A new draft monograph, Oxygen (98 per cent) (3098), has been published for comment in this quarter’s issue of Pharmeuropa (33.4), the European Pharmacopoeia (Ph. Eur.) online forum. The deadline for comments on the new monograph is 31 December 2021.
This draft monograph is the outcome of a thorough examination of the substantial response to the request for feedback issued in April 2020 and which prompted lively and constructive discussions with regulatory experts in the field, as well as a series of dedicated Ph. Eur. expert meetings.
The input representing different standpoints from a diverse range of stakeholders, including regulators, hospital pharmacists, industry representatives (gas producers and producers of oxygen generating equipment) and academics, allowed participants to approach the topic with the highest level of expertise. Contributions from all users and interested parties via Pharmeuropa on Ph. Eur. texts published for consultation is of fundamental importance to maintaining the Ph. Eur. – which is a legal standard in Europe – up-to-date and fit for purpose.
Comments from within the Ph. Eur. member states are to be sent to the relevant national pharmacopoeia authority; comments from other countries or from industry associations may be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk. For more information on how to comment, please consult our guide.
- Related news items: “Oxygen 98 per cent: Ph. Eur. requests feedback on new oxygen quality to boost availability” (16 April 2020) and “Oxygen 98 per cent: Ph. Eur. receives valuable feedback on new oxygen quality” (15 June 2020)
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