Section 19A medicines subsidised by the Pharmaceutical Benefits Scheme
Page last updated: 1 April 2024
In the event of a medicine shortage, a provision under section 19A of the Therapeutic Goods Act 1989 allows for temporary approvals to be granted for the import or supply of a brand of medicine that is not registered on the Australian Register of Therapeutic Goods, which could act as a substitute for the medicine that is unavailable or in short supply. A list of section 19A medicines approved for supply are available on the TGA website.
Where possible, the Australian Government works with medicine sponsors to organise PBS subsidised access to section 19A medicines.
Provided below is a list of section 19A medicines currently subsidised by the Pharmaceutical Benefits Scheme (PBS).
Applying for PBS listing of section 19A product
If the brand, drug, form, manner of administration and responsible person of the section 19A medicine are all the same as the PBS listed product in short supply, then the section 19A medicine is a ‘pharmaceutical benefit’ as defined in the National Health Act 1953, and may be subsidised under the existing PBS listing. The responsible person of a section 19A medicine must be the sponsor for whom the TGA approval is granted. Please note that the list below does not include section 19A medicines that are subsidised in this way and have not been considered by the Pharmaceutical Benefits Advisory Committee.
Where the brand, drug, form, manner of administration and responsible person of the section 19A medicine are not all the same as the PBS listing in short supply, sponsors need to submit an application in writing to PBS Pricing (PBSpricing@health.gov.au) and PBAC (PBAC@health.gov.au) to list the item on the PBS.
Application should consist of the PBS forms:
- Part C of the Application Form for Submission Services
- PB11 – Application to list
- PB11a – Request for Approved Ex-manufacturer Price
- PB11b – Cost of goods information
- Notification of Responsible Person Form
- Copy of TGA section 19A approval
- Copy of Product Information sheet
There are no cost recovery fees associated with the temporary listing of a section 19A item.
In addition to listing section 19A medicines to manage medicine shortages, the Department also works to implement PBS subsidy arrangements for TGA issued Serious Scarcity Substitution Instruments. Further information is available at PBS subsidy arrangements for medicines subject to a Serious Scarcity Substitution Instrument.
|
Section 19A medicine |
Section 19A Responsible person |
TGA Section 19A approval |
Date PBS listed |
Notes |
|---|---|---|---|---|
|
Ethosuximide Essential Generics (UK) |
Clinect Pty Ltd |
1 April 2024 |
||
|
Oral solution containing hydromorphone hydrochloride 1 mg per mL, 1 mL (S19A) (Pharmascience) |
Medsurge Healthcare Pty Ltd |
PMS-HYDROMORPHONE hydromorphone hydrochloride 1 mg/mL oral syrup (Pharmascience) |
1 March 2024 |
This product is NOT a-flagged to Hikma or Hydromorphone hydrochloride oral solution, USP (Medsurge) |
|
Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (S19A) |
Medsurge Healthcare Pty Ltd |
MORPHINI HCL STREULI morphine hydrochloride 10mg/mL oral drops (Switzerland) |
1 March 2024 |
This product is a-flagged to Ordine 10 in the Schedule for General and Palliative Care listings. |
|
Fluoxetine Capsules 10 mg (Medreich, UK) Capsule 10 mg (Medreich) (S19A) |
Link Medical Products Pty Ltd |
01 February 2024 |
This product is not a-flagged to Zactin Tablet |
|
|
Sachet containing 4 g oral powder (S19A) |
Medsurge Healthcare Pty Ltd |
01 February 2024 |
This product is not a-flagged to Questran Lite |
|
|
Nebuliser solution 2.5 mg (as sulfate) in 2.5mL single dose units, 20 (S19A) |
Medsurge Healthcare Pty Ltd |
PMS-SALBUTAMOL salbutamol sulphate inhalation solution, BP 1mg/1mL (2.5mg/2.5mL) (Canada)
|
01 February 2024 |
|
|
Benzylpenicillin Benzathine (Brancaster Pharma, UK) Benzathine benzylpenicillin Powder for injection 1,200,000 units with diluent 5 mL (S19A) |
ORSPEC Pharma Pty Ltd |
01 January 2024 |
||
|
Adefovir Dipivoxil Tablets 10 mg (SigmaPharm Laboratories) Adefovir, Tablet containing adefovir dipivoxil 10 mg (S19A) |
Arrotex Pharmaceuticals Pty Ltd |
01 December 2023 |
||
|
Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL Morphine, Oral solution containing morphine sulfate 10 mg per 5 mL in 100 mL bottle, 1 mL (S19A) |
Link Medical Products Pty Ltd |
Morphine sulfate 10 mg/5 mL oral solution (Martindale Pharma) |
01 December 2023 |
This product is a-flagged to Ordine 2 in the Schedule for General listings. There is no a-flagging for Palliative Care listing. |
|
Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL Morphine, Oral solution containing morphine sulfate 10 mg per 5 mL in 300 mL bottle, 1 mL (S19A) |
Link Medical Products Pty Ltd |
Morphine sulfate 10 mg/5 mL oral solution (Martindale Pharma) |
01 December 2023 |
This product is a-flagged to Ordine 2 in the Schedule for General listings. There is no a-flagging for Palliative Care listing. |
|
Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL) Morphine, Oral solution containing morphine sulfate 2 mg per mL in 100 mL bottle, 1 mL (S19A) |
Medsurge Healthcare Pty Ltd |
01 December 2023 |
This product is a-flagged to Ordine 2 in the Schedule for General listings. There is no a-flagging for Palliative Care listing. |
|
|
Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL) Morphine, Oral solution containing morphine sulfate 2 mg per mL in 500 mL bottle, 1 mL (S19A) |
Medsurge Healthcare Pty Ltd |
01 December 2023 |
This product is a-flagged to Ordine 2 in the Schedule for General listings. There is no a-flagging for Palliative Care listing. |
|
|
Amoxicillin with clavulanic acid Amoxicillin with clavulanic acid, powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 50 mL (S19A) |
Medsurge Healthcare Pty Ltd |
Amoxicillin and clavulanate potassium for oral suspension, USP 400mg/57mg per 5mL (Aurobindo) |
01 November 2023 |
|
|
Methylprednisolone, powder for injection 40 mg (as sodium succinate) (S19A) |
Link Medical Products Pty Ltd |
Solu-Medrone methylprednisolone sodium succinate 40mg powder for injection (Pfizer, UK) |
01 November 2023 |
|
|
Cefuroxime Powder for oral suspension 125 mg (as axetil) per 5 mL, 70 mL (S19A) |
Reach Pharmaceuticals Pty Ltd |
ZINNAT Cefuroxime axetil 125 mg/5 mL granules for oral suspension (UK) |
01 October 2023 |
This product is not a-flagged to Zinnat |
|
Glucagon hydrochloride Injection set containing glucagon hydrochloride 1 mg (1 I.U.) and 1 mL solvent in disposable syringe (s19A) |
Medsurge Healthcare Pty Ltd |
GlucaGen HypoKit glucagon 1mg powder and solvent for solution for injection (Germany) |
01 September 2023 |
|
|
Naxalone Nasal Spray 1.8 mg (as hydrochloride dihydrate) in 0.1 ml single dose unit, 2 (s19A) |
Pro Pharmaceuticals Group Pty Ltd |
NYXOID naloxone 1.8mg nasal spray solution in a single-dose container (UK) |
01 September 2023 |
|
|
Tablet 0.5 mg (as tartrate) (s19A) |
Arrotex Pharmaceuticals Pty Ltd |
1 August 2023 |
This product not a-flagged to Champix. |
|
|
Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo – Pro Pharmaceuticals) Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A) |
Pro Pharmaceuticals Group Pty. Ltd |
Amoxicillin and clavulanate potassium tablets, USP 875mg/125mg (Aurobindo) |
1 June 2023 |
|
|
Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Micro Labs) Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A) |
Pro Pharmaceuticals Group Pty. Ltd |
Amoxicillin and clavulanate potassium tablets, USP 875mg/125mg (Micro Labs) |
1 June 2023 |
|
|
Powder for oral liquid containing cefalexin 250mg/5 mL (s19A) |
Pro Pharmaceuticals Group Pty Ltd |
KEFORAL cefalexin 250mg/5ml granules for oral suspension (Italy) |
1 June 2023 |
|
|
Capsule containing disopyramide 100 mg (s19A) |
ORSPEC Pharma Pty Ltd |
1 June 2023 |
|
|
|
Minoxidil 10 mg (Roma Pharmaceuticals) Tablet containing minoxidil 10 mg (s19A) |
ORSPEC Pharma Pty Ltd |
1 June 2023 |
|
|
|
Powder for oral solution phenoxymethylpenicillin 250mg/5 mL (s19A) |
Pro Pharmaceuticals Group Pty Ltd |
PENOPEN phenoxymethylpenicillin 250mg/5ml powder for oral solution (Cyprus) |
1 June 2023 |
|
|
Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A) |
Medsurge Healthcare Pty Ltd |
Amoxicillin and clavulanate potassium tablets, USP 875mg/125mg (Aurobindo) |
1 December 2022 |
|
|
Tablet 15 mg (as sulfate) s19A |
Medsurge Healthcare Pty Ltd |
1 November 2022 |
||
|
Powder for injection 50 mg with solvent (s19A) |
Pro Pharmaceuticals Groups Pty. Ltd. |
1 October 2022 |
||
|
Tablet containing imipramine hydrochloride 25 mg (s19A), |
Pro Pharmaceuticals Group Pty. Ltd. |
Imipramine Hydrochloride Tablets, USP, 25mg 100 tablets (Leading Pharma, LLC) |
1 July 2022 |
|
|
Arrowtex Pharmaceuticals Pty Ltd |
1 May 2022 |
Supply Only (SO) from 1 January 2024 until 1 July 2024 (6 months) |
||
|
Mycobacterium bovis (Bacillus Calmette and Guerin (BCG)) Danish 1331 strain Single dose pack containing powder for irrigation 30 mg, 4 vials |
Link Medical Products Pty Ltd |
|
1 April 2022 |
|
|
Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 (s19A) |
Medsurge Healthcare Pty Ltd |
1 March 2022 |
|
|
|
Powder for injection 5,000 units with solvent (s19A) |
Medsurge Healthcare Pty Ltd |
1 March 2022 |
|
|
|
Oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 mL |
Link Medical Products Pty Ltd |
HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION 1mg/mL USP 473mL (West-Ward) |
1 December 2021 |
A-flagged to s19A medicine HYDROmorphone Hydrochloride 1mg/mL oral solution, USP 473mL (Rhodes) and NOT a-flagged to Dilaudid. |
|
Hydromorphone, oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 mL |
Medsurge Healthcare Pty Ltd |
HYDROmorphone Hydrochloride 1mg/mL oral solution, USP 473mL (Rhodes) |
1 July 2021 |
This product is not a-flagged to Dilaudid. |
|
Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL, USP (Apotex) |
Medsurge Healthcare Pty Ltd |
1 June 2021 |
|
|
|
Injection containing naloxone hydrochloride 2 mg in 2 mL pre-filled syringe |
Phebra Pty Ltd |
PRENOXAD 1mg/mL Solution for Injection in a pre-filled syringe (naloxone hydrochloride) |
1 April 2017 |
|
|
Capsule 3 mg |
Boucher & Muir Pty Ltd |
1 October 2017 |
|
|
|
Oral liquid 50 mg per mL, 100 mL |
Pfizer Australia Pty Ltd |
1 August 2018 |
|
|
|
Phenoxybenzamine, capsules containing phenoxybenzamine hydrochloride 10 mg, 30 |
Amdipharm Mercury (Australia) Pty Limited |
1 March 2016 |
||
|
Injection set containing 550 micrograms with diluent |
Stallergenes Australia Pty Ltd |
Hymenoptera Venom Product - Honey Bee Venom (550mcg) powder for solution |
1 February 2016 |
|
|
Injection set containing 550 micrograms with diluent |
Stallergenes Australia Pty Ltd |
HYMENOPTERA VENOM PRODUCT - Wasp Venom Protein (550 MCG) powder for solution |
1 February 2016 |
|
|
Injection set containing 550 micrograms with diluent |
Stallergenes Australia Pty Ltd |
HYMENOPTERA VENOM PRODUCT - Yellow Jacket Venom Protein (550 MCG) powder for solution |
1 February 2016 |
|
