Federal Register of Legislation - Australian Government

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TGO 70C Orders/Other as made
This order revokes Therapeutic Goods Order No. 70B - Standards for Export Only Medicine and specifies pharmacopoeia (the British, European, United States and Japanese pharmacopoeias) that constitute alternative standards for medicines made in Australia, or imported into Australia, solely for export.
Administered by: Health
Registered 06 Jun 2014
Tabling HistoryDate
Tabled HR16-Jun-2014
Tabled Senate16-Jun-2014

 

Therapeutic Goods Act 1989

THERAPEUTIC GOODS ORDER No. 70C

Standards for Export Only Medicine

I, Larry Kelly, delegate of the Minister for Health for the purposes of section 10 of the Therapeutic Goods Act 1989 (the Act) and acting under that section, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the Act, HEREBY:

  1. REVOKE Therapeutic Goods Order No.70B  "Amendment to Therapeutic Goods Order No. 70 - Standards for Export Only Medicine", made on 26 February 2007; and
  2. 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 requirements (if any) set out in column 2 below:

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Column 1

Column  2

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British Pharmacopoeia, United States Pharmacopoeia

and European Pharmacopoeia

(as each are defined in subsection 3(1) of the Act)

i) 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 of that country for such products.

 

 

 

 

 

Japanese Pharmacopoeia (16th edition including English language translation of Supplement 1 of April 2013 and partial revision of Supplement 1 of May 2013)

i) 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

ii) 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 of that country for such products.

 

 

 

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This Order commences on the day after the day it is registered on the Federal Register of Legislative Instruments.

Dated this 16th            day of May 2014

 

(Signed by)

Dr Larry Kelly
Delegate of the Minister for Health