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Showing 1311–1320 of 4474 articles for “Art. n° 17-20.696”
The authorisation holder shall record any acquisition, transfer, import or export of micro-organisms and toxins or products containing them in a special register or by any appropriate computer system.…
The expert reports provided for in article R. 5141-16 consist of a critical evaluation of the various trials carried out, taking into account the state of scientific knowledge at the time of submissio…
The period of practical experience provided for in article R. 5142-16 is reduced : 1° To one year for professionals whose higher education was completed as part of a five-year programme ; 2° To six mo…
No medical device may be placed on the market or put into service in France unless it complies with the essential health and safety requirements referred to in section 5 of this chapter which apply to…
Reports are made :1° To the local materiovigilance correspondent when these reports are made by users or third parties who carry out their duties in one of the establishments or associations mentioned…
The manufacturer or his authorised representative, the importer or the distributor is required to keep, for each incoming and outgoing transaction, at least the following information: 1° The date of t…
For the application of this section, orders issued by the Minister for Health, on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, shall spe…
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…
The Scientific Advisory Board is responsible for : 1° To ensure the consistency of the Agency's scientific strategy, taking into account recent developments both in methodology and in knowledge of the…
When one or more cases of nosocomial infections have been detected and their nature corresponds to one or more of the reporting criteria defined in article R. 1413-79, the healthcare professional resp…
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