The Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz (ALBVVG) was published on 26 July 2023 in the Federal Law Gazette (Bundesgesetzblatt). This law strengthens the responsibilities of the Federal Institute for Drugs and Medical Devices (BfArM) and its Advisory Council for Delivery and Supply Shortages (Beirat für Liefer- und Versorgungsengpässe) in the field of the continuous monitoring and evaluation of overall supply situation in Germany. Among other things, the Act requires the BfArM to establish a rapid alert system and identify imminent or existing supply-relevant market concentrations of off-patent medicines with APIs that are in a supply-critical state.

With the effective date of the law, 27 July 2023, the BfArM  has to publish a list of essential paediatric medicinal products, taking into account age-appropriate dosage forms and strengths for the treatment of children up to 12 years of age, after consulting the Advisory Council pursuant to Section 52b (3b) of the German Medicines Act (AMG). A list of essential paediatric medicines has been developed in collaboration with paediatric specialist associations, specialist departments of the BfArM and representatives of the Advisory Council. The first version of the list is available below:

The list is updated monthly and published on the German BfArM Homepage in the section supply shortages. To view the latest version, see the German webpage: Arzneimittel-Liefer­eng­pass­bekämpfungs- und Versorgungsverbesserungsgesetz.

As a part of the strategy to prevent shortages, the BfArM together with the Advisory Council develops recommendations and evaluates therapeutic alternatives to improve the supply of drugs for human use. For the infection season 2023/2024, the BfArM in consultation with the Federal Ministry of Health (BMG), has drawn up a priority list of paediatric medicines that may be subject to supply shortages. That list is now part of the German law which means that if a medicinal product on the list that is to be dispensed in accordance with valid regulation is not available, pharmacies can exchange it for a medicinal product manufactured in the pharmacy with the same active ingredient, even in a different dosage form, or for a finished medicinal product with the same active ingredient in a different dosage form without consulting the prescribing doctor. The list is regularly updated and published on the German BfArM Homepage in the section supply shortages. The first version of it can also be found below:

Further information on the German Act to Combat and Improve the Supply of Medicines (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz, ALBVVG) can be found on the website of the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG).