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Showing 2071–2080 of 38502 articles for “Art. L 227-12”
One of the samples is left with the owner or holder of the product. If the interested party refuses to keep the said sample on deposit, this refusal will be mentioned in the report or the minutes. Und…
Advertising to the public for a product or object defined in article R. 5134-11 :1° Is designed in such a way that the advertising nature of the message is obvious ;2° Contains at least :a) The name o…
The authorisation holder keeps the list provided for in 1° of Article R. 5139-3 up to date and sends it to the Agence nationale de sécurité du médicament et des produits de santé by 15 February each y…
The registers or records mentioned in articles R. 5141-118 to R. 5141-120 are kept for five years and must be produced whenever required by the competent authorities. The recording systems comply with…
A veterinary surgeon who prescribes medicinal products containing substances having an oestrogenic, androgenic or gestagenic action for farm animals shall record the following information in chronolog…
If, within a period of two years following notification of the authorisations provided for in articles R. 5142-8 to R. 5142-10, the establishment is not operating, these authorisations lapse. However,…
…or party to the Agreement on the European Economic Area when they are imported corresponds to a model laid down by decision of the Director General of the Agence nationale de sécurité sanitaire de l'a…
Any medical device placed on the market or put into service in France must bear the CE mark certifying that it meets the conditions set out in article R. 5211-17. However, CE marking is not required f…
User healthcare professionals not practising in one of the establishments mentioned in 4° of Article R. 5222-3 or in a blood transfusion establishment who are aware of incidents or risks of incidents…
Any health establishment or health cooperation group which uses or supplies medical devices or makes such devices available to its members, as well as any association distributing medical devices at h…
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