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Showing 10811–10820 of 39241 articles for “Art. al. 6”
Within ninety days of the inspection of an establishment referred to in 1° or 2° of article R. 5142-1, a certificate of compliance with good practice is issued to the pharmacist or veterinarian respon…
For the application of article L. 5146-2, the inspectors mentioned in article L. 5146-4 are authorised to investigate and establish criminal offences, at the end of the adaptation period, by decision…
…e technical and administrative skills of the Agency's inspectors, mentioned in 1° of articles L. 5146-1 and L. 5146-2, and to validate their professional experience in the field of the good practices…
…France and who carries out one of the activities mentioned in Article R. 5211-52 or Article R. 5211-67 must make a declaration to the Agence nationale de sécurité du médicament et des produits de sant…
Implantable medical devices, active implantable medical devices and class III devices must be subject to clinical investigations, unless the use of existing clinical data can be duly justified.
The clinical evaluation and its results are included or duly referenced in the technical documentation for the device referred to in Article R. 5211-39. The clinical evaluation and its documentation a…
The decisions taken by the approved bodies under the procedures referred to in subsections 5, 6, 8 and 9 of section 6 of this chapter are valid for five years. They may be renewed for five-year period…
The manufacturer or his authorised representative shall, for a period of at least five years and, in the case of implantable devices, at least fifteen years after the last copy of the product has been…
The official veterinarians mentioned in 3° of article L. 5146-2, sworn in under the conditions defined in article R. 205-1 of the rural and maritime fishing code and authorised to investigate and reco…
Articles R. 523-12 to R. 523-21 of the Environmental Code apply to nanoparticulate substances used in the composition of health products intended for humans, cosmetic products mentioned in article L.…
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