Section 19A medicines subsidised by the Pharmaceutical Benefits Scheme

Page last updated: 1 January 2022

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.

List of Section 19A products subsidised by the Pharmaceutical Benefits Scheme

Section 19A  medicine

Section 19A Responsible person

TGA Section 19A  approval

Date PBS listed 

Notes

Hydromorphone

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.

Tocilizumab

Concentrate for injection 80 mg in 4 mL s19A

Medsurge Healthcare Pty Ltd

RoActemra tocilizumab 80mg/4mL concentrate for solution for infusion (Roche Germany)

1 November 2021

PBS subsidised as Authority Required benefits for the treatment of Systemic juvenile idiopathic arthritis only.

Tocilizumab

Concentrate for injection 200 mg in 10 mL s19A

Medsurge Healthcare Pty Ltd

RoActemra tocilizumab 200 mg/ 10mL concentrate for solution for infusion (Roche Germany)

1 November 2021

PBS subsidised as Authority Required benefits for the treatment of Systemic juvenile idiopathic arthritis only.

Tocilizumab

Concentrate for injection 400 mg in 20 mL s19A

Medsurge Healthcare Pty Ltd

RoActemra tocilizumab 400 mg/ 20mL concentrate for solution for infusion (Roche Germany)

1 November 2021

PBS subsidised as Authority Required benefits for the treatment of Systemic juvenile idiopathic arthritis only.

Nitrofurantoin

Capsule 50 mg, USP

Medsurge Healthcare Pty Ltd

Nitrofurantoin 50mg capsules, USP (Macrocrystals) (Sun Pharma)

1 October 2021

 

Prednisolone acetate

Eye drops containing prednisolone acetate 10 mg per mL, 10 mL

Allergan Australia Pty Limited

PRED FORTE Prednisolone acetate 10mg/mL eye drops 10mL (UK)

1 September 2021

PBS subsidised to manage the shortage of Prednefrin forte. This product is not a-flagged to Prednefrin forte due to differences in active ingredients.

Adrenaline

Adrenaline (epinephrine), Solution for injection 1 mg (as tartrate) in 1 mL (1 in 1,000)

Link Medical Products Pty Ltd

ADRENALINE RENAUDIN adrenaline 1 mg/mL solution for injection, 1mL ampoule

1 August 2021

 

Hydromorphone

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.

Desmopressin

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL, USP (Apotex)

Medsurge Healthcare Pty Ltd

Desmopressin Nasal Spray 10mcg/0.1mL (Apotex)

1 June 2021

 

Desmopressin

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL

Medsurge Healthcare Pty Ltd

Desmopressin Acetate Nasal Solution (Nasal Spray) 10mcg/0.1mL per spray 5mL bottle (Zydus Pharmaceuticals)

1 March 2021

 

Phenelzine

Tablet 15 mg (as sulfate) (USP)

Generic Health Pty Ltd

Phenelzine Sulfate USP 15mg Tablets (Lupin Pharmaceuticals)

1 February 2021

 

Primidone

Tablet 250 mg, USP

Link Medical Products Pty Ltd

APO-Primidone 250mg tablets (New Zealand)

1 January 2020

 

Naloxone

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

 

Auranofin

Capsule 3 mg

Boucher & Muir Pty Ltd

RIDAURA auranofin 3mg capsules (Canada)

1 October 2017

 

Clozapine

Oral liquid 50 mg per mL, 100 mL

Pfizer Australia Pty Ltd

VERSACLOZ (clozapine) 50 mg/mL oral suspension (TruPharma)

1 August 2018

 

Phenoxybenzamine

Phenoxybenzamine, capsules containing phenoxybenzamine hydrochloride 10 mg, 30

Amdipharm Mercury (Australia) Pty Limited PHENOXYBENZAMINE 10 mg Capsules - 30 Capusles (UK)  1 March 2016

Honey Bee Venom

Injection set containing 550 micrograms with diluent

Stallergenes Australia Pty Ltd

Hymenoptera Venom Product - Honey Bee Venom (550mcg) powder for solution

1 February 2016

 

Paper Wasp Venom

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

 

Yellow Jacket Venom

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