The declarations and the periodic safety update report referred to in Articles R. 5121-161, R. 5121-168 and R. 5121-170 are drawn up in accordance with the procedures and standard form laid down by the European Commission.
The holder of the authorisation provided for in Article L. 4211-6 is required to report the following to the Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Any serious adverse reaction suspected to be due to the allergens he has prepared and supplied, of which he is aware, without delay and no later than fifteen days following receipt of the information; 2°…
Pharmaceutical establishments, including those managed by public health establishments mentioned in articles R. 5124-68 to R. 5124-73 for their production, hospital preparation and magistral preparation activities, are subject to the provisions of articles R. 5121-162, R. 5121-163 with the exception of 4°, R. 5121-164 with the exception of 3° and 5° and R. 5121-165. They report electronically to the European “Eudravigilance” database: 1° Any serious adverse reaction suspected to be…
The in-house pharmacies referred to in Article L. 5126-1 shall forward to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, immediately upon request, a report summarising the information relating to the adverse reactions which they have reported or which have been reported to them and all the information useful for assessing the risks and benefits associated with the use of the hospital…
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…
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is a Registered Trademark of
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75001, Paris France
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