Article R5141-123-18
…tion holder in the country of origin of any serious adverse reaction, within the meaning of Article R. 5141-92, concerning the imported proprietary medicinal product, as soon as he is aware of it.
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Showing 71–80 of 62190 articles for “Art. R. 123-54 and R. 123-103 · C. civ. Art. 1857”
…tion holder in the country of origin of any serious adverse reaction, within the meaning of Article R. 5141-92, concerning the imported proprietary medicinal product, as soon as he is aware of it.
The administrative authority referred to in articles L. 1237-19-3 to L. 1237-19-5, L. 1237-19-7 and L. 1237-19-8 is the regional director of companies, competition, consumption, labour and employment…
…a sample of the proprietary medicinal product which has obtained marketing authorisation in France and a sample of the proprietary medicinal product marketed in the country of origin, which is intend…
…ained marketing authorisation in France, provided that these differences have no therapeutic impact and do not entail any risk to public health.II. - The labelling of the proprietary veterinary medici…
The copy of the import authorisation or temporary use authorisation referred to in article L. 5141-10 is presented during the inspection by the customs officers. For imported veterinary medicinal prod…
…by the same company or by an associated company or working under licence with the same quantitative and qualitative composition in active ingredients and excipients and the same pharmaceutical form as…
…d by an authorisation for a series of import operations envisaged over a maximum period of one year and for a given overall quantity. The same applies to veterinary medicinal products intended for sto…
…of the parallel import authorisation in the summary of product characteristics, the package leaflet and the labelling of the proprietary veterinary medicinal product as marketed in France.
After it has been issued, the parallel import authorisation is suspended or withdrawn by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du…
I.- In the event of repackaging, the holder of a parallel import authorisation for a proprietary veterinary medicinal product shall notify the holder of the marketing authorisation for the proprietary…
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