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Showing 4491–4500 of 34871 articles for “Art. R. 145-9”
I.-The following changes to the authorisation are subject to declaration: 1° Change in the corporate name of the establishment or the administrative address of the authorisation holder; 2° Appointment…
In the event of non-compliance with the legislative and regulatory provisions or the conditions of the authorisation, the suspension, which may not exceed one year, and the withdrawal of the authorisa…
I.-Substantial changes to the activities authorised under this section relating to ... are subject to authorisation by the Director General of the Agence nationale de sécurité du médicament et des pro…
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…
…de santé for all or part of the activities inspected to the responsible person mentioned in article R. 4211-55, within ninety days of an inspection. It may not be used to guarantee the safety or quali…
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…
…ature or origin of the products as well as the substantial modifications mentioned in 4° of Article R. 1243-7 is subject to authorisation issued by the Director General of the Agence nationale de sécu…
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