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Showing 10551–10560 of 36632 articles for “Art. al. 5”
…": a noxious and unintended response to a medicinal product or to a product mentioned in Article R. 5121-150 ; 2° "Serious adverse reaction": an adverse reaction which is lethal or life-threatening, o…
…harmacist may present for direct access to the public under the conditions set out in article R. 4235-55. It is published on the Agency's website. At the request of the marketing authorisation holder…
The data referred to in II and III of Article R. 5121-201-5 and a copy of the administration record referred to in Article R. 5121-201-6 shall be kept by the establishments referred to in Article R. 5…
I.-This article applies to the post-authorisation studies referred to in article R. 5121-178 which are carried out by the holder of the authorisation referred to in article L. 5121-8 in order to compl…
The company or organisation exploiting a medicinal product or a product referred to in Article R. 5121-150 may not communicate information relating to pharmacovigilance to the general public about thi…
Without prejudice to the provisions of Article L. 5122-7, advertising of a medicinal product to the general public may not include any element which : 1° Makes medical consultation or surgical interve…
The authorisation may be subject to special conditions requiring the beneficiary of the authorisation to implement a plan for monitoring the efficacy and safety of the medicinal product, including the…
…of interruption or cessation of activity of a pharmaceutical establishment mentioned in article L. 5124-1 or article L. 5124-9-1 manufacturing advanced therapy medicinal products prepared on an ad ho…
…a blood-derived medicinal product directly to a patient, the information referred to in article R. 5121-187 is transcribed onto a special register marked and initialled by the mayor or police commiss…
The holder of the authorisation provided for in Article L. 4211-6 is required to report the following to the Director General of the Agence nationale de sécurité du médicament et des produits de santé…
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