French Public Health Code
In forceBy way of derogation from I of article L. 5125-23, the pharmacist may dispense, by way of substitution for the biological medicinal product prescribed, a similar biological medicinal product where the following conditions are met:
1° The similar biological medicinal product dispensed belongs to the same similar biological group, within the meaning of b of 15° of article L. 5121-1, as the biological medicinal product prescribed;
2° This similar biological group appears on a list, accompanied, where applicable, by conditions for substitution and information for the prescriber and patient on the occasion of this substitution to ensure continuity of treatment with the same medicinal product, set by a joint order of the ministers responsible for health and social security issued after consultation with the Agence nationale de sécurité du médicament et des produits de santé ;
3° Where they exist, the conditions mentioned in 2° of this article may be met;
4° The prescriber has not excluded the possibility of this substitution by expressly stating this on the prescription, in view of the patient's medical situation;
5° If the medicine prescribed is on the list mentioned in the first paragraph of article L. 162-17 of the Social Security Code, this substitution is made under the conditions set out in article L. 162-16 of the same code.
When the pharmacist substitutes a similar biological medicinal product from the same group for the biological medicinal product prescribed, he/she will write the name of the medicinal product he/she has dispensed on the prescription and inform the prescriber and the patient of this substitution.
Where a large pack is available for the similar biological form of the medicinal product and the treatment is prescribed for a period of at least three months, including multiple renewals of a monthly treatment, the pharmacist will dispense a large pack.
Article L5125-23-2
French Public Health CodeIn force
Updated 6 Nov 2023
