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Packaging of medicine and the safety of our

children

Experiences with legislation in Germany

Brussels

23.09.2004Dr. Axel Thiele

thiele@bfarm.de

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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.

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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/stufenpl/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 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.

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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.