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Showing 11901–11910 of 38939 articles for “Art. al. 4”
…medicinal product or product is compulsory, unless the information referred to in article R. 5121-149 appears directly on the outer packaging or the immediate packaging. It must be written in French,…
Without prejudice to the provisions of Article R. 5132-15, the labelling of the immediate packaging and, if available, the outer packaging of the preparations mentioned in 1° to 3° of Article L. 5121-…
In addition to the information provided for in articles R. 5121-138 and R. 5121-149, the labelling and package leaflet of traditional herbal medicinal products indicate that: 1° The product is a tradi…
…nal product and, if the proprietor does not manufacture the medicinal product, of the manufacturer; 4° The route of administration and, if necessary, the method of administration; 5° The expiry date i…
Where, following the establishment of a new Community herbal monograph, the revision of an existing monograph or the revision of the list drawn up by the European Commission in application of Article…
The marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any proposed amendment to the labelling or package le…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse the marketing authorisation on the grounds mentioned in Article L. 5121-9. The application…
…of the marketing authorisation;3° The designation of the manufacturing, testing and packaging sites;4° An undertaking by the applicant to comply with all the conditions to which the marketing authoris…
1° In the interests of patients or for any other public health reason and, where appropriate, at the request of the Minister for Health, the Director General of the Agence nationale de sécurité du méd…
When a change in the classification mentioned in 1° of Article R. 5121-36 is authorised, on the basis of preclinical and clinical studies considered to be significant during the scientific evaluation…
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