Medicines Act 1981

Miscellaneous provisions

108: Specified publications

You could also call this:

"Important medicine guides from other countries"

Illustration for Medicines Act 1981

You need to know what a specified publication is. It means the European Pharmacopoeia, the British Pharmacopoeia, the British Pharmaceutical Codex, the United States Pharmacopoeia, the United States National Formulary, or the Therapeutic Goods Standards of Australia. When a licence or consent refers to one of these publications, it usually means the current edition. If a licence or consent does not say which edition of a publication to use, you use the current edition at the time. This includes any changes made to the publication up to that time. The current edition is the one that is in force at that particular time.

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Part 8Miscellaneous provisions

108Specified publications

  1. In this section, and for the purposes of any regulations made under this Act, specified publication means—

  2. the European Pharmacopoeia:
    1. the British Pharmacopoeia:
      1. the British Pharmaceutical Codex:
        1. the United States Pharmacopoeia:
          1. the United States National Formulary:
            1. the Therapeutic Goods Standards of Australia.
              1. Where any licence or consent or approval under this Act refers to a specified publication, but not to a particular edition of that publication, then, for the purpose of determining whether anything done, at a time when the licence, consent, or approval is in force, is done in accordance with the licence, consent, or approval, the reference shall, unless the licence, consent, or approval otherwise expressly provides, be construed as a reference to the current edition of that publication as in force at that time.

              2. In this section any reference to the current edition of a specified publication as in force at a particular time is a reference to the edition of that publication in force at that time together with any amendments, additions, and deletions made to it up to that time.

              Compare
              • Medicines Act 1968 s 103(1), (2), (5) (UK)