Article R5121-162
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 shall implement a pharmacovigilance system in order to fulfil its pharmacovigilance obligations…
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Showing 10571–10580 of 36632 articles for “Art. al. 5”
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 shall implement a pharmacovigilance system in order to fulfil its pharmacovigilance obligations…
…erse reaction suspected of being due to a medicinal product or to a product mentioned in article R. 5121-150 of which he is aware to the regional pharmacovigilance centre.Other healthcare professional…
…by any company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150, that, due to their concerns regarding the safety of a medicinal product, the marketing of…
The verbal presentation of a medicinal product is made by a person mentioned in Article L. 5122-11 and is accompanied by the hand-delivery by that person to the healthcare professional of: 1° The summ…
The information contained in the advertisement must be accurate, up to date, verifiable and sufficiently complete to enable the recipient to form a personal opinion of the therapeutic value of the med…
…ared on an ad hoc basis mean the advanced therapy medicinal products mentioned in 17° of Article L. 5121-1.For the purposes of II of Article L. 4211-9-1, only advanced therapy medicinal products prepa…
…e. This supply is managed in accordance with the provisions of the order provided for in article R. 5132-42. When a medicinal product is taken from the supply provided for in the previous paragraph, t…
For the medicinal products mentioned in 1° of II of article L. 5121-12 and in II of article L. 5121-12-1, the obligations set out in article R. 5121-161 and articles R. 5121-166 to R. 5121-170 are car…
The regional pharmacovigilance centres carry out vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
…e drug dependence and addictovigilance assessment and information centres referred to in article R. 5132-112 and the poison control centres referred to in article L. 6141-4 to provide him with any inf…
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