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Showing 2941–2950 of 66828 articles for “Art. al. 1 and 1844-10”
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…
…remains silent for a period of forty-five days from the date of receipt of the complete application and dossier referred to in Articles R. 5121-120 and R. 5121-121, authorisation of the parallel impor…
…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…
…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 access authorisation under II of article L. 5121-12-1 grante…
…medicinal product constitutes 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…
The holder of a parallel import authorisation notifies the holder of the marketing authorisation for the proprietary medicinal product in the Member State of origin of the marketing in France of the p…
…duct benefiting from the parallel import authorisation complies with the provisions of Articles R. 5121-118, R. 5121-119 and R. 5121-128.
…icinal product being imported, stating the parallel import authorisation number, the name, strength and pharmaceutical form of the imported medicinal product and the country of origin.
…nce relating to:-the summary of product characteristics, with the exception of the stability period and special storage precautions, which are those provided for in the marketing authorisation obtaine…
The operation, as defined in the second paragraph of 3° of Article R. 5124-2, of a proprietary medicinal product benefiting from a parallel import authorisation is carried out by the holder of this au…
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