During ongoing shortages, the BfArM is in constant contact with the marketing authorization holders and the affected medical societies in order to determine mitigation measures. As a result exemptions can be granted or therapy recommendations can be published. Historical recommendations on enclosed shortages are collected in the archive (in German only).

Additional Information on specific APIs in shortage

The BfArM has various legal measures at its disposal to mitigate supply shortages which, under certain circumstances, allow medicinal products that do not conform to the marketing authorisation to be placed on the market in Germany.

These measures include Sections 10 sub-section 1a and section 11 sub-section 1c Medicinal Products Act (AMG), which allows the BfArM, as the competent higher federal authority to permit the marketing of medicinal products with labelling in languages other than german in the event of an impending or existing supply shortage. The prerequisite is that the medicinal products are used directly by the doctor on the patient.

In addition, the Supply Assurance for Medical Needs Ordinance (Medizinischer Bedarf Versorgungssicherstellungsverordnung, MedBVSV). permits the placing on the market of medicinal products

• Without labelling and package leaflet (section 4 subsection 1 MedBVSV),
• Whose expiry date has passed (section 4 subsection 2 MedBVSV) and
• Which have not been produced in accordance with the approved marketing authorisation documents (section 4 subsection 5 MedBVSV).

The prerequisites are that the measures are necessary to ensure the provision of care and that the benefit of the measure exceeds the possible risks. For this purpose, a benefit-risk analysis is carried out upon receipt of the application.

For further information and insights into the granted permissions please visit the corresponding page in German.

Recommendations with the aim of improving the delivery excellence of relevant medicinal products in hospitals

In view of recurring supply-relevant shortages in hospitals, the Jour Fixe on Delivery and Supply Shortages worked out a recommendation on how the robustness of supply excellence for hospitals can be better taken into account in the context of contract design between the pharmaceutical industry and pharmacy operators. This includes, among other things, reliable purchase forecasts and pricing taking into account the guaranteed supply capability of the products, transparency with regard to production conditions and storage capacities and binding commitments, e.g. for production and stockpiling.

The recommendation was confirmed at the 10th meeting of the Jour Fixe on Delivery and Supply Shortages on 11.07.2019 by all participants.