Section 13: Pharmacovigilance

Pharmacovigilance of blood-derived medicinal products involves monitoring, known as traceability, from the time they are manufactured until they are administered to patients. The purpose of this monitoring is, in particular, to enable rapid identification of : 1° The blood samples from which a given batch of medicinal products was manufactured, and the batches of medicinal products manufactured from given blood samples; 2° The batches from which the medicinal products administered…

Without prejudice to the obligations laid down in Articles R. 5121-138 to R. 5121-142, the packaging of a blood-derived medicinal product includes three detachable labels, separate from the information medium mentioned in Article L. 161-36 of the Social Security Code and indicating the name, strength and pharmaceutical form of the medicinal product, the name of the company or organisation operating it and the batch number. These labels also bear a…

A pharmaceutical establishment manufacturing, operating, importing, exporting or wholesaling blood-derived medicinal products must, when disposing of these medicinal products, record : 1° The name, strength and pharmaceutical form of the medicinal product concerned ; 2° The batch number and the number of units supplied; 3° The date of the disposal operation; 4° The name and address of the recipient(s). Establishments which manufacture blood-derived medicinal products also record data enabling the…

Dispensing pharmacists who dispense a blood-derived medicinal product must immediately transcribe the information mentioned in article R. 5132-10, the patient’s date of birth and the information appearing on the detachable label of the outer packaging onto a special register, which must be listed and initialled by the mayor or the police commissioner, or record it immediately using any system approved by the Minister for Health. If a transcription is made…

In healthcare establishments and other establishments with an in-house pharmacy, blood-derived medicinal products are dispensed by the in-house pharmacy on the basis of a medical prescription. The in-house pharmacy attaches to the medicinal product a numbered slip, known as a dispensing and administration slip, on which it records the following information: 1° The name of the prescriber and the department to which he belongs ; 2° The surname, first names…

In the establishments referred to in Article R. 5121-187, the person administering the blood-derived medicinal product to the patient completes the dispensing and administration slip with the following information: 1° The patient’s surname, forenames and date of birth ; 2° The date of administration; 3° The dose administered. It mentions the dose administered and the date of administration on the prescription kept in the medical record and affixes a label…

When the in-house pharmacy dispenses a blood-derived medicinal product directly to a patient, the information referred to in article R. 5121-187 is transcribed onto a special register marked and initialled by the mayor or police commissioner, or recorded by any system approved by the Minister for Health.

Exceptionally, after consultation with the managing pharmacist, by decision of the director of the health establishment or the administrator of the Groupement de Coopération Sanitaire, departments may have a supply of blood-derived medicinal products intended for urgent care. This supply is managed in accordance with the provisions of the order provided for in article R. 5132-42. When a medicinal product is taken from the supply provided for in the previous…

In health establishments and health cooperation groups authorised under article L. 6133-7 to carry out the tasks of these establishments which do not have an in-house pharmacy which hold blood-derived medicinal products under the conditions mentioned in article L. 5126-6, the supply of blood-derived medicinal products gives rise to the recording by the correspondent mentioned in article R. 5121-181, in a special register marked and initialled by the mayor or…