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Showing 13361–13370 of 39711 articles for “Art. al. 3”
…ractice relating to raw materials for pharmaceutical use is issued in accordance with Articles R. 5138-3 to R. 5138-6. When the inspection reveals serious breaches of the good practices mentioned in a…
Failure to make the information provided for in I and II of article L. 5232-5 available to the public under the conditions defined in article R. 5232-20 is punishable by a fifth-class fine. Failure to…
Vigilance includes: 1° For user healthcare professionals mentioned in Article L. 5232-4, the reporting to the Agence française de sécurité sanitaire des produits de santé of any incident consisting of…
…quested for authorisation or in the declaration or descriptive dossier provided for in Article L. 5138-1, in accordance with the conditions laid down in Articles R. 5138-1 and R. 5138-2, shall be puni…
…al organisation of the agency and its consultative committees; 2° Multiannual strategic guidelines; 3° The performance contract signed with the State; 4° The annual work programme; 5° The activity rep…
The Chairman sets the agenda on a proposal from the Chief Executive. Items which the Minister for Health, the Chairman of the Board of Directors or at least one third of its members request to be incl…
…three years, with the exception of the term of office of the members mentioned in 2° of article R. 5322-1. For the latter, the term of office of deputies ends with the legislature for which they were…
…té of the application for a certificate of good manufacturing practice provided for in Article R. 5131-2 of the Public Health Code gives rise to the prior payment of a fee. II - The amount of the fee…
The provisions of Section 2 of Chapter VII of Title II of Book I of this Part are applicable to the inspectors of the Agence nationale de sécurité du médicament et des produits de santé.
The information provided for in I and II of Article L. 5232-5 shall be made available in a dematerialised format, accessible free of charge and reusable in such a way as to allow aggregation. To this…
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