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Th/109/1
Packaging of medicine and the safety of our
children
Experiences with legislation in Germany
Brussels
23.09.2004Dr. Axel Thiele
Th/109/3
Legal Basis
German Drug Law
§ 28, Sub-Section 2 No. 5
The conditions specified in sub-section 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.
Th/109/4
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/stufenpl/index.php)
Th/109/6
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
Th/109/10
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.
Th/109/11
DIN 55 559
A reclosable 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 within 10 minutes or, concerning the blister packages gain access to more than eight individual units within these 10 minutes.
Th/109/12
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.
Th/109/13
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.