In January 2022, the BfArM was informed of the restricted availability of medicinal products containing tamoxifen via the supply shortage online portal to an extent that led to an immediate criticality check. The active substance tamoxifen is part of the list of active substances relevant to supply. Medicinal products with this active ingredient whose market share is 25 percent or more are subject to the voluntary notification obligation.

The evaluation of the supply situation showed that an imminent critical supply situation must be assumed. Without compensatory measures, a supply gap would be expected by the of February 2022 at the latest. Therefore, the BfArM informed the Advisory Council for Delivery and Supply Shortages according to Section 52b subsection 3b of the Medicinal Products Act (AMG). At the meeting on 9 February 2022, the Advisory Council for Delivery and Supply Shortages according to Section 52b subsection 3b of the Medicinal Products Act (AMG) unanimously decided on various measures to mitigate the supply shortages of medicinal products containing tamoxifen. These short- and long-term measures are intended on the one hand to ensure the supply of patients who depend on medicinal products containing tamoxifen and on the other hand to create security with regard to reimbursement.

Advisory Council, BfArM, BMG and all other stakeholders pursue the objective that with the announcement pursuant to Section 79 subsection 5 AMG, a demand-oriented prescription behaviour and further measures that are being coordinated (e.g. early production), the supply shortage that would be expected without compensatory measures by end of February 2022 at the latest can be avoided until the newly produced medicinal products are available to patients.

Based on the findings of the BfArM, the Federal Ministry of Health will announce the supply shortage in accordance with Section 79 subsection 5 of the Medicinal Products Act (AMG) by 18 February 2022 the competent supervisory authorities of the federal states. The details of the imported medicinal products are published on this BfArM website.

The causes of this supply shortage are manifold and require differentiated consideration. A singular deficit as a cause is not proven, but interactions of various effects occurred that led to the present critical supply situation. The complex and time-consuming manufacturing process of medicinal products with the active ingredient tamoxifen requires a lead time of several weeks in order to carry out further production. Nevertheless, the early production of further batches was initiated by the company, which means that new availabilities can be expected by end of April 2022.

The BfArM is in a continuous exchange with all stakeholders in order to comprehensively identify all options to reduce / compensate for an impending supply shortage, assesses all aspects and advocates a pragmatic approach with all stakeholders. Further developments and information are published on the BfArM website in German language.