Article R5121-115
…e European Economic Area, in which it has obtained a marketing authorisation; 2° Whose quantitative and qualitative composition in terms of active substances and excipients, pharmaceutical form and th…
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Showing 2971–2980 of 58235 articles for “Art. n° 10-10095 and n° 10-30215”
…e European Economic Area, in which it has obtained a marketing authorisation; 2° Whose quantitative and qualitative composition in terms of active substances and excipients, pharmaceutical form and th…
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…
…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…
I.- Articles R. 5121-133 to R. 5121-135 do not apply to gene therapy and xenogenic cell therapy preparations. II-Any gene therapy or xenogenic cell therapy preparation that does not have the authorisa…
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…
…ct, he shall first notify the pharmaceutical establishment carrying out the export of his intention and the reasons for it. The latter has one month to submit its observations. In urgent cases, the Di…
It is prohibited for a professional to solicit or collect collection fees from a consumer under conditions contrary to the
…he alleged debtors are obliged, if so requested, to affirm on oath that they are no longer indebted and their widows, heirs or successors, that they believe in good faith that they no longer owe anyth…
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