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Showing 3081–3090 of 64513 articles for “Art. L. 133-4 et R. 133-3”
…otified body's decision may be the subject of a complaint under the conditions laid down in Article R. 4313-35.
…e assessment of machinery technology. This team examines the technical file provided for in Article R. 4313-6. The assessment procedure includes an inspection visit to the manufacturer's premises.
…ody assesses, approves and monitors the application of the quality system of a machinery manufacturer. To this end, the notified body ensures that all measures have been taken concerning design, manuf…
…hich comply with the relevant harmonized standard satisfy the corresponding requirements of Article R. 4313-45.
To this end, all the elements, requirements and provisions adopted by the manufacturer are set out in systematic and rational documentation in the form of written measures, procedures and instructions…
The notified body shall examine the proposed modifications and decide whether it continues to meet the provisions of Article R. 4313-45. The decision is notified and may be the subject of a complaint…
The employer shall, in accordance with the conditions laid down in Article R. 4451-42, check the work equipment when it is put back into service after any maintenance operation in order to ensure that…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by a reasoned decision setting out the appeal procedures and deadlines, automatically vary, suspend…
The specific obligations which may be imposed pursuant to the third paragraph of Article L. 5121-9 and which must be mentioned in the risk management system are, in particular, the following: 1° The a…
The marketing authorisation is renewable on application by the holder to the National Agency for the Safety of Medicines and Health Products no later than nine months before its expiry date. The appli…
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