Western Australian Consolidated Regulations Western Australian Consolidated Regulations (1) This permit shall,
subject to the succeeding provisions of this regulation, authorise the holder
to procure from any manufacturer or wholesale supplier specified therein and
to supply to certain persons, samples of poisons included in Schedule 2,
3 or 4 and the permit shall be in the Form 6B in Appendix A.
(1a) A permit under
this regulation may not be issued in respect of a drug declared to be a
specified drug for the purposes of the Act.
(2) A permit under
this regulation may be granted only to a person who is —
(a) a
representative of a person —
(i)
licensed to manufacture poisons or to supply poisons by
wholesale dealing; or
(ii)
licensed under the provisions of the laws of any other
State or Territory of the Commonwealth to manufacture poisons or to supply
poisons by wholesale dealing;
(b) not
less than 21 years of age; and
(c) of
good character,
and the holder of a
permit shall, for the purposes of these regulations, be known as a detailer.
(3) A permit under
this regulation shall contain the name and address of the detailer and the
name of each manufacturer or wholesale supplier whom he represents.
(4) Where a detailer
ceases to represent a manufacturer or wholesale supplier named in his
permit —
(a) the
permit shall thereupon cease to authorise the detailer to procure samples from
that manufacturer or wholesale supplier or to supply to any person samples
procured at any time from that manufacturer or wholesale supplier;
(b) the
detailer shall return to the manufacturer or wholesale supplier any samples
that were procured from the manufacturer or wholesale supplier and that are
still in the possession or control of the detailer; and
(c)
within 7 days of ceasing to represent the manufacturer or wholesale
supplier, the detailer shall advise the CEO in writing of the fact and deliver
up therewith his permit to the CEO and the CEO shall delete from the permit
the name of the manufacturer or wholesale supplier or shall cancel the permit,
as the case requires.
(5) A detailer shall
not supply a sample to any person who is not —
(a) a
medical practitioner;
(b) a
veterinary surgeon;
(c) a
dentist; or
(d) a
pharmacist.
(6) A detailer shall
not procure, carry or supply a sample —
(a) in
the case of an oral contraceptive, for more than 2 months use; or
(b) in
any other case, for more than 7 days use,
where the use is in
accordance with directions with the sample for maximum dosage, unless the
person wishing to be supplied with a larger sample has first made a written
request to the manufacturer or wholesale supplier represented by the detailer
for the supply of the sample.
(7)
Subregulation (6) does not apply to a sample of a proprietary preparation
where —
(a) the
sample is the smallest size manufactured for sale; and
(b) the
CEO, on the recommendation of the Poisons Advisory Committee, has declared
such a sample to be a sample to which subregulation (6) does not apply,
notwithstanding that the sample may be used —
(i)
in the case of an oral contraceptive, for more than
2 months; or
(ii)
in any other case, for more than 7 days,
where the use is in
accordance with directions with the sample for maximum dosage.
(8) A detailer shall
not carry more than —
(a) 25
samples of any single proprietary preparation; or
(b)
samples of more than 5 different proprietary preparations,
in a vehicle at any
one time.
(9) Where the proper
storage of a poison requires that poison be stored under special conditions or
at specific temperatures, a detailer shall not store or transport that poison
except in a manner which maintains those conditions or temperatures.
(10) Subject to
subregulation (11), a detailer shall not cause or permit samples in his
possession or control to be stored other than —
(a) on
the premises of the manufacturer or wholesale supplier whom he represents; or
(b) at
his address as specified in his permit.
(11) A detailer may
keep samples in a vehicle while he is actually using that vehicle in the
course of his business, but at no other time.
(12) Where pursuant to
this regulation samples are stored at an address specified in a
detailer’s permit which is not a wholesale supplier’s premises,
the detailer shall cause those samples to be stored in a locked cupboard or
locked refrigerator and a detailer shall not cause or
permit —
(a) more
than 100 samples of any single proprietary preparation; or
(b)
samples of more than 5 different proprietary preparations,
to be kept at that
address at any one time.
(13) A detailer shall
not supply a sample unless —
(a) he
has received a signed request from a person to whom he is authorised in
accordance with subregulation (5) to supply the sample; and
(b)
immediately upon supplying the sample, he signs and dates the request form to
certify that the sample has been delivered.
(14) A detailer shall
keep a record of every sample received or supplied by him and shall preserve
all records so kept together with consignment notes, invoices, advice notes
and request forms relating thereto, for not less than 2 years.
(15) Upon receiving a
written request from the CEO a detailer shall submit all records of samples
received and delivered and shall make an account of those samples to the CEO
or a person authorised in accordance with section 54 of the Act.
(16) For the purposes
of this regulation —
proprietary preparation means one or more forms of
a poison intended for therapeutic use boxed or wrapped in a single sample
package;
sample means a sample package containing a poison
intended for therapeutic use included in Schedule 2, 3 or 4.
[Regulation 8A inserted in Gazette
22 Sep 1969 p. 2874-6; amended in Gazette 29 Jun 1984
p. 1784; 12 Apr 1991 p. 1608; 16 Apr 1992
p. 1634; 7 Aug 1992 p. 3865; 25 Jun 1993
p. 3079 and 3085; 26 May 1994 p. 2201;
19 Mar 1996 p. 1218; 15 Dec 2006 p. 5630.]
[Heading deleted in Gazette 12 Aug 2003 p. 3663.]