Relevant regulations

The mixture of 50% nitrous oxide and 50% oxygen, available by the trade name of ENTONOX, has become an important part of modern medicine.

To ensure that its usage is optimised and patients receive the highest level of safety, quality and efficacy, ENTONOX is handled, prescribed and administered with the same precision and care as any other pharmaceutical. Hence, BOC Healthcare complies with the strict requirements and standards for the manufacture and quality control of pharmaceutical gases stipulated by the appropriate regulatory bodies.

Documentation of pre-clinical and clinical aspects 

In documenting the pre-clinical and clinical aspects of our medicinal gases, we have followed the pharmaceutical guidelines set by the International Conference of Harmonization (ICH).

In the case of traditional medicinal gases such as ENTONOX in analgesia, our documentation summarises existing, public domain, scientific literature according to guidelines set out by the MHRA (Medicines and Healthcare products Regulatory Agency).

Directives and quality system (QS) standards 

The following directives and QS standards are applicable for the manufacture, distribution and marketing of gases classified as a medicinal product such as ENTONOX:

  • 2001/83/EC Directive. Amended by 2004/27/EC Directive
  • 75/318-319 EEC Regulatory
  • 2003/94/EC Directive. 91/356/EEC GMP (Good Manufacturing Practice)
  • 94/25/EEC GDP (Good Distribution Practice)
  • 2001/20/EC Directive and2005/28/EC Directive (Good Clinical Practice)
  • EC/726/2004 Regulation (Community procedures and EMEA)
  • European Pharmacopoeia

To learn more about the requirements and standards for the manufacture, distribution and marketing of pharmaceutical gases, please click the links to the relevant regulatory body websites and/or regional regulatory bodies in the right sidebar.

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