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Showing 13421–13430 of 39711 articles for “Art. al. 3”
…of veterinary medicinal products by the groups provided for in the first paragraph of article L. 5143-6 are carried out under the supervision of a pharmacist who actually participates in the technical…
The evaluation of the clinical data referred to in Article L. 5211-3-2, hereinafter referred to as the "clinical evaluation", must, taking into account any relevant harmonised standards, follow a proc…
…to medical devices to be the subject of clinical investigations ; 2° EC declaration of conformity ; 3° EC type-examination ; 4° EC verification ; 5° Declaration relating to custom-made medical devices…
…th the good manufacturing practice for veterinary medicinal products referred to in article L. 5142-3 . This certificate relates to the conditions under which the various pharmaceutical operations wer…
For the purposes of article L. 5143-3, a user approved to carry out the extemporaneous preparation of medicated feedingstuffs means the professional keeper of animals belonging to species whose flesh…
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.
…ded or duly referenced in the technical documentation for the device referred to in Article R. 5211-39. The clinical evaluation and its documentation are updated using data obtained during post-market…
…tory, the Director General of the Agency may implement the measures provided for in Article L. 5145-3.These measures are made public on the website of the Agence nationale de sécurité sanitaire de l'a…
…products, including the extemporaneous preparation of medicated feed provided for in article L. 5143-3, is carried out in accordance with good practice, the principles of which are defined, on a prop…
…conformity, full quality assurance system ; 2° EC type examination, combined with EC verification; 3° EC type-examination, combined with EC declaration of conformity, production quality assurance.
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