Article R5211-63
Where an authorized body finds that the requirements of this Title applicable to this device have not been met or are no longer being met by the manufacturer, or where a certificate should not have be…
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Showing 10831–10840 of 39241 articles for “Art. al. 6”
Where an authorized body finds that the requirements of this Title applicable to this device have not been met or are no longer being met by the manufacturer, or where a certificate should not have be…
The approved body may require the manufacturer to provide any information and to carry out any test or assessment necessary for it to carry out the verifications for which it is responsible.
The Agency's inspectors will carry out inspections as decided by the Agency's Director General, who will issue a letter of assignment to the inspector in charge of the investigation. This letter speci…
The systems and kits are accompanied by the information mentioned in Article R. 5211-22, including, where applicable, the information supplied by the manufacturers of the devices that have been assemb…
If a system or kit does not meet the conditions set out in Article R. 5211-67, and in particular if it contains devices not bearing the CE marking or if the compatibility of the assembled devices is n…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn…
The CE mark is affixed under the responsibility of the manufacturer or his authorised representative. Its form and dimensions are laid down by order of the Minister for Health. The CE marking must be…
A breeding health programme, within the meaning of article L. 5143-6, is the definition of interventions that must be carried out systematically for prophylactic purposes on an entire herd, batch or b…
Medicated premixes and medicated feeds are stored in locked premises or in hermetically sealed containers separated by category and specially designed for the conservation of these products.
The necessary measures are taken to prevent contamination of other food categories by medicated feed and contamination of medicated feed during manufacture, import, distribution or transport.
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