Article R5121-121
The application for a parallel import authorisation is accompanied by a dossier comprising : 1° A sample of the proprietary medicinal product which has obtained marketing authorisation in France and a…
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Showing 5831–5840 of 30455 articles for “Art. Cass. 1ère civ. avis 20-10-2022 n° 22-70.011 B”
The application for a parallel import authorisation is accompanied by a dossier comprising : 1° A sample of the proprietary medicinal product which has obtained marketing authorisation in France and a…
…part ; 2° Medicinal products classified as psychotropic. However, these medicinal products remain subject to the specific provisions relating to them respectively, which are set out in articles R. 513…
…State of origin and the holder of the marketing authorisation for the medicinal product which has obtained the marketing authorisation in France of any serious adverse reaction, within the meaning of…
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
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…
…sier referred to in Articles R. 5121-120 and R. 5121-121, authorisation of the parallel import will be refused. This time limit is extended by fifteen days if the Director General of the Agency reques…
…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 date of receipt of the complete applica…
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…
…a parallel import with a view to placing it on the market in France: 1° Which comes from another Member State of the European Community or party to the Agreement on the European Economic Area, in whic…
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