Research and education program licence

You may need this licence if you deal with scheduled medicines as part of an academic program or research project.

As a research and education program licence holder you can:

• issue a complying purchase order for a licenced controlled medicine, dangerous poison, or prohibited substance for a program stated in the licence
• obtain on a complying purchase order a licenced controlled medicine, dangerous poison, or prohibited substance stated in the licence
• possess a licenced controlled medicine, dangerous poison, or prohibited substance for the program at the premises stated on the licence
• supply a licenced controlled medicine, dangerous poison, or prohibited substance to anyone taking part in a program.

A research and education program supervisor, and anyone taking part in the program, is authorised to deal with a licenced controlled medicine, dangerous poison or prohibited substance as authorised by the licence and at the premises stated in the licence.

Licence holders are subject to the requirements of the Medicines, Poisons and Therapeutic Goods Regulation 2008.

Procurement of controlled medicines and poisons

Controlled medicines, dangerous poisons and prohibited substances are obtained on the authorisation of the licensee. These regulated substances are the responsibility of the licensee. Other staff are not authorised to order and receive the regulated substances

Storage

A research and education program licence holder must ensure:

• they are authorised to be in possession of a controlled medicine, dangerous poison or prohibited substance
• controlled medicines and prohibited substances are stored in a locked medicines cabinet, safe, strong room or vault
• keys and lock combinations to the storage receptacle are not be accessible to, or known by, unauthorised persons
• dangerous poisons are stored in a place where only authorised persons, and not the public, have access.

Destruction

As a licence holder, if you wish to destroy expired or unwanted controlled medicines and prohibited substances, the destruction must be witnessed by someone prescribed under Section 545 of the Medicines, Poisons and Therapeutic Goods Regulation 2008.

If you wish to destroy expired or unwanted dangerous poisons, the destruction must be witnessed by a someone prescribed under Section 743 of the Medicines, Poisons and Therapeutic Goods Regulation 2008.

Both of you must sign the controlled medicines, dangerous poisons or prohibited substances register.

Record keeping

You must be able to easily retrieve records of all dealings in controlled medicines, dangerous poisons and prohibited substances for 2 years.

A research and education program licence holder must keep a controlled medicine, prohibited substance and a dangerous poisons register at the premises where the substance is kept.

Each page must relate to a single form and strength of a controlled medicine, dangerous poison or prohibited substance.

Registers should show the accurate balance remaining after each dealing and be in a form that cannot be altered without detection.

Inspections, reporting and theft

Controlled medicines, dangerous poisons and prohibited substances registers and other recording and storage arrangements may be the subject of inspections under the Medicines, Poisons and Therapeutic Goods Act 2008.

You must notify ACT Health when controlled medicines, dangerous poisons or prohibited substances are lost or stolen, and report the theft to police.

Apply for a licence

You can apply for a research and education program licence by completing a medicines, poisons and therapeutic goods licence application.

Before completing the Medicines Poisons Therapeutic Goods Licence application form, you are urged to read the Medicines, Poisons and Therapeutic Goods Act 2008 and Medicines, Poisons and Therapeutic Goods Regulation 2008 to ensure full compliance.

If you fail to comply with ACT legislation, you may be subject to prosecution.