Transcript Kein Folientitel

Packaging of medicine
and the safety of our
children
Experiences with
legislation in Germany
Brussels
23.09.2004
Dr. Axel Thiele
[email protected]
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Legal Basis
German Drug Law
§ 28, Sub-Section 2 No. 5
The conditions specified in subsection 1 may be imposed in order
to ensure that the drug is marketed
in a container of a particular form
with a specific seal or some other
kind of safety measure, in so far as
it is deemed necessary to
guarantee compliance with the
dosage instructions or to prevent
the danger of misuse by children.
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Decisions BGA
Anordnung einer Auflage nach § 28
Arzneimittelgesetz (Kindergesicherte
Verpackungen für Arzneimittel) vom
18. April 1979,
12. Februar 1982 und
17. September 1984
(http://www.bfarm.de/de/Arzneimittel/am_sicher/st
ufenpl/index.php)
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Concerned
substances
Analgesics
Antirheumatics
Barbiturates
Opioids
Antipsychotics
Iron
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Exceptions
Drugs with an effervescent
effect
Hospital packages
Homoeopathic drugs
Single sachets containing
powder or granulate
Fluids with drop inserts
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Kinds of packages
Reclosable
Press or Push and Turn
Squeeze and Turn
Lug Closure
Snap Closure
Others
Non-reclosable
Blister
Strip Package
Peel Push Package
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PPPA
A package is considered to
have failed the test if the
children open or gain access
to the number of individual
units which constitute the
amount that may produce
serious personal injury or
serious illness or to more
than 8 individual units,
whichever number is lower.
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DIN 55 559
A reclosable package is considered t
have failed the test if the children open o
gain access to the number of individua
units which constitute the amount tha
may produce serious personal injury o
serious illness within 10 minutes o
concerning the blister packages gai
access to more than eight individual unit
within these 10 minutes.
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EN 14375 (1)
Note
The figure of eight units is based on
existing national standards published
by certain CEN members and does
not address the issue of toxicity.
Some pharmaceutical products on
the market can cause harm to
children by the ingestion of fewer
than eight units. However, reliable
data on child toxicity exists for few
pharmaceutical products. A harmful
dose can be established for some
existing pharmaceutical products and
a maximum safe dose can be
established for all pharmaceutical
products by one means or another.
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EN 14375 (2)
Such information is not currently
available for all products and there
is no central register where this
information could be held. In the
absence of European legislation on
this topic the drafters of this
European Standard acknowledge
these concerns and believe that
research and collection of data
should continue with a view to
considering the substitution of a
toxicity based pass/fail criterion for
the child panel test in a later
revision.
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