Production of solutions for haemofiltration
The Medical Products Agency's regulations on the online production and handling of substitution solutions (dialysis regulations)
The regulations contain proposals for rules on the online production and handling of substitution solutions. Online production is carried out in healthcare in relation to dialysis treatment of patients through haemofiltration and haemodiafiltration. National rules apply the Medicines Act (2015:315) to pre-prepared substitution solutions (see Chapter 1, § 4 of the Medical Products Agency's regulations (LVFS 2011:15) on the application of the Medicinal Products Act (2015:315) to certain products). See also the impact assessment.
It is proposed that the regulation be adopted no sooner than September 2020.