Locus Consulting
(ACN: 14S 426 562)
ARGOM Review Project Manager
OTC Medicines Evaluation
Office of Medicines Authorisation
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
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DRAFT Australian Regulatory Guidelines for OTe Medicines (ARGOM) Consultation
Thank you for the opportunity to comment on the DRAFT Australian Regulatory Guidelines for OTC
Medicines (ARGOM)
I will restrict my comments to one section, Section 8.1 of Appendix 2 ofthe guidelines relating to
measuring devices or dose delivery devices supplied with OTC products.
The authors of the DRAFT guidelines infers that measuring devices such as spoons, cups, applicators, etc
supplied with OTC medicines are' •.•• Captured by the TherapeuticGoods (Articles that are not medical
devices) Order No 1 of 2010' and can be evaluated by the TGA as part of the medicine.'
This is not the case, and it was never considered the Order would include such devices when it was
initially drawn up in February 2004 at the direction of the, then, Office of Devices Blood & Tissues
(ODBT). When drafted, the Order was intended, using Section 41BD(3) of the Therapeutic Goods Act, to
exclude 'an article that is intended to administer a medicine in such a way that the medicine and the
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article form a single integral product which is intended exclUSively for use in the given combination and
which is not fe-useable (may be mUlti-dose'
Within this phrase the words '... single integral product ... ' have significant meaning. This part of the
Order was only ever intended to exclude articles which could be considered medical devices such as
syringes prefilled with a medicinal component or non-refillable, but multi-dose insulin, growth hormone,
etc injectors containing multiple doses, but which were discarded when empty and not re-filled •••.
hence the phrase ~ ... single integral product.' The intent was to continue to treat these articles as
medicine containers, as had been done in the past. However, in treating them as containers, there
was/is still a requirement that the medical devices elements of their function, such as dose delivery, etc
comply with the relevant elements of the medical devices regulatory framework.
Examination of correspondence between the ODBT and the Legal Services Section and the relevant
medicine regulatory branches within the TGA, at that time, will confirm this.
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Measuring spoons, cups, applicators supplied with medicines are not single integral products. They may
be contained within the same consumer packaging, but they are physically separate from each other.
To take the approach outlined in the DRAFT will put the TGA at odds with the medical device regulatory
agencies of our major trading partners.
To treat these medical devices as suggested introduces confusion when pharmaceutical companies
supply 'extra' quantities of things such things as spoons, cups, etc to pharmacies to have on hand to
replace those lost/broken by patients, or in some instances supplied direct by the company to the
patient. These, clearly, are not what the authors of ARGOM consider integral to the product .... so what
is their status under the Act.
What also, is the status of measuring spoons, cups, applicators supplied separate to a medicine, and
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intended for keeping in the medicine cupboard, first aid kit, etc for use when required, with any
medicine. Presumably, given the wording of the DRAFT, these will continue to be regulated as medical
devices. The authors should note, however, it is not uncommon for these same devices to be supplied both for with a medicine, and independently by third party pharmaceutical product wholesalers. Do
they carry a different status depending on presentation ... the DRAFT guidelines would suggest this may
be so.
Further, this guidance does not consider other combinations of medical devices sometimes supplied
with medicinal products. What becomes the status of•
Medicinal delivery deviees which are not covered by the definition of a medical device with a
measuring function, such as a spoon like device, where the dosage instructions are along the
lines of '.•.• take one spoonful .......';
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•
Applicator pads, which by and large are not measuring devices;
•
Sterile syringes, needles and mixing cannula supplied with a presentation of Iypholised medicine
and a diluent where at least some of the needles and cannula are used to mix up the medicine
prior to administration with the supplied syringe and needle.
Are these to be treated differently, and outside the guidelines enunciated in this DRAFT, because they
have no measuring function ....... what is needed is consistency in regulation, not confusion.
The devices cited in this DRAFT are considered within the definition of a medical device outlined in
Section 41BD ofthe Act and are generally class I medical devices that may also be supplied sterile in
some instances. Some of the other examples cited in this letter are Class lIa medieal devices which may
also be supplied sterile and fall within the regulatory framework for medical devices.
It must also be noted the medical devices regulatory framework places a much more rigorous set of
regulatory requirements on the metrology aspects and accuracy of delivery ofthe medicinal component
than the cited EU PPharmacopoeia reference 2.9.27 - Uniformity of mass of delivered doses from
multidose containers.
When regulated as a medical device, these articles, and metrological aspects their design must be
independently assessed, verified and certified by a third party organization, independent ofthe
manufacturer. To consider them as excluded from the medical devices regulatory framework, removes
the need for this assessment and can, in some instances, potentially impact on safe delivery of the
medicine and compromise patient safety.
Again, thank you for the opportunity to comment on the DRAFT. I would be happy to answer any
queries you may have in relation to this submission.
Yours sincerely
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Principal
Locus Consulting Pty Ltd
9 February 2012
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