French Public Health Code
In forceI.-Pharmacists may only dispense a medicinal product or product other than that which has been prescribed, or which has a non-proprietary name other than the prescribed non-proprietary name, with the express prior agreement of the prescriber, except in an emergency and in the interests of the patient.
II - If the prescription under a non-proprietary name can be fulfilled by dispensing a medicinal product included in a generic or hybrid group mentioned in 5° of Article L. 5121-1, the pharmacist will dispense a medicinal product belonging to this group in accordance with the provisions of Article L. 162-16 of the Social Security Code.
By way of derogation from I, they may dispense a medicinal product from the same generic group or the same hybrid group by substitution for the medicinal product prescribed, provided that the prescriber has not excluded this possibility by expressly stating the reasons on the prescription. An order issued by the Ministers for Health and Social Security, after consulting the Agence nationale de sécurité du médicament et des produits de santé, specifies the medical situations in which this exclusion may be justified, in particular on the prescription, as well as, where applicable, the procedures for presenting this justification by the prescriber. Some of these medical situations may also be excluded from substitution by the pharmacist, even when the prescriber has not excluded this possibility on the prescription. The order referred to in this paragraph may also specify the medical situations in which this exclusion may be justified by the pharmacist, in particular on the prescription, as well as, where applicable, the procedures for presenting this justification by the pharmacist and for informing the prescriber. For medicinal products appearing on one of the lists mentioned in the first and second paragraphs of article L. 162-17 of the Social Security Code, this substitution is carried out under the conditions provided for in article L. 162-16 of the same code.
An order issued by the Ministers for Health and Social Security specifies, after obtaining the opinion of the Agence nationale de sécurité du médicament et des produits de santé, the medical situations in which substitution may be made by the pharmacist within a hybrid group.
III - When the pharmacist substitutes a medicinal product from the same generic group or the same hybrid group for the medicinal product prescribed, he must enter the name of the medicinal product he has dispensed. The same applies when the pharmacist dispenses a medicinal product on the basis of a prescription written in a non-proprietary name.
Prescription under a non-proprietary name is compulsory for medicinal products included in a generic group mentioned in 5° of article L. 5121-1.
IV -When a treatment is prescribed for a period of at least three months, including by means of a multiple renewal of a monthly treatment, and a large pack is available for the medicinal product concerned or for its generic form, the pharmacist must dispense the said pack.
V.- By way of derogation from I, in the event of a stock shortage of a medicinal product of major therapeutic interest mentioned on the list provided for in Article L. 5121-30, the pharmacist may replace the medicinal product prescribed by another medicinal product in accordance with the recommendation drawn up, after consultation with healthcare professionals and approved healthcare user associations, by the Agence nationale de sécurité du médicament et des produits de santé and published on its website. The Agency shall inform the Ministers for Health and Social Security without delay of the publication of each recommendation.
When the pharmacist replaces the medicinal product prescribed under the conditions set out in the first paragraph of this V, he shall enter the name of the medicinal product he has dispensed on the prescription and inform the prescriber of this replacement.
