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Showing 3381–3390 of 64157 articles for “Art. L. 223-17 and L. 221-14”
…by a foreign national residing outside national territory or a foreign national residing in France and holding a residence permit as provided for in article R. 5221-3.
…s of chemical, pharmaceutical, biological, pharmacological or toxicological tests with:1° The title and objective of the test requested ;2° Identification of the medicinal product to be tested:a) Its…
…he immediate packaging. It must be written in French, in terms that are easy for the user to understand and sufficiently legible, taking into account the results of consultation with groups of patient…
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…
…information: 1° The name of the medicinal product or product, the strength, the pharmaceutical form and, where appropriate, a reference to the recipient ("infants", "children" or "adults") and, where…
…information: 1° The name of the medicinal product or product, the strength, the pharmaceutical form and, where appropriate, the name of the recipient ("infants", "children" or "adults") and, where the…
The marketing authorisation holder must comply with the good package leaflet practices established by decision of the Director General of the Agence nationale de sécurité du médicament et des produits…
…ng of the protective shielding provides all the explanations relating to the codes used on the vial and indicates, where applicable, the total or unit quantity of radioactivity for a given time and da…
…kage leaflet is drawn up in accordance with the summary of product characteristics. It includes a standard text, expressly inviting patients to report any suspected adverse reaction to their doctor, p…
When the application is submitted, the applicant assigns an internal reference number to each of the advertising media, in accordance with the rules defined by a decision of the Director General of th…
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