cannepil question and other questions, page-15

20 November 2017
HL Pharma has over 20 years of experience as a specialist supplier of unregistered pharmaceuticals (pharmaceuticals that are not registered with the Therapeutic Goods Agency (TGA), but are registered with other recognised pharmaceutical regulators) products in Australia. It sources products only from registered suppliers, which have a pharmaceutical wholesale or manufacturing license and are typically registered with the Medicines and Health Regulatory Agency (MHRA) in the UK

The Company has already been working closely with Epilepsy Action Australia (EAA), with which it has an existing relationship, and its scientific board of advisors to build its Australian patient market through the registration of authorised prescribing doctors. An initial group of at least five doctors have already formally registered interest in prescribing the product and are currently in the process of applying for their authorised prescriber status with the Australian regulatory authorities.


HL Pharma
Within Australia, pharmaceuticals that are not registered with the Therapeutic Goods Agency (TGA) are considered unregistered. However, this does not necessarily mean they cannot to be used or are unsafe. They are often licensed products and valid in other geographical regions that have been tested, approved and manufactured under Good Manufacturing Practice (GMP). A product that is licensed by the MHRA in the UK but is yet to be registered in Australia with the TGA, would be considered an unregistered product here in Australia, if it is required for a patient there are various methods of obtaining it and HL Pharma can assist you in doing so.
Sometimes Australian registered products become unavailable here in Australia but are still available overseas. The overseas product would be considered an unregistered Australian product. HL Pharma can organise the supply. Pharmaceutical compounded products are also unregistered. Compounded products made by a pharmacist usually have no validated expiry date data or validated certificate of analysis. They may be prepared in facilities that are not registered with the TGA. Products licensed overseas will have validated expiry dates, certificates of conformity and will have appropriate data for approval within the countries they are licensed in.
In Australia there are various methods available to gain access to unregistered/unlicensed products. These include:

• The Special Access Scheme
• The Authorised Prescriber Scheme
• The Personal Access Scheme
• Exemptions under The Therapeutic Goods Regulations.

HL Pharma can provide information on the most appropriate method of obtaining these types of products. The use of unregistered/unlicensed pharmaceuticals is quite common but all those involved in the process, from the doctor, pharmacist to the patient, should make an informed decision when deciding to use these products. HL Pharma also exports pharmaceuticals to licensed facilities.


The Office of Drug Control