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Showing 1721–1730 of 5149 articles for “Art. 13 Nov 1992”
…accordance with Title VI of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as well as the par…
The certificates referred to in Article L. 5124-11 are issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These certificates are valid for three…
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…
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…
…subject to the specific provisions relating to them respectively, which are set out in articles R. 5132-27 and R. 5132-86.
The holder of a parallel import authorisation shall immediately inform the holder of the marketing authorisation in the State of origin and the holder of the marketing authorisation for the medicinal…
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…
When, in application of the second paragraph of Article L. 5124-11, the Director General of the Agence nationale de sécurité du médicament et des produits de santé intends to prohibit the export of a…
I.- In addition to the company's distinctive sign, the outer packaging may include signs or pictograms explaining some of the above information, as well as other information compatible with the summar…
Any change in the holder of an authorisation to open a pharmaceutical establishment is subject to prior authorisation. However, the Director General of the Agence nationale de sécurité du médicament e…
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