Therapeutic Goods Act 1989
THERAPEUTIC GOODS ORDER No. 70B
Standards for Export Only Medicine
I, DAVID GRAHAM, delegate of the Minister for Health and Ageing for the purposes of section 10 of the Therapeutic Goods Act 1989 and acting under that section, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of that Act, HEREBY:
REVOKE Therapeutic Goods Order No. 70 "Standards for Export Only Medicine" (TGO 70) made on 20 May 2002; REVOKE Therapeutic Goods Order No. 70A "Amendment to Therapeutic Goods Order No. 70 - Standards for Export Only Medicine" (TGO 70A) made on 5 December 2003; and DETERMINE that the matters specified in a relevant monograph of each of the publications listed in column 1 below constitute alternative standards for medicine manufactured in Australia, or imported into Australia, for export only subject to the limitations (if any) set out in column 2:
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Column 1
Column  2

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British Pharmacopoeia (2005 edition)
i) the medicine is not to be supplied for sale in Australia, including
supply via duty free outlets; and
ii) if the medicine to be exported or any ingredient in the medicine to be exported is subject to the Customs (Prohibited Exports) Regulations 1958, an export permit has been obtained by the relevant authority (in Australia) prior to its export.

 
 

United States Pharmacopoeia
(29th edition-NF 24)
 i) the medicine is not to be supplied for sale in Australia, including
supply via duty free outlets; and
ii) the exporter is to hold evidence that a relevant authority of the          country to which the medicine is to be exported has confirmed its willingness to accept medicine which complies with this order, or confirmed that it would have no objection to accepting such medicine, except where the country to which the medicine is to be exported is a country where the medicine is regulated other than as a medicine;
iii)  if the medicine is regulated other than as a medicine in the country to which it is to be exported, it meets the regulatory requirements set out by that country for such products; and
iv) if the medicine to be exported or any ingredient in the medicine to be exported is subject to the Customs (Prohibited Exports) Regulations 1958, an export permit has been obtained by the relevant authority (in Australia) prior to its export.
 

Japanese Pharmacopoeia (14th edition including Supplements I and II)
 
i) the medicine is not to be supplied for sale in Australia, including
supply via duty free outlets; and
ii) the exporter is to hold evidence that a relevant authority of the          country to which the medicine is to be exported has confirmed its willingness to accept medicine which complies with this order, or confirmed that it would have no objection to accepting such medicine, except where the country to which the medicine is to be exported is a country where the medicine is regulated other than as a medicine;
iii)  if the medicine is regulated other than as a medicine in the  country to which it is to be exported, it meets the regulatory requirements set out by that country for such products; and
iv) if the medicine to be exported or any ingredient in the medicine to be exported is subject to the Customs (Prohibited Exports) Regulations 1958, an export permit has been obtained by the relevant authority (in Australia) prior to its export.
 

European Pharmacopoeia (5th edition including Supplements 5.1 -5.6)
i) the medicine is not to be supplied for sale in Australia, including
supply via duty free outlets; and
ii) the exporter is to hold evidence that a relevant authority of the          country to which the medicine is to be exported has confirmed its willingness to accept medicine which complies with this order, or confirmed that it would have no objection to accepting such medicine, except where the country to which the medicine is to be exported is a country where the medicine is regulated other than as a medicine; and
iii)  if the medicine is regulated other than as a medicine in the country to which it is to be exported, it meets the regulatory requirements set out by that country for such products; and
iv) if the medicine to be exported or any ingredient in the medicine to be exported is subject to the Customs (Prohibited Exports) Regulations 1958, an export permit has been obtained by the relevant authority (in Australia) prior to its export.
 

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This Order commences from the day after the day it is registered on the Federal Register of Legislative Instruments.
Dated this  twenty sixth  day of February 2007
 
 
 
David Graham
Delegate of the Minister for Health and Ageing