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Showing 3011–3020 of 53011 articles for “Art. CE 1-10-2013 n° 361440”
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail will notify the applicant of his decision within one hundred and twenty days from…
…es and the address of the preparation site. It specifies the pathogens by target species, the pharmaceutical forms and the authorised adjuvants.
The authorisation holder ensures that data from professional practices is collected and analysed with a view to improving practices and managing risks. The medical team mentioned in 1° of article D. 6…
The parallel import authorisation is granted for a period of five years. It specifies the differences mentioned in articles R. 5121-117 to R. 5121-119 with the speciality that has obtained marketing a…
…inal product in a quantity compatible with personal therapeutic use for a period of treatment not exceeding three months under normal conditions of use, or for the period of treatment stipulated in th…
…s before the expiry date of the parallel import authorisation. It must be accompanied by a document certifying that there has been no change in the information provided by the interested party, either…
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…
Except where there are public health reasons for not doing so, parallel import authorisation is granted if the following conditions are met: 1° The proprietary medicinal product is obtained from an au…
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…
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