Medical Gases Regulations & Classifications

Guidance on regulations & classifications and cylinder storage and handling for a safer workplace

Medical Gases Regulations & Classifications
Relevant regulations

Relevant regulations

Today medicinal gases are an important part of modern medicine. To ensure that their use is optimised and patients receive the highest level of safety, quality and efficacy, they should be handled, prescribed and administered with precision and care.

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.

Regulations and Classifications

You can depend on receiving top quality gases from BOC Healthcare. All our medical gases are fully compliant with MHRA requirements. Our manufacturing sites are audited by the MHRA Medicines Inspectorate every 2 years. In addition, our Quality Management System is also registered to ISO 9001:2015 (audited by Bureau Veritas).

European Directive 2001/83 is the prime legislation that covers the requirements for the manufacture and supply of medicinal products – which includes the full range of medical gases supplied by BOC Healthcare.

The regulations cover the requirements for licensing the products and defines the use of Good Manufacturing Practice (GMP) to control its manufacture. The regulations are designed to protect patient safety, ensuring that the products are safe, efficacious and of an appropriate quality level.

Medicinal products are classified when licensed to define the control required when supplying the patient, ranging from those products available ‘over the counter’ without a prescription, to those which can only be supplied to under prescription to a named patient.

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 oxygen, HELIOX21 ® or ENTONOX ® our documentation refers to publicly available scientific literature, in accordance with guidelines set out by the Medicines and Healthcare products Regulatory Agency (MHRA).

Directives and Quality Management Systems (QMS) standards

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

  • Human Medicines Regulations 2012 (as amended)
  • 2001/83/EC Directive. Amended by 2004/27/EC Directive
  • 2003/94/EC Directive. (Good Manufacturing Practice)
  • 536/2014 (EU Clinical Trial Regulation) and 2005/28/EC Directive (Good Clinical Practice)
  • EC/726/2004 Regulation (Community procedures and EMA)
  • 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 below.

Marketing authorisations

Marketing authorisations

BOC Healthcare are able to supply various Medical Mixtures via our specials licence. All medical products supplied by BOC are controlled by the MHRA, who issue Marketing Authorisations.

Under the UK’s Medicines Act (and the subsequent European legislation), the control of medicinal products for human use is controlled by the issue of Marketing Authorisations.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for issuing Marketing Authorisations. The MHRA reviews all licence applications to ensure that the medicinal gases are safe for patient use, efficacious, covering all of the proposed indications and manufactured to the appropriate levels of quality. Where applicable, the medical gases (and their component gases) comply with the relevant European Pharmacopoeia monograph.

Below is a list of all our medical gases and their corresponding authorisation numbers

Marketing Authorisation No Product Name
0735/5000 Medical Oxygen (compressed)
0735/0009 Medical Oxygen (liquid)
0735/5001 Medical Nitrous Oxide
0735/5002 Synthetic Medical Air
0735/5006 Medical Carbon Dioxide
0735/5010 5% Carbon Dioxide / Oxygen
0735/5017 Entonox 50% Oxygen / Nitrous Oxide
0735/5011 21% Oxygen / Helium
*0735/0014 10% Carbon Dioxide / Oxygen
*0735/0013 20% Carbon Dioxide / Oxygen
*0735/5014 5% Carbon Dioxide / Air
*0735/5015 9% Helium / 35% Oxygen / Nitrogen
*00735/5016 Lung Function mix 1
0.28% Carbon Monoxide / 14% Helium / 18%Oxygen / Nitrogen
*0735/0011 Lung Function mix 3
0.28% Carbon Monoxide / 9% Helium / 19% Oxygen / Nitrogen
*0735/0012 Lung Function Mixture 4
0.30% Carbon Monoxide / 10% Helium 21% Oxygen / Nitrogen

BOC Healthcare hold a Specials Licence which allows them to manufacture and supply medical gases that are not covered by a Marketing Authorisation.

Under this licence, BOC are able to produce any medical gas/ gas mixture specifically requested by doctors and pharmacists. As there are no Marketing Authorisations covering these products, the doctor takes the responsibility for the safety and efficacy of the products but BOC is responsible for the quality of the product.

BOC's Manufacturers Specials Licence Number is ML/0735

*Available from BOC Special Products, please call 0800 020 800

Pharmaceutical quality

Pharmaceutical quality

Medical gases are essential to modern medicine and should be considered, prescribed and administered with the same precision and care as any other pharmaceutical products.

The medicinal products supplied by BOC Healthcare are licensed for use by the Medicines and Healthcare products Regulatory Agency (MHRA) and satisfy the requirements stipulated by the European legislation. BOC were among the first companies to adopt these pharmaceutical standards for medical gases.

In addition to the requirements, for operating to a Quality Management System compliant with the requirements of the EC Good Manufacturing Practice (GMP) guide, the guidelines include detailed requirements for personnel, training, premises and equipment, documentation, production, quality control, storage and release (specifically detailed for medicinal gases through annex 6 of the general GMP guide).

Therefore, for all medical gases supplied, BOC Healthcare can offer to both patients and healthcare professionals a safe, reliable and simple application, meeting all the quality criteria of a registered pharmaceutical product.

Cylinder storage and handling

Cylinder storage and handling

Under the Health and Safety at Work Act 1974 and HTMO2 guidelines, it is the responsibility of employers to train their employees on the recommended safeguards relating to the handling of medical gases to ensure they understand and employ safe practices.

The basic safety guidance on this page is not intended as a substitute for the necessary comprehensive training that is required for portering staff, nurses and other personnel regularly involved in handling medical gases.

Medical gas cylinder handling and store design

HTM02 provides comprehensive guidance on the design and construction of medical gas cylinders stores.

Medical gas cylinders should be kept in a purpose built cylinder store that should allow the cylinders to be kept dry and in a clean condition. When designing the cylinder store a risk assessment should be carried out to ensure that the chosen location is as safe as is practicable and that any manual handling issues are engineered out at the planning stage.

In order to comply with current manual handling regulations and key requirements for a medical gas cylinder store, it is advisable that the following precautions are followed:

  • Allow cylinders to be stored under cover, preferably enclosed and not subjected to extremes of temperature
  • Be kept dry, clean and well ventilated (both top and bottom)
  • Have good access for delivery vehicles and reasonably level floor areas
  • Be large enough to allow for segregation of full and empty cylinders and permit separation of different medical gases within the store
  • Be totally separate from any non medical cylinder storage areas
  • Be sited away from storage areas containing highly flammable liquids and other combustible materials and any sources of heat or ignition
  • Have warning notices posted prohibiting smoking and naked lights within the vicinity of the store
  • Be secure enough to prevent theft and misuse

Medical gas cylinder store operation

The layout and racking within the medical gas cylinder store should;

  • Allow for strict stock rotation of full cylinders to enable the cylinders with the shortest expiry time to be used first
  • Allow large size cylinders (such as F, HX, ZX, G and J sizes) to be stored vertically on concrete floored pens
  • Allow small size cylinders (such as C, CD, D and E sizes) to be stored horizontally on shelves (made of a material that will not damage the surface of the cylinders)
  • Allow for all ENTONOX cylinders to be stored at above 10°C for 24 hours prior to use. (Where this is not feasible, it is important to consult the ENTONOX Medical Gas Data Sheet for further information before using the cylinders)
Advice should be sought from the local authorities regarding any specific regulations pertaining to the design and location of the cylinder store.

BOC can provide assistance with the appropriate warning signs required for cylinder stores. Additional information about the layout and operation of the store is available in HTM 02. The Emergency Services should be advised of the location and contents of the cylinder store.