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Showing 7431–7440 of 54001 articles for “Art. I-4°”
Before removing or partially or totally covering the safety features provided for in article R. 5121-138-2, the pharmaceutical establishment which manufactures medicinal products shall check that the…
By way of derogation from the provisions of the first sub-section, the provisions of this sub-section apply to the manufacture and importation of investigational medicinal products.
The pharmaceutical establishment manufacturing medicinal products mentioned in 1° of article L. 4211-1, generators, kits or precursors mentioned in 3° of this article has a documentation system compri…
For investigational medicinal products, the documents relating to each batch are kept by the pharmaceutical establishment which manufactures it, for at least five years after the end of the trial or t…
When the pharmacist in charge of a manufacturer, importer or operator of medicinal products other than investigational medicinal products, generators, kits or precursors referred to in 3° of article L…
The provisions of articles R. 5124-49 to R. 5124-55 are applicable to manufacturers and importers of dressing articles or articles presented as complying with the pharmacopoeia mentioned in 2° of arti…
Where manufacturers and importers of investigational medicinal products entrust certain quality control operations to a laboratory in accordance with Article R. 5124-47 (2°), the biomedical research s…
The manufacturer or importer of investigational medicinal products shall ensure that all manufacturing operations are carried out in accordance with the information provided by the sponsor in the appl…
The manufacturer and importer of medicinal products mentioned in 1° of article L. 4211-1, or of generators, kits or precursors mentioned in 3° of the said article, shall implement a pharmaceutical qua…
All the procedures required for each haemodialysis treatment session for these children are carried out by the care team, led by a nurse. At least one nurse with paediatric and dialysis experience for…
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