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Showing 1881–1890 of 6040 articles for “Art. 11 déc. 1996”
The standards and methods applicable to the testing of medicinal products are set, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, b…
I.-Articles R. 4233-33 to R. 4233-38 are applicable in New Caledonia and French Polynesia in the version set out in Decree no. 2022-381 of 16 March 2022, subject to the adaptations set out in II. II.-…
Private individuals may only import a medicinal product in a quantity compatible with personal therapeutic use for a period of treatment not exceeding three months under normal conditions of use, or f…
…e with Article 51 of the aforementioned Directive; 3° Subject to the provisions of Articles R. 5121-117 to R. 5121-119, the contents of the packaging in terms of weight, volume or number of dosage uni…
…Agence 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, th…
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…
The package leaflet of the proprietary medicinal product benefiting from a parallel import authorisation is identical to that of the proprietary medicinal product which has obtained marketing authoris…
…erapy preparations, the name and address of the establishment or body authorised under Article L. 4211-8 or Article L. 4211-9; 2° The country of origin and, if different, the country of origin of the…
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…
…ys 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 previous paragraph is extended by fifteen days…
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