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Showing 4171–4180 of 69543 articles for “Art. 515-5-1 and 515-5-2”
…cle L. 5142-3 applicable to these activities, sets out the respective obligations of the depository and the operator on whose behalf it is acting. They may only distribute batches of veterinary medici…
A veterinary pharmaceutical establishment mentioned in article R. 5142-1 engaged in the wholesale, free transfer or wholesale distribution of veterinary medicinal products must have an emergency plan…
The manufacturer undertakes to fulfil all the conditions necessary for the approved quality system to remain effective.
…lication for assessment of the quality system listed in article R. 4313-44 as well as the decisions and reports provided for in articles R. 4313-48, R. 4313-49, R. 4313-53 and R. 4313-54.
The notified body checks, by means of surveillance, that the manufacturer duly fulfils the obligations arising out of the approved quality assurance system.
…er must allow the notified body access to the locations of design, manufacture, inspection, testing and storage and must provide all necessary information, in particular: 1° the documentation on the q…
If the body considers that the conditions necessary for approval of the quality system are no longer fulfilled, it will withdraw this approval. This withdrawal prohibits the placing on the market of t…
The notified body carries out periodic audits to ensure that the manufacturer maintains and applies the approved quality system. It provides the manufacturer with an audit report. The frequency of the…
The notified body makes unannounced visits to the manufacturer, the need for and frequency of which are determined on the basis of the control system managed by the body. The criteria for choosing the…
The provisions of articles R. 112-40 and R. 112-45 do not apply in Guadeloupe, French Guiana, Martinique, Reunion Island, Mayotte, Saint-Barthélemy, Saint-Martin, Saint-Pierre et Miquelon, Wallis and…
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