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Showing 2511–2520 of 52212 articles for “Art. 1844-1”
When a medicinal product is the subject of a marketing authorisation granted by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 200…
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…
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When registration is suspended or withdrawn, the holder informs the stockholders without delay.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…
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