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Prescription medicines determination and designation notices

What is determination?

Determination is a formal process that allows the TGA to make a decision regarding whether a medicine is eligible for registration via the provisional approval pathway or the priority review pathway.

The sponsor of the medicine must submit an application for determination to allow the TGA to make a decision on whether the medicine meets the eligibility criteria. These eligibility criteria are designed to ensure that only products providing the most benefit to patients are eligible. Eligibility criteria for provisional determination and priority review determination are published on our website.

Designation is similar to determination, but in this case, it allows the TGA to make a decision regarding whether a medicine is eligible for Orphan drug status. More information on our orphan drug program is available at the Orphan drug program reforms webpage.

Amendments to the Therapeutic Goods Regulations 1990 which came into effect on 1 July 2017 changed the eligibility criteria for orphan drug designation. A transition period applies to orphan drugs designated under the previous orphan drug program. A list of orphan drugs designated under the previous program is available.

A determination or designation does not mean that the medicine has been approved and registered in the Australian Register of Therapeutic Goods (ARTG).

To register a medicine after obtaining a designation or determination, the sponsor must lodge an application for registration. These applications are subject to a rigorous evaluation process resulting in a TGA decision on whether the medicine should be registered on the ARTG. Details of registered products approved for supply in Australia can be obtained by searching the ARTG

Orphan designations, priority review and provisional determinations remain in force for a period of 6 months from the initial effective date.

Provisional determinations and orphan drug designations may be extended for a further six months on application by the sponsor. We will grant one extension if all eligibility criteria for the relevant extension are met. A priority review determination cannot be extended.

Details of prescription medicines that have an approved provisional determination, priority review determination or orphan drug designation are listed below.

Approved determinations and designations for prescription medicines

Agepha Pharma Pty Ltd

Designation/determination: Orphan drug

Effective Date: 08/05/2019

Lapse Date: 08/11/2019

Medicine Name: aciclovir 30 mg/g ophthalmic ointment

Dosage Form(s): eye ointment

For the treatment of superficial, acute and recurrent herpes simplex infections of the cornea: herpetic keratitis.

Therapeutic area: Infectious diseases

Roche Products Pty Limited

Designation/determination: Provisional approval

Effective Date: 17/04/2019

Lapse Date: 17/10/2019

Medicine Name: entrectinib

Therapeutic area: Oncology

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 29/03/2019

Lapse Date: 29/09/2019

Medicine Name: voretigene neparvevec

Dosage Form(s): Suspension for sub-retinal injection

Treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

Therapeutic area: Opthalmology

Emerge Health Pty Ltd

Designation/determination: Orphan drug

Effective Date: 29/03/2019

Lapse Date: 29/09/2019

Medicine Name: hydrocortisone

Dosage Form(s): oral granules in capsule for opening

Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).

Therapeutic area: Endocrnology

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 05/03/2019

Lapse Date: 05/09/2019

Medicine Name: trastuzumab emtansine

Trastuzumab emtansine, as a single agent, is indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual disease after pre-operative systemic treatment that included HER2-targeted therapy.

Shire Australia Pty Limited

Designation/determination: Orphan drug

Effective Date: 26/02/2019

Lapse Date: 26/08/2019

Medicine Name: teduglutide

Dosage Form(s): Injection solution

For the treatment of paediatric patients with Short Bowel Syndrome (SBS)

Therapeutic area: Gastroenterology

Bristol-Myers Squibb Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 26/02/2019

Lapse Date: 26/08/2019

Medicine Name: dasatinib

Dosage Form(s): Tablet, film-coated

For the treatment of paediatric patients with chronic myeloid leukaemia

Therapeutic area: Haematology

link Medical Products Pty Ltd T/A Link Pharmaceuticals

Designation/determination: Orphan drug

Effective Date: 21/02/2019

Lapse Date: 21/08/2019

Medicine Name: defibrotide

Dosage Form(s): Injection solution

For the treatment of hepatic veno-occlusive disease (VOD)

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Designation/determination: Orphan drug

Effective Date: 19/02/2019

Lapse Date: 19/08/2019

Medicine Name: trientine dihydrochloride

Dosage Form(s): capsule

For the treatment of Wilson's Disease

Sanofi-Aventis Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 29/01/2019

Lapse Date: 29/07/2019

Medicine Name: caplacizumab

Dosage Form(s): Injection, intravenous

For the treatment of Thrombotic Thrombocytopenic Purpura (TTP)

Therapeutic area: Haematology

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