Agency for Medicines of BiH on the use of medical oxygen in health centers

(Patria) - The Agency for Medicines and Medical Devices of Bosnia and Herzegovina addressed the public with a statement regarding inquiries about the inability to use the drug medical oxygen in health centers as primary healthcare institutions due to the approved dispensing regime ZU/Rp, and they emphasized that ZU/Rp drugs are used in secondary or tertiary healthcare institutions and are dispensed by prescription for the needs of continued hospital treatment.

"For the drug medical oxygen (cylinder packaging), the dispensing regime ZU/Rp was approved in the marketing authorization procedure. The aforementioned dispensing regime is in accordance with Article 4, Paragraph 2, Point c) of the Rulebook on the method and procedure for classifying medicines, hereinafter referred to as the Rulebook", they state in the announcement.

As they emphasize, the Rulebook states the following for the aforementioned dispensing regime ZU/Rp:

"ZU/Rp (the drug is used in a secondary or tertiary healthcare institution; exceptionally dispensed by prescription for the needs of continued hospital treatment): the drug is used for the treatment of a disease that must be diagnosed in a hospital or in an institution with adequate diagnostic facilities; the use of the drug in continued treatment, as well as the monitoring of treatment itself, can be carried out outside a secondary or tertiary healthcare institution".

They also added that the Commission for Medicines, at its urgent extraordinary session yesterday, reviewed once again the approved dispensing regime for the drug medical oxygen in cylinders, manufactured by Messer BH.

"After discussion, it was unanimously concluded that the approved dispensing regime ZU/Rp for the drug in question is in accordance with the Rulebook, and that the use of the drug outside a secondary or tertiary healthcare institution is also covered by it. In accordance with all of the above, it is concluded that the drug with the approved dispensing regime ZU/Rp can also be used in a healthcare institution that does not belong to the secondary and tertiary level of healthcare", stated the Agency for Medicines and Medical Devices of BiH in the announcement.