The procedures and standard form for the declarations and report mentioned in Articles R. 5121-174 to R. 5121-176 are laid down by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
This sub-section applies to post-authorisation safety studies of a non-interventional nature within the meaning of Article R. 1121-2, which give rise to the collection of safety information from patients or healthcare professionals. These studies are carried out under the responsibility of the marketing authorisation holder referred to in article L. 5121-8, who is responsible for their management and checks that they are properly funded. These studies may also be carried…
This article applies to the post-authorisation safety studies referred to in Article R. 5121-178 which are carried out either voluntarily by the holder of the marketing authorisation referred to in Article L. 5121-8, or at the request of the competent national authorities, or in order to comply with an obligation imposed pursuant to Articles R. 5121-36-1 and R. 5121-37-3. The Director General of the Agence nationale de sécurité du médicament…
I.-This article applies to the post-authorisation studies referred to in article R. 5121-178 which are carried out by the holder of the authorisation referred to in article L. 5121-8 in order to comply with an obligation imposed pursuant to articles R. 5121-36-1 and R. 5121-37-3. II – Before conducting a study, the holder of the authorisation provided for in Article L. 5121-8 submits a draft protocol to the Pharmacovigilance Risk…
A decision by the Director General of the Agence nationale de sécurité du médicament et des produits de santé defines the principles of good pharmacovigilance practice. This decision also sets out the procedures for collecting, verifying and evaluating the information mentioned in Article R. 5121-151. It is published on the Agency’s website.
In health establishments and health cooperation groups with an in-house pharmacy, the pharmacist managing this pharmacy is the correspondent of the regional pharmacovigilance centre for blood-derived medicinal products. When an establishment has several internal-use pharmacies, the pharmacist managing each of these pharmacies is the correspondent of the regional centre for the blood-derived medicinal products it supplies. In health establishments and health cooperation groups authorised under article L. 6133-7 to carry…
The pharmacovigilance correspondent for blood-derived medicinal products mentioned in article R. 5121-181 is responsible within the establishment for dispensing and monitoring these medicinal products. In health establishments, he/she takes part in the work of the transfusion safety and haemovigilance committee or the sub-committee responsible for transfusion safety and haemovigilance, under the conditions set out in article R. 1221-46 . It is responsible for recording and storing information relating to blood-derived…
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…
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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