Article R4313-55
The manufacturer must keep at the disposal of the national authorities, for a period of ten years from the last date of manufacture, the elements to be transmitted with any application for assessment…
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Showing 4401–4410 of 52239 articles for “Art. 35 I 5° bis”
The manufacturer must keep at the disposal of the national authorities, for a period of ten years from the last date of manufacture, the elements to be transmitted with any application for assessment…
The notified body checks, by means of surveillance, that the manufacturer duly fulfils the obligations arising out of the approved quality assurance system.
The manufacturer 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 document…
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 employer shall make the results of the checks provided for in this section available to the health professionals referred to in the first paragraph of Article L. 4624-1 and to the Social and Econo…
The training of the workers mentioned in II of article R. 4451-58 is paid for by the employer and renewed at least every three years.
Candidates who hold certain French or foreign diplomas or qualifications may be exempted from one or more of the professional tests or units that make up the pharmacy technician vocational diploma (br…
By way of derogation from the provisions of sub-sections 1 and 2 of section 2 of Chapter IV of Title II of Book VI of Part Four of this Code, the information and prevention visit or the pre-recruitmen…
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