British standard on child resistance

The UK Regulations implementing the use of British Standard 8404 on the child resistance of non-recloseable pharmaceutical packaging have now been published and came into force on 1 October for new products with a two-year transitional period for existing products.

As expected, they apply to products containing aspirin, paracetamol and iron. They also allow the use of materials meeting equivalent child resistance standards in other EU member states - for example the German DIN standard

The Regulations are supported by a guidance note for manufacturers which is on the MHRA's website and which contains a list of materials that are accepted as meeting such child-resistance requirements.

The regulations also consolidate requirements for recloseable pharmaceutical containers for the specified products with the same timescales as set out for non-recloseables and similar transitional periods.

There have also been developments on this topic in other regions. In the US, the Healthcare Compliance Packaging Council (HCPC) has petitioned for the opening criterion for non-recloseable pharmaceutical packaging to be defined as eight units as in BS 8404 and to allow type testing. This proposal was put out for consultation. The consultation period ended in August and the outcome is awaited.

In Europe, the draft CEN standard on non-recloseable pharmaceutical packaging has been voted upon and adopted and will go ahead to publication.

Obviously there will be an ongoing debate on the application of these Regulations and standards - and no doubt this column will return to the topic.