The Director General of the Agence nationale de sécurité du médicament et des produits de santé provides all relevant information to the European Medicines Agency, as well as to the International Narcotics Control Board of the United Nations and to the World Health Organisation in application of the international conventions on narcotic drugs and psychotropic substances.
Any doctor, dental surgeon or midwife who becomes aware of a serious case of pharmacodependence, abuse or misuse of a substance, plant, medicinal product or other product mentioned in article R. 5132-98 must immediately report it to the centre for assessment and information on pharmacodependence in whose territory the case was discovered. Similarly, any pharmacist who becomes aware of a serious case of pharmacodependence, abuse or serious misuse or serious…
Any company or organisation exploiting a medicinal product or product mentioned in article R. 5132-98 must immediately report any serious case of pharmacodependence, abuse or misuse of this medicinal product or product of which it is aware to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
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…
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is a Registered Trademark of
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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