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Showing 1541–1550 of 59948 articles for “Art. R. 612-1”
By way of derogation from the provisions of article R. 5121-99, the registration lapses if it appears that it is not followed by the marketing of the medicinal product on the national territory within…
The information provided for in Articles R. 5121-138 and R. 5121-139 is written in French. They may also be written in other languages, provided that the same information appears in all the languages…
…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When registration is suspended or withdrawn, the holder informs the stockholders without delay.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…
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