Article R5131-12
The vigilance exercised over cosmetic products by the Agence nationale de sécurité du médicament et des produits de santé includes : 1° Receiving and recording serious adverse reaction reports sent by…
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Showing 3091–3100 of 8110 articles for “Art. CA Montpellier 21-12-2011”
The vigilance exercised over cosmetic products by the Agence nationale de sécurité du médicament et des produits de santé includes : 1° Receiving and recording serious adverse reaction reports sent by…
…r weeks or one month of thirty days, depending on the packaging, may not be dispensed on a single occasion. However, medicinal products packaged for a treatment period of more than one month may be di…
One of the samples is left with the owner or holder of the product. If the interested party refuses to keep the said sample on deposit, this refusal will be mentioned in the report or the minutes. Und…
…essential for the proper use of the product or object;c) An express and legible invitation to read carefully the instructions in the package leaflet or on the outer packaging, as the case may be.In t…
…d for in 1° of Article R. 5139-3 up to date and sends it to the Agence nationale de sécurité du médicament et des produits de santé by 15 February each year at the latest. Any change to this list duri…
…belonging to one of the species whose flesh or products are intended for human consumption plans to carry out medicinal product trials other than those mentioned in article R. 234-4, he must make a de…
The registers or records mentioned in articles R. 5141-118 to R. 5141-120 are kept for five years and must be produced whenever required by the competent authorities. The recording systems comply with…
…the authorisation holder has been given the opportunity to present his observations. Except in the case of recourse to a parallel import authorisation procedure or in the case of import of a veterina…
Veterinarians alone are authorised to administer, in the case provided for in a of 3° of article L. 5143-4, to animals whose flesh or products are not intended for human consumption, medicinal product…
…ndrogenic or gestagenic action for farm animals shall record the following information in chronological order in a register or by any appropriate recording system: 1° Number of the prescription prescr…
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