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Showing 2491–2500 of 52208 articles for “Art. 477-1”
I. - The applicant or the holder of the registration shall forward to the Agency without delay, indicating the scope of the information, any new information which it has or becomes aware of after the…
Ampoules or other small 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 medicina…
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…
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When registration is suspended or withdrawn, the holder informs the stockholders without delay.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…
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…
I.- In addition to the company's distinctive sign, the outer packaging may include signs or pictograms explaining some of the above information, as well as other information compatible with the summar…
The information contained in advertising for a medicinal product must comply with the information given in the summary of product characteristics referred to in article R. 5121-21 and with the therape…
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