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General approvals

General approvals are a type of substance authority that may be granted under the Medicines and Poisons Act 2019 (MPA). You can find out more about:

General approvals for medicines may be granted to entities (or individuals) to carry out activities that are not already authorised. General approvals authorise the holder of the approval, or persons stated in the approval, to carry out the activities stated in the approval with the regulated substances stated in the approval.

The Medicines and Poisons (Medicines) Regulation 2021 (MPMR) prescribes 3 different classes of general approvals for carrying out different types of regulated activities:

  1. General approval (emergency first aid) for carrying out the regulated activities that are dealings with medicines mentioned in Schedule 16, Part 2.
  2. General approval (acute health conditions at isolated sites) for carrying out the regulated activities that are dealings with medicines mentioned in Schedule 16, Part 1.
  3. General approval (emergency management of animals) for carrying out the regulated activities that are dealings with medicines mentioned in Schedule 16, Part 3.

In addition to these three classes, bespoke general approvals may also be granted to applicants to cater for unique or unusual circumstances. Applications for such general approvals will be considered carefully, on their merits, and having regard to specific criteria.

Requirements for general approvals

  • Approvals granted under the Health (Drugs and Poisons) Regulation 1996 (HDPR) are not renewable. All applicants must submit new (initial) applications under the MPA in the first instance.
  • Approvals granted under the HDPR continue until expired, surrendered or cancelled, unless no longer required under the MPA, in which case it ceases on commencement.
  • To apply for a general approval, have a relevant person complete a Details of relevant person form (PDF 362 kB). Further information on who must complete this form is on the application form.
  • Some holders of general approvals will be required to have a substance management plan (SMP).
  • All general approval holders must maintain records and report incidents such as loss/theft of medicines to the Chief Executive, Queensland Health. Find out more about reporting an incident by visiting Reporting medicines matters to the chief executive.
  • All general approval holders must notify the Chief Executive, Queensland Health of changes in circumstances affecting their approval. To do so, see Reporting medicines matters to the chief executive.

Emergency first aid

A general approval may be granted for the provision of emergency first aid. For further information on this class of general approval, including when one is not required, read Emergency first aid (PDF 219 kB).

To apply for a new general approval (emergency first aid), or to renew or amend an existing approval, complete the relevant application form. All applications will be new (initial) applications under the MPA in the first instance.

For entities granted an approval seeking to give notice to the chief executive of intention to attend an event, medicines usage, change in circumstances or an intention to stop dealing, please complete the relevant notice by following the instructions on Reporting medicines matters to the chief executive.

Acute health conditions at isolated sites

A general approval may be granted for the treatment of acute health conditions at isolated sites. In this context an ‘isolated site’ is a remote site for which limited medical and pharmaceutical services are available (e.g. a mine site or island resort) Read more about Acute health conditions at isolated sites (PDF 274 kB).

To apply for a new general approval (acute health conditions at isolated sites), or to renew or amend an existing approval, complete the relevant application form. All applications will be new (initial) applications under the MPA in the first instance.

For entities granted an approval seeking to give notice to the chief executive of change in circumstances or intention to stop dealing, complete this notice through our online portal.

Emergency management of animals

A general approval may be granted for the purpose of the emergency care and treatment of sick, injured or orphaned animals. Read more about Emergency management of animals (PDF 242 kB).

Only a ‘qualified person’ working for the holder of an approval may administer medicines under this type of approval. The MPMR states that, in this context, a ‘qualified person’ means a person who has—

  1. completed a training course approved by the chief executive about the safe administration of medicines to animals; or
  2. skills and knowledge equivalent to the competency the person would achieve by completing the training course mentioned in paragraph (a), as stated in writing by a veterinary surgeon.

The guideline Competency requirements for the emergency management of animals (PDF 197 kB) specifies the training courses approved by the chief executive for this purpose and establishes the minimum competency requirements for persons administering medicines to animals under a general approval (emergency management of animals) for assessment by veterinary surgeons.

For entities granted an approval seeking to give notice to the chief executive of medicines usage, a change in circumstances or an intention to stop dealing, please complete this notice by following the instructions on Reporting medicines matters to the chief executive.

Immunisation program

A general approval may be granted for providing an immunisation program by registered nurses. These immunisation programs are not for the provision of COVID-19 vaccines. Find out more about COVID-19 vaccines.

Applications for a general approval to provide an immunisation program must meet the requirements set out in the Extended Practice Authority for Registered Nurses (PDF 245 kB). Find out more about Immunisation programs (PDF 219 kB).

For entities granted an approval seeking to give notice to the chief executive of change in circumstances or intention to stop dealing, please complete the relevant notice by following the instructions on Reporting medicines matters to the chief executive.

Other general approvals to use medicines or prohibited substances for therapeutic purposes

To seek approval to use a regulated substance for a therapeutic purpose not covered by one of the above categories, use:

If you hold a non-specific general approval (for therapeutic use) and are seeking to renew or amend your approval, complete:

Related information

Contact

Healthcare Approvals and Regulation Unit (HARU): HARU@health.qld.gov.au.

Last updated: 24 September 2021