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Showing 10671–10680 of 36632 articles for “Art. al. 5”
…t to compulsory prescription shall be provided with the unique identifier referred to in Article R. 5121-138-2, unless they are exempt from this requirement due to their presence on the list establish…
…by weight, volume or number of dosage units, as well as the name within the meaning of Article R. 5121-1 and the contents of the packaging of the proprietary medicinal product as it will be marketed…
…le for changing the packaging, in addition to the information provided for in e of 1° of Article R. 5121-149; 2° The full qualitative composition of excipients where this differs from that of the prop…
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 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…
…d procedure under the same conditions as those laid down for marketing authorisation in articles R. 5121-51 to R. 5121-51-7.
I. - The applicant or the holder of the registration shall forward to the Agency without delay, indicating the scope of the information, any new information which it has or becomes aware of after the…
…use authorisation for compassionate access if the conditions laid down in I, II and V of Article L. 5121-12-1 or if the provisions of this section are not complied with, or for any other public health…
The declaration provided for in the fourth paragraph of Article L. 5124-11 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by any means capable of providing a…
For pharmaceutical products with a parallel import authorisation, Customs officers check the import authorisation number on the packaging. If this number does not appear on the packaging at the time o…
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