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Scheduling delegate's final decisions, June 2016
Scheduling of medicines and poisons
5.2 Phleum pratense extract
Part B - Final decisions on matters not referred to an expert advisory committee
5. New Chemical Entities - medicines for human therapeutic use
5.2 Phleum pratense extract
Delegate's Scheduling proposal
The delegate considered an application from the TGA for the scheduling of Phleum pretense extract, a new chemical entity for a human therapeutic medicine.
Phleum pratense extract is a standardised allergen extract of grass pollen from Timothy-grass (Phleum pratense).
Phleum pratense extract is indicated for:
- allergy immunotherapy indicated for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis;
- disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis; and
- use in persons aged 5 years or older.
Phleum pratense extract is not specifically scheduled and is not captured by any entry in the current Standard for the Uniform Scheduling of Medicines and Poisons.
Delegate's interim decision
The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.
The delegate considered the following in regards to this proposal:
- Subsection 52E(1) of the Therapeutic Goods Act 1989;
- The Scheduling Policy Framework scheduling factors;
- The TGA evaluation report;
- The new drug application.
The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.
Delegate's final decision
The delegate has made a final decision to amend the Poisons Standard to include Phleum pratense extract in Schedule 4, with an implementation date of 1 October 2016.
The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) the risks and benefits of the use of a substance; (b) the purpose and the extent of use of a substance; (c) the toxicity of a substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.
The delegate decided that the reasons for the final decision comprise the following:
- It is a new chemical entity with no clinical experience in Australia.
- It is an allergy immunotherapy indicated for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis; It is to be prescribed by medical practitioners.
- The product can cause severe anaphylactic reactions including anaphylactic shock.
- It is an oral tablet, and the initial treatment should only be undertaken under medical supervision.
- After taking the tablet, patients require to be monitored for half an hour at a medical facility.
The delegate has decided that the wording for the schedule entry will be as follows:
Schedule 4 - New Entry
PHLEUM PRATENSE POLLEN EXTRACT (Timothy-grass pollen extract).