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|
|*PL18813/0001||Anapen 300 micrograms|
|*PL18813/0002||Anapen Junior 150 micrograms|
|*PL18813/0003||Anapen 500 micrograms|
|0735/5000||Medical Oxygen (compressed)|
|0735/0009||Medical Oxygen (liquid)|
|0735/5001||Medical Nitrous Oxide|
|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|
|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 Lincoln Medical Ltd, please call 01748 828 785. **Available from BOC Special Products, please call 0800 020 800