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Showing 1691–1700 of 58742 articles for “Art. s. 1844-11 and 1844-13”
…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…
…to in 12° or 13° of article L. 5121-1 must be presented at the time of inspection by customs officers.For imported medicinal products required for biomedical research, a document drawn up by the Agenc…
…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…
…ation necessary for the examination of the application. The deadlines set out in Articles R. 5124-9 and R. 5124-10 are then suspended until this information is received.
The director of the training organisation is responsible for organising the ballot. He/she shall ensure that it runs smoothly.
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