Personal Importation - Patients travelling back into Australia with Schedule 4 and 8 unapproved cannabis medicines only

 

Note:  Personal Importation only applies to patients travelling back into Australia or a carer travelling with the patient holding a valid prescription issued by a State/Territory registered medical practitioner and the cannabis medicines are classified as Schedule 4 or 8 medicines in the SUSMP ie CBD or nabiximols respectively.

 

A patient or a carer travelling overseas with the patient may bring cannabis medicines back into Australia on their person only in the case of prescription medicines (ie, Schedules 4 and 8 of the Poisons Standard), and where the

goods are the subject of a prescription issued by a State/Territory registered medical practitioner.  No import permit/licence is required. 

 

Personal importation occurs when:

 

• an individual either brings a therapeutic good into Australia on their person or arranges from within Australia for a therapeutic good to be sent to them from an overseas supplier; and

 

• the goods are to be used by that individual or a member of his/her immediate family and are not sold or supplied to any other person.

 

The principal legislation relevant to the personal importation of therapeutic goods in Australia includes:

 

• the Therapeutic Goods Act 1989;the Therapeutic Goods Regulations 1990;

• the Customs Act 1901;

• the Customs (Prohibited Imports) Regulations 1956 (C(PI) Regulations); and

• State and Territory laws.

 

Individuals may import medicines and ‘other therapeutic goods’ without the goods being entered on the ARTG where:

 

• the goods are either for use by the importer or a member of the importer's immediate family, and

• the goods do not contain a substance which is a prohibited import under the C(PI) Regulations, and

• the quantity imported does not exceed three months' supply per importation and the total quantity imported per year does not exceed 15 months' supply at the manufacturer's recommended maximum dosage; or

• importation of the goods is approved under regulation 5 of the C(PI) Regulations or the goods are included in a gazetted class approved for importation under regulation 5; and

• in the case of prescription medicines (ie, Schedules 4 and 8 of the Poisons Standard), the

  goods are the subject of a prescription issued by a State/Territory registered medical practitioner.

 

Note: Medicines carried by a passenger on a plane or ship are an exception to this requirement, however, an import licence is still required in the case of medicines in Schedule 4 of the C(PI) Regulations if the passenger does not have a prescription.  

 

Note: Schedule 4 in the Customs Regulations is not to be confused with Schedule 4 of the SUSMP  ie prescription only medicines such as CBD and nabiximols.  The SUSMP is a Standard and comes under different legislation, the TGAct 1989. 

 

 

Note: Please check with the TGA or your State/Territory Health department before travelling back into Australia with any cananbis medicines and ensure that the cannabis medicines are included in Schedule 4 or 8 of the SUSMP as the Customs Act requires that approval to import a prohibited good must be obtained prior to arrival of the goods in Australia.  There are no powers under the Customs Act for retrospective import approval for substances already landed.

 

Note Schedule 9 Cannabis: Personal Importation is not available for Schedule 9 medicines and requires a doctor to apply to the TGA for SAS Category B approval and a doctor/pharmacist to apply for an import permit and/or licence under the SAS.  People who import these medicines without TGA approval are liable to prosecution.

 

RESPONSIBILITIES OF THE ‘PERSONAL IMPORTER

 

• Individuals wishing to import unapproved products for their personal use should be aware that in many cases the quality, safety and efficacy of the goods may be unknown and they must therefore be prepared to accept any risks associated with the use of such products. If an individual suffers adverse consequences from taking such medicines, information about the goods and redress may be difficult to obtain.

 

• It is the responsibility of individuals wishing to arrange personal importation of unapproved therapeutic goods to ensure they have complied with all relevant Commonwealth and State/or Territory laws. When seeking to arrange importation of an unapproved medicine, it is important to check whether the medicine is controlled under Customs (Prohibited Import) Regulations 1956, in which case special requirements for TGA approval prior to importation apply. In addition, goods imported into Australia, whether therapeutic or not, may be subject to import controls administered under the Quarantine Act 1908 and the Environment Protection and Biodiversity Conservation Act 1999 if the products are manufactured from animal, plant or human materials. 

 

• It is also a requirement under the Act for an individual to obtain through their supervising physician a Section 19 or Section 41HB (Special Access Scheme) approval for the importation of single quantities in excess of 3 months supply of a therapeutic good or more than 15 months supply in a 12 month period.​

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SITUATIONS WHERE PERSONAL IMPORTATION IS FURTHER REGULATED

 

Customs controls apply to certain therapeutic goods such as drugs of dependence, antibiotics and other substances that may be dangerous if used therapeutically. The Australian Customs Service will only allow products containing these substances to be imported if written permission for importation has been given by the TGA. The TGA considers the use of these products should be supervised by a medical practitioner.

 

Special approval from the TGA for the purpose of the C(PI) Regulations is required prior to importation of:

medicines subject to control under Regulation 5 of the C(PI) Regulations and listed in Schedule 4 to those regulations. This includes medicines with the potential to cause dependence or which have a propensity for abuse, such as narcotics, amphetamines and psychotropic substances.

 

Thus, the TGA will not issue import permits to individuals. Instead, TGA requires applications to be made in writing by the individual's supervising physician under the Special Access Scheme – see below.

 

Further advice about procedures for importation of medicines should be sought from the Experimental Drugs Section, Drug Safety and Evaluation Branch, TGA, telephone (02) 6232 8111, fax (02) 6232 8112 or mail PO Box 100 Woden ACT.

 

Further advice about procedures for importation should be sought from the Treaties and Monitoring Unit, TGA, telephone (02) 6270 4322, fax (02) 6270 4325 or mail PO Box 100 Woden ACT 2606.