Medicine wholesalers licence

You may need this licence to sell a licenced medicine by wholesale.

To enable access to pharmacy products in rural and remote areas, a business needs a  pharmacy medicines rural communities licence to obtain, possess and sell licensed medicines.

As a medicine wholesalers licence holder you can:

• issue a complying purchase order for a licenced medicine
• obtain a licenced medicine on a purchase order
• possess a licenced medicine for sale by wholesale from the licensed premises
• sell a licenced medicine by wholesale from the licenced premises to:
  • a person authorised to issue a purchase order for the medicine
  • someone in another state who may obtain the medicine by wholesale under the law of that state
  • someone in another country who may lawfully obtain the medicine by wholesale in that country (unless a prohibited export under the Customs Act 1901)
• unless it is a controlled medicine, supply the licenced medicine in accordance with the Medicines Australia Code of Conduct provisions for product starter packs.

Medicine wholesalers licence conditions

As a medicine wholesalers licence holder, you must ensure:

• all dealings with a medicine will be carried out under the supervision of the approved person stated in the licence.
• that you, your agents and your employees comply with the Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4, and 8 and the Medicines Australia Code of Conduct.
• medicine obtained under the licence is purchased on a complying purchase order
• medicine sold under the licence is sold on a complying purchase order.

Storage

A medicines wholesaler licence holder must ensure medicines are stored within the manufacturer’s recommended storage temperature range and in any other environmental condition that is necessary to preserve the medicine’s stability and therapeutic quality.

Controlled medicines:

• must be are stored in a locked safe, strong room or vault
• keys or lock combinations must not be accessible to, or known by, any unauthorised people.

Prescription only (S4), pharmacist only (S3) and pharmacy (S2) medicines:

• must be stored in a part of the premises where only a licensee, or a person under the direct supervision of a licensee, has access to the medicine and there is no public access.

Destruction

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

Both of you must sign the controlled medicines 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 medicine wholesalers licence holder must keep a controlled medicine, prohibited substance or 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 registers, other recording and medicines 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

Apply for a medicine wholesalers licence by completing a medicines, poisons and therapeutic goods licence application.