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| home > pmps > winter 2001 > progress towards child-resistant flexible packs for pharmaceuticals in the uk and the rest of european union |
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Pharmaceutical Manufacturing and Packing Sourcer
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Child-resistant (CR) packaging emerged in the US with the introduction of the Poisons Prevention Packaging Act of 1970. The 1975 Medicines (Child Safety) Regulations in the UK specified child-resistant packaging for some pharmaceuticals, initially solid dose children's aspirin and paracetamol and subsequently, adult versions of these drugs. The UK was the first European Union (EU) country to utilise CR packaging and the second country after the US.
Even today, standards for CR packaging and a legal duty to use the product exist only in the US, Canada, New Zealand, Australia, the UK, Germany and Italy.
The definitive test for child resistance is a protocol test where a sample of up to 200 children is used and asked to simply open the pack being tested. The sample is allowed two sessions; five minutes, then a silent demonstration, then a further five minutes. The pack fails (that is, it is not considered child-resistant) if 15 per cent of the sample open it prior to demonstration, or 20 per cent open it post-demonstration.
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