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Showing 5181–5190 of 66666 articles for “Art. 382-1 and 387-1”
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…
…information: 1° The name of the medicinal product or product, the strength, the pharmaceutical form and, where appropriate, the name of the recipient ("infants", "children" or "adults") and, where the…
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…
…h 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 articl…
…he purposes of this chapter, the following definitions shall apply 1° "Adverse reaction": a noxious and unintended response to a medicinal product or to a product mentioned in Article R. 5121-150 ; 2°…
…l product or a product mentioned in article R. 5121-150, including cases of overdose, misuse, abuse and medicinal errors as defined in article R. 5121-152, as well as the monitoring of adverse reactio…
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