Directive on the direct dispensing of medicinal products to patients in the context of clinical trials

Due to the coronavirus problem and potentially overloaded hospitals, it may be difficult or undesirable for a patient participating in a clinical trial to obtain their investigational medicinal product (IMP) at the hospital. The FAMHP provides guidelines on this subject.

If a patient cannot access the hospital, or if it is not desirable that they do so in the current situation, it is permitted to send the investigational medicinal products (IMP) directly to the patient. This will be the responsibility of the principal investigator in accordance with national and international legislation.

The promoter of a clinical trial may not intervene in this process for reasons of confidentiality and integrity. Of course the appropriate sending conditions must be respected. This process must be documented and entirely traceable.

Last updated on
24/03/2020