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Showing 6011–6020 of 55286 articles for “Art. s. 389 et 389-1”
…the registration dossier. This information concerns in particular the assessment of the quality, safety and homeopathic use of the medicinal product in the case of homeopathic medicinal products, the…
After registration, 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 artic…
…gilance 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 issued;2° F…
…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…
…s well as, where the medicinal product contains a maximum of three active substances, the non-proprietary name or names; the procedures for writing the name and strength in Braille, as well as the pro…
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…
…uct mentioned in Article R. 5121-150 ; 2° "Serious adverse reaction": an adverse reaction which is lethal or life-threatening, or which results in persistent or significant disability or incapacity, o…
…d the collection of information concerning them. In the case of medicinal products covered by a marketing authorisation or registration, this includes cases of use which comply or do not comply with t…
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