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Showing 2801–2810 of 52403 articles for “Art. s. 414-1”
I. - The applicant or the holder of the registration shall forward to the Agency without delay, indicating the scope of the information, any new information which it has or becomes aware of after the…
…ation, manufacturing methods and control techniques take account of scientific and technical progress. Any resulting changes must first be registered under the conditions set out in article R. 5121-10…
Pharmacovigilance is carried out :1° For medicinal products and for products which must be covered by the marketing authorisation provided for in article L. 5121-8, after this authorisation has been i…
…the interests of public health, the Director General of the Agency will take all appropriate measures. Independently of suspension or withdrawal decisions and for the reasons that justify them, the Di…
Without prejudice to the information required by other legislative and regulatory provisions, the labelling of the outer packaging or, where there is no outer packaging, the labelling of the immediate…
Registration of homeopathic medicinal products and traditional herbal medicinal products, as well as suspension and withdrawal of registration, are made available to the public by the Director General…
…bove information, as well as other information compatible with the summary of product characteristics. This information must be useful for patients and must not be promotional in nature. II -When the…
The information contained in advertising for a medicinal product must comply with the information given in the summary of product characteristics referred to in article R. 5121-21 and with the therape…
…minimising these risks, including the evaluation of the effectiveness of said activities and measures. This set of activities and measures shall be proportionate to the proven risks and potential risk…
…nformation with a view to preventing or reducing risks and, if necessary, taking appropriate measures. This information is analysed taking into account available data relating to the sale, supply and…
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