The drug dependence and addictovigilance assessment and information centres carry out their vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
An order of the Minister for Health, issued on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé and after consultation with the Commission nationale de l’informatique et des libertés, defines the operating procedures for the computer system, common to all drug dependence and addictovigilance assessment and information centres, designed to collect, record, evaluate and use data relating to cases…
The leaflet accompanying each registered reagent includes the following information in French for the user: 1° The name of the reagent, together with an indication of its diagnostic and therapeutic purpose; 2° The name and address of the manufacturer, distributor and, where applicable, importer; 3° The nature of the main component(s) and, where applicable, the composition of the calibration solutions required for use of the reagent; 4° Relevant information on…
The immediate packaging and the outer packaging, within the meaning of Article R. 5121-1, include the following information written in French for the user: 1° The name of the reagent ; 2° The name and address of the distributor ; 3° The indication “in vitro use”; 4° If necessary, the indication “danger”; 5° Storage conditions; 6° The expiry date; 7° Manufacturing batch number.
The content of the information provided for in articles R. 5133-1 and R. 5133-2 for reagents requiring special precautions for use may be specified, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health.
Manufacturers, importers and distributors of reagents, as well as users, and in particular medical biology analysis laboratories, shall transmit to the Agence nationale de sécurité du médicament et des produits de santé any information on unexpected or undesirable effects, or on shortcomings or errors, likely to be due to these reagents and of which they are aware.
Where it appears that a reagent presents risks to public health, including as a result of non-compliance with the rules laid down in this chapter, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall notify the manufacturer, importer or distributor, informing it of his intentions and inviting it to submit its observations within a period which may not exceed one month. In…
The dispensing to minors of medicinal products indicated for emergency contraception and not subject to compulsory medical prescription by virtue of the second paragraph of article L. 5134-1 is carried out in conditions of confidentiality allowing a conversation to take place without the risk of third parties. In addition to complying with the provisions of article R. 4235-48, dispensing by the pharmacist is preceded by an interview to ensure that…
The minority to which the free dispensing provided for in article L. 5134-1 is subject is justified by an oral declaration made to the pharmacist by the person concerned.
When a minor has been dispensed the medicinal products indicated in the emergency contraception, the pharmacist sends the health insurance fund to which he belongs an invoice drawn up on a care sheet which does not include the identification of the insured person and the beneficiary and uses a paper medium. This invoice may be sent electronically.
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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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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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