Paragraph 2: Monitoring of blood-derived medicinal products

When a healthcare professional administers a blood-derived medicinal product outside healthcare establishments or the establishments and organisations mentioned in article R. 5121-192, he/she affixes a detachable label from the immediate packaging of the unit administered to the original prescription kept by the patient. When the medicinal product is administered by a doctor, the latter affixes the other detachable label of the immediate packaging of the unit administered to the medical…

The formalities of transcribing, recording and drawing up the forms provided for in this paragraph take the place of the transcriptions and recordings mentioned in article R. 5132-10.

The registers or records provided for in articles R. 5121-185 to R. 5121-193 are kept for a period of forty years. Where necessary for the purposes of pharmacovigilance, the regional pharmacovigilance centres have access to these documents.