In spring 2022, the BfArM was informed of the limited availability of calcium folinate-containing medicinal products in parenteral administration via the supply shortage online portal.

Calcium folinate-containing medicinal products are mainly used in cytotoxic therapy for "calcium folinate rescue" to reduce the toxicity and effect of folic acid antagonists (such as methotrexate) in cancer therapy (cytotoxic therapy) or their overdose in adults and children, as well as for combination treatment with 5-fluorouracil in cancer therapy (cytotoxic therapy).

The active substance folinic acid, under which the active substance calcium folinate is to be evaluated, is named on the list of supply-critical active substances according to section 52b sub-section 3c of the Medicinal Products Act (AMG). Medicinal products containing calcium folinate thus meet the criteria for the voluntary obligation to report supply shortages. Hence, non-availabilities must be reported in the supply shortage online portal.

A criticality test of the BfArM for calcium folinate revealed a critical supply situation. As an immediate measure, overstock of calcium folinate-containing medicinal products abroad were identified in close exchange with the marketing authorisation holders concerned and placed on the market in Germany on the basis of exemptions granted pursuant to sections 10 sub-section 1a and 11 sub-section 1 AMG and § 4 sub-section 5 MedBVSV.

In the course of the supply-shortage monitoring, it was visible that supply-shortages were not fully compensated by the measures taken and that a stabilisation in the supply was not achieved. Furthermore, the data available to the BfArM on production, purchasing and dispensing of the medicinal products in question showed an uneven regional distribution of the remaining available stocks. In order to prevent this uneven distribution and to have goods that are still available as well as the goods expected in the 1st quarter of 2023 in line with demand, further temporary measures in the form of an order pursuant to section 52b sub-section 3d AMG were agreed in a special meeting of the Advisory Council for Delivery and Supply Shortages pursuant to section 52b subsection 3b AMG on November 30th 2022, which orders an exceptional restriction of the distribution channels and a quota-based dispensing.