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Showing 2501–2510 of 52215 articles for “Art. 428 al. 1”
…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…
…rogress. 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…
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…
When registration is suspended or withdrawn, the holder informs the stockholders without delay.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…
…labelling of the immediate packaging of a medicinal product or a product referred to in Article L. 5121-8, must include the following information, written in such a way as to be easily legible, clearl…
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…
…e 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 of t…
…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…
For the 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…
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