Requirement of a manufacturing authorization under pharmaceutical law for autologous fat transplantation

It has been disputed for some time whether a doctor requires a manufacturing authorization under pharmaceutical law for an autologous fat transplant that he performs in his practice.

The Lüneburg Higher Administrative Court has now ruled for the first time in a main case that a doctor who takes autologous fat from his patient - for example from the thigh - centrifuges it and then injects it into the finger joint as "synovial fluid" to treat rhizarthrosis requires a manufacturing authorization under pharmaceutical law. In principle, manufacturing for the purpose of personal use in a specific patient is not permitted, as the doctor is manufacturing an advanced therapy medicinal product (ATMP) during this process (Section 13 para. 2b AMG).

The Higher Administrative Court of Lüneburg has now ruled for the first time in a main case that a doctor who takes autologous fat from a patient - for example from the thigh - centrifuges it and then injects it into the finger joint as "synovial fluid" to treat rhizarthrosis requires a manufacturing authorization under pharmaceutical law. In principle, manufacturing for the purpose of personal use in a specific patient is not permitted, as the doctor is manufacturing an advanced therapy medicinal product (ATMP) during this process (Section 13 para. 2b AMG).

Our colleague Dr. Christoph Renz deals with this ruling in a specialist article for the juris PraxisReport and outlines possible counterarguments against the legal opinion of the OVG Lüneburg. From his point of view, the judgment has weak points in key areas.

You can find the link to the review of the judgment here.

Status: 02.10.2023