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Showing 4331–4340 of 34669 articles for “Art. R 418-9”
Health establishments authorised under this section which distribute advanced therapy medicinal products must keep at least the following information for each incoming and outgoing transaction: 1° The…
Changes other than those mentioned in articles R. 4211-58 and R. 4211-59 are declared in the annual activity report provided for in article R. 4211-62.
The authorised health care organisation sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Regional Health Agency an…
Health establishments authorised in application of this section may apply for a certificate of compliance with the good practices referred to in Article L. 5121-5. This certificate may be issued by th…
The provisions of articles R. 5124-3-1, with the exception of the last paragraph, R. 5124-4, R. 5124-48, R. 5124-57-1 to R. 5124-57-6 and R. 5124-60 are applicable to health establishments authorised…
Manufacturers of in vitro diagnostic medical devices may procure tissues, their derivatives and cells from the human body, whatever their level of processing, in a Member State of the European Union o…
I. - The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within three months of the date on which the application…
The Agence nationale de sécurité du médicament et des produits de santé has a period of four months to evaluate the information provided. At the end of these maximum four months, when, in application…
Pursuant to the fourth paragraph of the I of Article L. 1245-5, when the elements or products mentioned in Article R. 1245-1 do not benefit from the authorisation mentioned in Article L. 1243-2, estab…
I. - The application for authorisation provided for in the second paragraph of I of Article L. 1245-5 for products from Member States of the European Union or parties to the Agreement on the European…
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