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Showing 3781–3790 of 63349 articles for “Art. 3-2° to 4°”
When assessing the quality system, the notified body shall consider that the elements of the quality system which comply with the relevant harmonized standard satisfy the corresponding requirements of…
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…
In order to obtain approval of its quality system, the manufacturer must submit an application for assessment to a body, which must include : 1° The name and address of the manufacturer ; 2° the place…
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 diplôme d'Etat de puéricultrice is awarded by the préfet de région to holders of a nursing or midwifery diploma validated for the practice of the profession in France, who have passed the competit…
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…
…icament et des produits de santé may require a company exploiting a blood-derived medicinal product to submit to its control samples of each batch of either the bulk product and the finished product,…
…726/2004 of the European Parliament and of the Council of 31 March 2004, urgent action is essential to protect human health or the environment, pending a final decision by the European Commission, the…
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