#SFHS2609375AOrder of April 10, 2026, amending the Order of February 20, 2025, setting the list of substitutable similar biological groups by pharmacists
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This law updates the list of biological medicine groups that pharmacists in France can substitute with similar biologicals. It sets guidelines on how pharmacists should inform patients and prescribers about the substitution, including recording details for traceability. The law affects pharmacists, patients, and healthcare providers dealing with biological medicines.
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Key Changes
- Expanded list of substitutable biological medicine groups
- Guidelines for pharmacist-patient communication during substitution
- Traceability requirements for substituted medicines
Obligations
What this law requires
Pharmacists must inform patients at the time of dispensation when a biological medicine substitution occurs and provide associated useful information including storage rules for the dispensed product
Pharmacists must record the name of the biological medicine actually dispensed by substitution and its batch number using appropriate means to ensure traceability of all biological medicines
Pharmacists must inform the prescriber of which biological medicine was actually dispensed to the patient
Pharmacists must mention on the prescription the name of the biological medicine actually dispensed by substitution
Pharmacists must ensure continuity of dispensation of the same biological medicine in subsequent dispensations unless the patient requests to return to the originally prescribed specialty