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Showing 3921–3930 of 8197 articles for “Art. 9 janv. 1991”
I.-When one of the results of individual dosimetric monitoring exceeds one of the limit values laid down in Article R. 4451-6, the dosimetry organisation referred to in I of Article R. 4451-65 shall i…
Any worker whose health status exceeds one of the limit values set out in articles R. 4451-6, R. 4451-7 and R. 4451-8 will benefit from the health monitoring applicable to workers classified in catego…
I.-When a worker's exposure exceeds one of the limit values laid down in articles R. 4451-6, R. 4451-7 and R. 4451-8, the employer shall immediately take steps to: 1° Stop the exposure; 2° Determine a…
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…
…du médicament et des produits de santé: 1° A new activity, among those mentioned in article L. 4211-9-2 ; 2° The manufacture or import of a new category of investigational advanced therapy medicinal p…
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…
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