Subsection 6: Unit dispensing of medicinal products in dispensing pharmacies

The specific arrangements for packaging, labelling and information for the insured party, as well as traceability for medicinal products dispensed individually in dispensing pharmacies, are set out in this subsection.

The list drawn up by the order provided for in article L. 5123-8 of medicinal products which may be dispensed by the unit is established by reference to the medicinal product or the pharmaco-therapeutic class to which it belongs.

Single units of medicinal products may be dispensed, subject to their inclusion on the list established by the order provided for in Article L. 5123-8, for medicinal products which comply with the following packaging rules: 1° Either the medicinal product is presented in the form of a blister pack containing at least the information provided for in Article R. 5121-141, in outer packaging that complies with the provisions of Article…

The pharmacist removes the prescribed dosage units from the original outer packaging by any means that guarantees their integrity. He or she places them in a new outer packaging suitable for transport and storage. All parts of the new outer packaging must be strong enough to prevent any loss of contents. The new outer packaging must not contain medicinal products from different batches.

Without prejudice to the case where the number of units prescribed corresponds to the number of units appearing in an initial outer packaging that complies with the provisions of article R. 5121-138, when the pharmacist dispenses the last units appearing therein, they are, by way of derogation from article R. 5132-42-4, given to the patient in this packaging. Medicinal products dispensed to blind or partially-sighted patients may only be dispensed…

By way of derogation from Article R. 5121-138, the label, printed by the pharmacist at the time of dispensing and affixed to the new outer packaging referred to in Article R. 5132-42-4, shall bear the following information, written in such a way as to be easily legible, clearly understandable and indelible: 1° The name of the proprietary medicinal product, the strength and the pharmaceutical form ; 2° Where appropriate, a…

When dispensing a medicinal product by unit, the pharmacist provides the patient with a printed version of the package leaflet referred to in Article R. 5121-148. By way of derogation from the previous paragraph, he may, subject to the patient’s agreement, inform the patient by any means of the arrangements for access to the electronic version of the package leaflet for the medicinal product in question.