Document ID: chunk:federal_register_of_legislation:F2024L01211:clause:1_7
Version: federal_register_of_legislation:F2024L01211
Segment Type: clause
Provision Reference: sch 1 cl 7
Character Range: 2610–3260

7  Requirements
  An export only medicine must:
 (a) comply with the requirements specified in the applicable individual, specific and general monographs in at least one of the following pharmacopoeia, as interpreted in accordance with the General Notices section of the relevant pharmacopoeia:
 (i) the British Pharmacopoeia;
 (ii) the European Pharmacopoeia;
 (iii) the Japanese Pharmacopoeia;
 (iv) the United States Pharmacopoeia-National Formulary; and
 (b) where the export only medicine is not regulated as a medicine in the country to which it is to be exported—meet the regulatory requirements of the country to which it is to be exported.