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Showing 1891–1900 of 6499 articles for “Art. n° 11-11.115”
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…
Except where there are public health reasons for not doing so, parallel import authorisation is granted if the following conditions are met: 1° The proprietary medicinal product is obtained from an au…
The application must be accompanied by : 1° For medicinal products imported for research involving the human person, an acknowledgement of receipt of the application sent to the Agence nationale de sé…
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…
The application 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 re…
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…
If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent, the authorisation will be refused on expiry of a period of forty-five days from the d…
The import authorisation or, for private individuals, a copy of the authorisation to import by a means other than personal transport, referred to in article R. 5121-109, or a copy of the compassionate…
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