Commonwealth Numbered Acts

Health Acts Amendment Act 1981 No. 118 of 1981 - SECT 82

82. Section 5 of the Principal Act is amended-

(a) by inserting in sub-section (1) before the definition of ''general
standard'' the following definitions:

'' 'batch' includes a number of batches and a part of a batch;

'' 'British Pharmaceutical Codex' means the book called the British
Pharmaceutical Codex published by direction of the Council of the
Pharmaceutical Society of Great Britain;

'' 'British Pharmacopoeia' means-

   (a)  the latest edition (being an edition that has taken effect for the
        purposes of this Act in accordance with section 6) for the time being
        of the book called the British Pharmacopoeia published under the
        direction of the Medicines Commission of the United Kingdom; or

   (b)  if that edition has been added to or amended by additions or
        amendments that have taken effect for the purposes of this Act in
        accordance with section 6-that edition as affected by those additions
        or amendments;

'' 'British Pharmacopoeia (Veterinary)' means the book called the British
Pharmacopoeia (Veterinary) published on the recommendation of the Medicines
Commission of the United Kingdom;

'' 'British Veterinary Codex' means the book called the British Veterinary
Codex published by direction of the Council of the Pharmaceutical Society of
Great Britain;

'' 'Director-General' means the Director-General of Health;

'' 'European Pharmacopoeia' means the book called the European Pharmacopoeia
published in accordance with the terms of the convention known as the
Convention on the Elaboration of a European Pharmacopoeia;

'' 'former British Pharmacopoeia' means the book called the British
Pharmacopoeia published under the direction of the General Medical Council of
the United Kingdom;'';

   (b)  by omitting from sub-section (1) the definition of ''specific
        standard'' and substituting the following definitions:

'' 'orthotics' means the complementing, supplementing or replacing of a
physiological function of the body and includes the provision of contact
lenses, hearing aids, heart pace-makers and similar aids;

'' 'Pharmaceutical Codex' means the book called the Pharmaceutical Codex
published by direction of the Council of the Pharmaceutical Society of Great
Britain;

'' 'prescribed corporation' means a foreign corporation, or a trading
corporation formed within the limits of the Commonwealth, within the meaning
of paragraph 51 (xx) of the Constitution;

'' 'prescribed publication' means-

   (a)  the British Pharmaceutical Codex;

   (b)  the British Pharmacopoeia (Veterinary);

   (c)  the British Veterinary Codex;

   (d)  the former British Pharmacopoeia; or

   (e)  the Pharmaceutical Codex;

'' 'prosthetics' means the making up of a deficiency in the body and includes
the provision of dentures, artificial organs or limbs or similar aids;

'' 'relevant date' means the date of commencement of Part V of the Health 
Acts Amendment Act 1981 ;

'' 'specific standard', in relation to goods for therapeutic use, means a
standard for a substance or article of which the goods consist, or are
represented to consist, that-

   (a)  if the goods are for human use-

        (i)    is specified in an order under section 11 that has effect in
               relation to goods for human use; or

        (ii)   where a standard for the substance or article is not specified
               in such an order but the substance or article is the subject of
               a monograph in the British Pharmacopoeia-is constituted by the
               statements in that monograph; or

   (b)  if the goods are for veterinary use-is specified in an order under
        section 11 that has effect in relation to goods for veterinary use;'';

   (c)  by omitting from sub-section (1) the definitions of ''the British
        Pharmaceutical Codex'', ''the British Pharmacopoeia'', ''the British
        Veterinary Codex'' and ''therapeutic use'' and substituting the
        following definitions:

'' 'supply' includes-

   (a)  supply by way of sale, exchange, gift, lease, hire or hire-purchase;

   (b)  supply (whether free of charge or otherwise) by way of sample or
        advertisement; and

   (c)  supply (whether free of charge or otherwise) in the course of research
        undertaken to test the safety or efficacy of goods for therapeutic
        use;

'' 'therapeutic use' means use in, or in connection with-

   (a)  the preventing, diagnosing, curing or alleviating of a disease,
        ailment, defect or injury in persons or animals;

   (b)  the influencing, inhibiting or modifying of a physiological process in
        persons or animals; or

   (c)  the testing of the susceptibility of persons or animals to a disease
        or ailment,

and, without limiting the generality of the foregoing, includes use in, or in
connection with, testing for pregnancy, contraception, prosthetics or
orthotics.''; and

   (d)  by adding at the end thereof the following sub-sections:

''(5) Where a statement in a monograph in a publication refers to a statement
in a monograph in another publication, the statement in the monograph in the
other publication shall be deemed to be a statement in the first-mentioned
monograph.

''(6) A monograph in the British Pharmacopoeia that purports to reproduce
statements in a monograph in the European Pharmacopoeia shall not be construed
for the purposes of this Act by reference to the monograph in the European
Pharmacopoeia notwithstanding anything to the contrary in the British
Pharmacopoeia.

''(7) A reference in this Act to a book, other than the British Pharmacopoeia,
shall be read as a reference to any edition of that book, whether published
before or after the relevant date, or any such edition as added to or amended
by any addition to or amendment of that edition.

''(8) A reference in this Act to goods for therapeutic use does not include a
reference to goods for use in, or in connection with, testing for pregnancy,
contraception, prosthetics or orthotics unless the goods are declared, or are
included in a class of goods that are declared, by the regulations to be goods
for therapeutic use to which this Act applies.''.