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I want to manufacture (or import) and supply herbs or other substances (or products) for the benefit of people’s health. What do I need to do to do so legally?

If you want to supply any product for which a therapeutic use is claimed, you will need to be licensed as a sponsor by the Commonwealth Therapeutic Goods Administration (TGA) and each product will need to be included in the Australian Register of Therapeutic Goods, unless exempted by the TGA. Contact the TGA by telephone on 1800 020 653 for further information.

It should be noted that ‘claiming’ a product has a therapeutic use includes making a statement on any label, website, pamphlet or in any other form that a product will treat, cure or prevent any disease or affect human fertility.

If you want to supply any product or substance (or ‘derivative’ of a substance) which is included in Schedule 2, 3 or 4 of the NSW Poisons List you will need a licence issued by the NSW Ministry of Health to supply poisons or restricted substances by wholesale.

If you want to supply any product or substance (or ‘derivative’) which is included in Schedule 8 of the NSW Poisons List, you will need a licence to manufacture or supply drugs of addiction. Application forms can be accessed online and are managed by the Private Health Care Unit of the NSW Ministry of Health.

You may need to obtain advice from a chemist or pharmacologist as to whether the substances you wish to supply are included in the Poisons Schedule entries, as each entry may include many derivatives and many substances, especially herbs, are known by several different names in different countries.

A licence is not required to supply Schedule 5 or 6 substances in NSW.

Do I need a licence to supply non-therapeutic poisons, i.e., substances in Schedules 5, 6 or 7 of the NSW Poisons List?

A licence or authority is not required to supply Schedule 5 or 6 poisons by wholesale or retail in NSW. Supply of Schedule 7 poisons for domestic use requires that both the supplier and the purchaser obtain prior written authority from the NSW Ministry of Health.

For authority to possess cyanide, download and use the form Application for an Authority or Renewal of an Authority to Obtain Cyanide.

For authority to possess any other schedule 7 substance (e.g. arsenic), contact the Duty Pharmaceutical Officer at Pharmaceutical Services on (02) 9391 9944 during business hours.

How do I need to package and label substances which are included in the NSW Poisons List other than medicines dispensed by a pharmacist or other authorised health practitioner?

They must be packaged and labelled in accordance with the requirements of the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP). A guide to labelling drugs and poisons is available online from the Therapeutic Goods Administration (TGA).

It should be noted that some substances/medicines are required to be packed with child resistant closures. Further information is available online from the Therapeutic Goods Administration (TGA).

Where can I store medicines or poisons in my shop (or wholesale) premises?

All restricted substances (Schedule 4) and pharmacist only medicines (Schedule 3) must be stored in a room or enclosure to which the public does not have access. Additional storage requirements apply to substances of high illicit value.

Wholesalers must comply with the Australian code of good wholesaling practice for medicines in Schedules 2, 3, 4 & 8, available online from the Therapeutic Goods Administration.

Schedule 6 poisons in a retail shop must be stored at least 1.2 metres off the floor (and away from any stairway) unless in a container which meets the legal requirements for a child-resistant container/closure.

Can I supply Schedule 2, 3, 4 or 8 substances to researchers or analysts?

Schedule 2, 3 or 4 substances may be supplied to a scientifically qualified person who is in charge of a laboratory or department, or a person acting under the direct personal supervision of such a person, if use of that substance is required for the conduct of medical or scientific research or instruction or the conduct of quality control analysis.

To supply a Schedule 8 substance, the person making the request must supply a written authority from the NSW Ministry of Health. If you unsure about a request, contact the Duty Pharmaceutical Officer at Pharmaceutical Services on (02) 9391 9944 during business hours.

Current as at: Monday 24 May 2021
Contact page owner: Pharmaceutical Services