Two (2) of these publications report abortifacient properties for Withania somnifera. Al-Qura'n[2] interviewed 80 informants from southern Jordan and reports 17 informants' specified abortion and sterility as toxic effects of Withania somnifera. Sahu[7] published the results of their survey in Madhya Pradesh, India which reports the 'root is very efficacious for toning up the ulcerus [sic] of women who habitually miscarry and is used for easy abortion', but does not specify the number of informants for these claims.
The remaining 5 publications suggest Withania somnifera can be used to aid conception, pregnancy or lactation, to treat gynaecological problems such as infertility[3], [6], sexual illness[4] and to reduce menstrual cycle irregularities[5], [8].
The publications did not provide detail which would allow assessment of whether the preparation method of the plant was a factor in the differing effects reported.
The contradictory uses of Withania somnifera were presented at the 21st meeting of the Advisory Committee on Complementary Medicines ('ACCM') and the committee advised that the available anecdotal and clinical evidence is insufficient to establish that Withania somnifera is safe in pregnancy or as an abortifacient. The committee also noted that the Health Canada monograph requires label warning statements advising consultation with a health care professional during pregnancy or when breastfeeding and advised that similar warning statements are appropriate for listed medicines containing Withania somnifera.
Proposal
In line with ACCM advice, the TGA proposes to introduce warning statements for medicines containing Withania somnifera advising consumers to consult a health care professional if they are pregnant or breastfeeding. Sponsors of existing medicines containing Withania somnifera will have until the end of the transition period to amend the specific ingredient requirements as shown below.
Change to the Therapeutic Goods (Permissible Ingredients) Determination
| Ingredient name | Purpose | Existing specific requirements | Proposed specific requirements |
|---|---|---|---|
| WITHANIA SOMNIFERA | A, E, H | The medicine requires the following warning statement on the label:
|
Impact on existing listed medicines
A search of the ARTG on 17 June 2019 indicates there were 172 listed medicines which contain Withania somnifera as an active ingredient intended for oral use.
References
| [1] | World Health Organization. (2009). Who Monographs on Selected Medicinal Plants. In WHO Consultation on Selected Medicinal Plants, Vol. 4. (pp. 388). Retrieved from https://www.medbox.org/traditional-treatment/who-monographs-on-selected-medicinal-plants-volume-4/preview |
|---|---|
| [2] | Al-Qura'n, S. (2005). Ethnobotanical survey of folk toxic plants in southern part of Jordan. Toxicon, 46(2), 119-129. doi:https://doi.org/10.1016/j.toxicon.2005.04.010 |
| [3] | Aziz, M. A., Khan, A. H., Ullah, H., Adnan, M., Hashem, A., & Abd_Allah, E. F. (2018). Traditional phytomedicines for gynecological problems used by tribal communities of Mohmand Agency near the Pak-Afghan border area. Revista Brasileira de Farmacognosia, 28(4), 503-511. doi:https://doi.org/10.1016/j.bjp.2018.05.003 |
| [4] | Mahmood, A., Mahmood, A., Malik, R. N., & Shinwari, Z. K. (2013). Indigenous knowledge of medicinal plants from Gujranwala district, Pakistan. Journal of Ethnopharmacology, 148(2), 714-723. doi:https://doi.org/10.1016/j.jep.2013.05.035 |
| [5] | Mishra, D., Singh, R., Srivastava, R. K., & Dubey, S. R. (2013). Ethnomedicinal plants used to cure the gynaecological disorders by ethnic populace of Sitapur district, Uttar Pradesh, India. Medicinal Plants - International Journal of Phytomedicines and Related Industries, 5, 238. doi:10.5958/j.0975-6892.5.4.038 |
| [6] | Moteetee, A., & Seleteng Kose, L. (2016). Medicinal plants used in Lesotho for treatment of reproductive and post reproductive problems. Journal of Ethnopharmacology, 194, 827-849. doi:https://doi.org/10.1016/j.jep.2016.10.062 |
| [7] | Sahu, T. R. (1982). An ethnobotanical study of madhya pradesh 1: plants used against various disorders among tribal women. Ancient science of life, 1(3), 178-181. |
| [8] | Wadankar, G. D., Malode, S., & Sarambekar, S. L. (2011). Indigenous Medicine Used for Treatment of Gynecological and other related Problems in Washim District, Maharashtra. International Journal of PharmTech Research, 3, 698-701. |
Vitex agnus-castus
Vitex agnus-castus is also known as Chaste Tree, Chasteberry and Monk's Pepper. The plant has a traditional use as a tonic for both male and female reproductive systems and is marketed for menstrual disorders, including symptoms of premenstrual syndrome and/or menopause, as well as for acne. It is currently permitted for use in listed medicines as an active, excipient or homeopathic ingredient without specific requirements. The TGA has considered evidence that indicates is an interaction between Vitex agnus-castus in combination with medications affecting hormones such as oral contraceptives. Several international health authorities have also released publications which highlight safety concerns of Vitex agnus-castus in combination with hormone-related medication.
Background
The TGA recently published a safety advisory on the potential for a Vitex agnus-castus interaction with oral contraceptives following a report of unintended pregnancy. The Health Canada monograph for Vitex agnus-castus[1] advises warning statements to consult a health care professional prior to using Vitex agnus-castus if taking hormone-containing medications. A similar warning for Vitex agnus-castus containing medicines is also stated by the European Medicines Agency[2]. Additionally, WHO[3]and the United States Food and Drug Agency[4] identified possible interactions between hormone-related medications and conditions with Vitex agnus-castus. The WHO monograph for Fructus Agni Casti (dried Vitex agnus-castus fruit) highlights the interaction of Vitex agnus-castus with medications such as dopaminergic-receptor antagonists.
Vitex agnus-castus has been known to effect menstrual cycle irregularities as well as infertility and premenstrual syndrome[5]. The impact of Vitex agnus-castus on estrogen and progesterone metabolism is also scientifically recognised[6].
Since Vitex agnus-castus is presented as a premenstrual syndrome remedy, there is a strong likelihood that it will be taken in combination with hormone-related medications. Before concurrent consumption of such medicines with Vitex agnus-castus, the advice of a health care professional would be necessary to consider the impacts of this interaction.
Proposal
The TGA proposed to require a label warning statement which identifies potential interactions between formulations containing Vitex agnus-castus and other medicines, particularly the oral contraceptive pill. Sponsors of existing medicines containing Vitex agnus-castus will have until the end of the transition period to amend the specific ingredient requirements as shown below.
Change to the Therapeutic Goods (Permissible Ingredients) Determination
| Ingredient name | Purpose | Existing specific requirements | Proposed specific requirements |
|---|---|---|---|
| VITEX AGNUS-CASTUS | A, E, H | When for internal use, the medicine requires the following warning statement on the label:
|
Impact on existing listed medicines
A search of the ARTG on the 17 June 2019 indicates there were 77 listed medicines which contain Vitex agnus-castus that are intended for internal administration. All of these medicines are for an oral route of administration and contain Vitex agnus-castus as the active ingredient.
References
| [1] | Health Canada. (2018, 03/06/2019). Chaste Tree - Vitex Agnus-Castus. Retrieved from http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=chaste.tree.vitex&lang=eng |
|---|---|
| [2] | European Medicines Agency. (2017). Final European Union herbal monograph on Vitex agnus-castus L., fructus. (EMA/HMPC/606742/2017). London UK: European Union Retrieved from https://www.ema.europa.eu/en/medicines/herbal/agni-casti-fructus |
| [3] | World Health Organization. (2009). Who Monographs on Selected Medicinal Plants. In WHO Consultation on Selected Medicinal Plants, Vol. 4. (pp. 24). Retrieved from https://www.medbox.org/traditional-treatment/who-monographs-on-selected-medicinal-plants-volume-4/preview |
| [4] | National Center for Complementary and Integrative Health. (2016, 29/11/2016). Chasteberry. Retrieved from https://nccih.nih.gov/health/chasteberry |
| [5] | Bone, K., & Mills, S. (2005). The Essential Guide to Herbal Safety (First ed.). (pp. 333-336) Edinburgh: Elsevier Churchill Livingstone. |
| [6] | Liu, J., Burdette, J. E., Xu, H., Gu, C., van Breemen, R. B., Bhat, K. P. L., Booth, N., Constantinou, A. I., Pezzuto, J. M., Fong, H. H. S., Farnsworth, N. R., Bolton, J. L. (2001). Evaluation of Estrogenic Activity of Plant Extracts for the Potential Treatment of Menopausal Symptoms. Journal of Agricultural and Food Chemistry, 49(5), 2472-2479. doi:10.1021/jf0014157 |
Hydroxyisohexyl-3-cyclohexene carboxaldehyde ('HICC')
Hydroxyisohexyl-3-cyclohexene carboxaldehyde, ('HICC'), is a synthetic fragrance chemical that contains a mixture of isomers. HICC is currently used within a number of listed medicines in proprietary fragrance formulations, including sunscreens. The National Industrial Chemicals Notification and Assessment Scheme[1] and the Scientific Committee on Consumer Safety ('SCCS')[2] of the European Commission have considered that the ingredient is an established skin sensitiser and common contact allergen, and is unsuitable for cosmetic goods. Under European Union Regulations, the ingredient should be removed from cosmetic products by 23 August 2021. The TGA suggest that existing availability of HICC as an ingredient within fragrance formulations is inappropriate, and the ingredient should be removed from the Determination.
Background
HICC is a synthetic 70:30 mixture of two chemicals, 4-(4-hydroxy-4-methylpentyl)-3-cyclohexene carboxaldehyde (CAS No. 31906-04-4) and 4-(4-hydroxy-4-methylpentyl)-3-cyclohexene carboxaldehyde (CAS No. 51414-25-6) and is used as an ingredient used within fragrance proprietary ingredients of listed medicines. A review of the scientific literature shows that HICC has been reported as a contact allergen[2].
The European Union[3] has mandated the exclusion of HICC in cosmetic products of any form from 23 August 2021. The removal of HICC from cosmetics was based on a report[2] by the SCCS which details documented cases related to HICC induced allergy since 1999. To prevent contact allergy and limit consequences to individuals who have already become sensitised, the SCCS have advised that HICC should not be used in consumer products.
Proposal
The TGA proposes that HICC will be removed from the Determination as it is not suitable as an ingredient for use in listed medicines. New products which contain HICC will not be available for listing in the Register. Sponsors of existing listed medicines will have until the end of the transition period to remove the ingredient from their medicines.
Change to the Therapeutic Goods (Permissible Ingredients) Determination
Note
Deleted text is shown as red, smaller font, with a strikethrough.
| Ingredient name | Purpose | Existing specific requirements | Proposed specific requirements |
|---|---|---|---|
| Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
|
Impact on existing listed medicines
A search of the ARTG on 12 June 2019 indicates there were 58 listed medicines that contain '4-(4-hydroxy-4-methylpentyl)-3-cyclohexene carboxaldehyde' as an ingredient of a proprietary fragrance formulation.
References
| [1] | National Industrial Chemicals Notification and Assessment Scheme. (2018, 26/10/2018). HICC: Human health tier II assessment. IMAP Group Assessment Report. Retrieved from https://www.nicnas.gov.au/chemical-information/imap-assessments/imap-group-assessment-report?assessment_id=13315 |
|---|---|
| [2] | Scientific Committee on Consumer Safety. (2011). Opinion on Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC) (SCCS/1456/11 ). (pp. 102) Brussels, Belgium European Commission Retrieved from https://ec.europa.eu/health/scientific_committees/consumer_safety/sccs_09-13/opinions_en |
| [3] | European Commission. (2017). Commission Regulation (EU) 2017/1410 of 2 August 2017 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. (L 202/1). European Commission Retrieved from https://ec.europa.eu/growth/sectors/cosmetics/legislation_en |
Minor changes
The following proposed changes are of a minor nature and clarify the existing requirements for use in listed medicines. Amended text is highlighted in red.
Change to the Therapeutic Goods (Permissible Ingredients) Determination
Note
New text is shown as green, larger font, with a horizontal line above it.
Deleted text is shown as red, smaller font, with a strikethrough.
| Ingredient name | Proposed change | Justification |
| ISPAGHULA HUSK DRY | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| ISPAGHULA HUSK POWDER | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| PLANTAGO AFRA | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| PLANTAGO ARENARIA | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| PLANTAGO ASIATICA | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| PLANTAGO LANCEOLATA | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| PLANTAGO MAJOR | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| PLANTAGO OVATA | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| PLANTAGO SEED DRY | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| PSYLLIUM HUSK DRY | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| PSYLLIUM HUSK POWDER | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| PSYLLIUM SEED DRY | When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
| Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium. |
| CYMBOPOGON FLEXUOSUS | Aldehydes calculated as citral is a mandatory component of Cymbopogon flexuosus. The concentration | Alignment with the Poisons Standard June 2019 |
| CYMBOPOGON MARTINI | Aldehydes calculated as citral is a mandatory component of Cymbopogon Martini. The concentration | Alignment with the Poisons Standard June 2019 |
| CYMBOPOGON NARDUS | Aldehydes calculated as citral is a mandatory component of Cymbopogon Nardus. The concentration | Alignment with the Poisons Standard June 2019 |
| CYMBOPOGON SCHOENANTHUS | Aldehydes calculated as citral is a mandatory component of Cymbopogon schoenanthus. The concentration | Alignment with the Poisons Standard June 2019 |
| MALUS PUMILA | Ingredient to be removed from the Determination | Synonym for MALUS DOMESTICA. Sponsors may request TGA to amend existing listed medicines within the transition period. |
What will happen
Public submissions may be published on the TGA website at Changes to the Permissible Ingredients Determination, unless marked confidential or indicated otherwise in the submission cover sheet.
Following consideration of public submissions received before the closing date and advice from relevant expert advisory committees, decisions on the proposed change will be published as interim decisions on the TGA website Changes to the Permissible Ingredients Determination by 2 December 2019.
Privacy and your personal information
Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
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Enquiries
Any questions relating to submissions should be directed by email to complementary.medicines@health.gov.au.