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Showing 5331–5340 of 66755 articles for “Art. 492 al. 1 and Art. 493 al. 1”
…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 risk…
…primary packaging on which it is impossible to include all the information specified in Article R. 5121-138 may bear only the following information: 1° The name of the medicinal product or product, th…
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…
By way of derogation from the provisions of Article R. 5121-138, when the medicinal products or products are contained in an outer packaging that complies with the requirements of the said Article, th…
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 Agency will take all appropriate measures. Independently of suspension or withdrawal decisions and for the reasons that justify them, the Director General of the Agency may prohibit, as a precaut…
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…
…ompatible with the summary of product characteristics. This information must be useful for patients and must not be promotional in nature. II -When the medicinal product or product has effects on the…
…ply with the information given in the summary of product characteristics referred to in article R. 5121-21 and with the therapeutic strategies recommended by the Haute Autorité de santé referred to in…
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