Substances that may require child-resistent packages

Monday, June 11, 2018

The Swedish Medical Products Agency has prepared a list of substances used in medicines where the observation or treatment in hospital of a child is warranted after intake of a limited amount (e.g. a single tablet). For medicinal products containing these substances the Swedish Medical Products Agency may require a child-resistant package, unless it can be considered that the pharmaceutical dosage form or the formulation itself reduces the risk.

This list is not exhaustive and the Swedish Medical Products Agency may also for medicinal products containing other substances require a child-resistant package where appropriate. The list is based on i.e. the experience of real incidences collected by the Swedish Poison Information Centre as well as assessments of the general properties of substances.

To prevent children from accidentally being exposed to medicines, the general principle is that medicines should be kept out of their sight and reach. Nevertheless, there is reason with respect to certain medicines to further limit childrens access by packing these medicines in more protective packages such as blister packs or containers/bottles with child-resistant closures.

It should be noted that also other substances than those on this list may constitute a serious risk to children.


Please note the news item’s date of publishing. The Swedish Medical Products Agency does not update news.


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