04 EIGA actively contributes to WHO and EMA initatives
EIGA is on the WHO generic mailing list for quality assurance of medicines working documents and scientific monographs. The MGC has already commented on several new WHO documents, covering medical oxygen PSA's and Good Manufacturing Practices for medical gases.
The EMA, European Medicines Agency is preparing a new revision of the Directive 2001/83/EC , which regulates the Marketing Authorisations of medicines. This directive is also important for our medicinal gases and EIGA has already responded to the EMA on their first public consultation on the principles of this directive, particularly on two aspects:
‘’Inefficiency and administrative burden of regulatory procedures’’ on which we refer to our COVID19 proposed regulatory flexibilities in our BN25/21, and
‘’Vulnerability of supply of medicines, quality, environmental challenges and sustainability’’, where we commented that our industry believes that there is currently not an equal level of legislative regulation for on-site manufacturing machines producing medical oxygen at healthcare facilities.
Doc 141/21 - Planning Oxygen Supplies for Respiratory Patients when Travelling
(revision of Doc 141/13) This document provides advice to the Homecare Service Provider about the minimum safety precautions to be given to a patient when they require to use medical oxygen supply systems outside the home environment and whilst travelling.
The advice can also be provided to the travel companies, such as airlines, train and bus operators and public services providers as a guideline for the safe use of medical oxygen supply system for domiciliary patients.
The document details the actions and roles in providing a suitable medical oxygen supply system for the:
It also includes specific guidelines for homecare respiratory patients for using oxygen when, in transit, at locations outside the home and when travelling away from home for longer periods.
Templates are included for leaflets to be provided to the patient, advising the minimum safety requirements for the use of medical oxygen supply systems in transit, and for the travel service provider, for the safe use of medical oxygen equipment in transit.
Also provided is information covering carrying and/or using medical oxygen systems on different forms of transport and in different public environments.
Advice is provided on the permissions required when using medical oxygen supply equipment on public transport and in public areas.
The document may be used by anyone involved in planning oxygen supplies for respiratory patients when travelling as well as by patients and those travelling with them.