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Showing 1581–1590 of 58613 articles for “Art. 11° and 12°”
…product, as well as the overall quantity of the medicinal product in question that may be imported and the period during which the operations may be carried out. Importation may be prohibited by the…
…horised company within the meaning of Article 77 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human…
…nationale de sécurité du médicament et des produits de santé as provided for in articles L. 1123-8 and R. 1123-30 ; however, where the implementation of the research is of an urgent nature, this docu…
The proprietary medicinal product for which parallel import authorisation is sought may differ from the proprietary medicinal product which has already obtained marketing authorisation in France, as r…
…s obtained marketing authorisation in France, except that it includes : 1° The addition of the name and address of the establishment responsible for changing the packaging, in addition to the informat…
…plication for an import authorisation must be sent by any means capable of providing a date certain and must indicate : 1° The name or business name and address of the natural or legal person responsi…
The labelling and outer packaging of the proprietary medicinal product benefiting from a parallel import authorisation are identical to those of the proprietary medicinal product which has obtained ma…
…fused on expiry of a period of forty-five days from the date of receipt of the complete application and dossier referred to in Articles R. 5121-111 and R. 5121-112. The time limit mentioned in the pre…
…5121-12-1 granted for an imported medicinal product or a copy of the authorisation referred to in 12° or 13° of article L. 5121-1 must be presented at the time of inspection by customs officers.For…
…e European Economic Area, in which it has obtained a marketing authorisation; 2° Whose quantitative and qualitative composition in terms of active substances and excipients, pharmaceutical form and th…
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