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Showing 1561–1570 of 59934 articles for “Art. R. 232-1”
…or after the registration has been granted, which could lead to a change in the registration dossier. This information concerns in particular the assessment of the quality, safety and homeopathic use…
…all 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…
…al progress. Any resulting changes must first be registered under the conditions set out in article R. 5121-100-1.
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…
…cess authorisation, subject to the specific rules laid down for these medicinal products in article R. 5121-172 ;3° For the homeopathic medicinal products mentioned in article L. 5121-13, after the re…
When registration is suspended or withdrawn, the holder informs the stockholders without delay. They must take all necessary steps to stop the distribution of the medicinal product. If these steps are…
…by the national number identifying the presentation of the medicinal product referred to in article R. 5121-4; 14° For medicinal products not subject to prescription, the therapeutic indication; 15° (…
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…
…g the pictogram provided for in II or III which he uses, without applying the provisions of Article R. 5121-41. V.-In the event of non-compliance with the provisions of II, III and IV, the suspension…
…comply 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 t…
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