French Public Health Code
In forceI.-A supply shortage is defined as the inability of a dispensing pharmacy or a pharmacy for internal use as defined in article L. 5126-1 to dispense a medicinal product to a patient within 72 hours, after having requested supplies from two companies engaged in the distribution of medicinal products as referred to in article R. 5124-2. This 72-hour period may be reduced at the pharmacist's initiative, depending on compatibility with the optimal continuation of the patient's treatment.
II. - This supply disruption may be attributable in particular to a stock shortage, which is defined as the impossibility of manufacturing or using a medicinal product. Marketing authorisation holders and pharmaceutical companies operating a medicinal product of major therapeutic interest referred to in Article L. 5111-4 must inform the Agence nationale de sécurité du médicament et des produits de santé of any risk of a stock shortage or any stock shortage of this medicinal product as soon as they are aware of it, in accordance with the reporting procedures and model laid down by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
III - The operating pharmaceutical establishments mentioned in 3° of article R. 5124-2 have permanent emergency call centres or any equivalent system allowing direct contact, which are accessible to dispensing pharmacists, pharmacists in pharmacies for internal use as defined in article L. 5126-1 and pharmacists responsible for or delegated by wholesaler-distributors. Operators shall take all necessary steps to make the call numbers or equivalent systems known to the aforementioned healthcare professionals. The operator shall ensure that calls and responses are traceable.
These centres are organised in such a way as to enable the missing speciality to be dispensed as soon as the supply shortage becomes effective or, in advance, when the shortage is confirmed by the wholesaler-distributor or the stockist. The traceability of emergency supplies is ensured under the conditions defined by Article R. 5124-58.
