Article R5131-1
The declaration provided for in article L. 5131-2 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by a person authorised to bind the company to which the estab…
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Showing 3691–3700 of 68192 articles for “Art. s. R 232-22 and R 123-154-1”
The declaration provided for in article L. 5131-2 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by a person authorised to bind the company to which the estab…
The following incidents may be reported: 1° A noxious and unintended reaction occurring during the use of a medical device in accordance with its intended purpose; 2° A noxious and unintended reaction…
Reports are made :1° To the local materiovigilance correspondent when these reports are made by users or third parties who carry out their duties in one of the establishments or associations mentioned…
The reports, whether mandatory or optional, provided for in articles R. 5212-14 and R. 5212-15 are made by manufacturers or their representatives, users or third parties who observe or are aware of in…
When the facts mentioned in Article L. 5212-2 are brought to the attention of the Director General of the Agence nationale de sécurité du médicament et des produits de santé by a user or a third party…
Incidents or risks of incidents as defined in Article L. 5212-2 must be reported immediately.
I.-The agreement establishing the regional hospital grouping consists of two parts: 1° The section relating to the shared medical project provided for in I of Article L. 6132-1 ; 2° The section relati…
The authorisation referred to in 2° of I of article 15-4 may only be issued to the agent benefiting from the authorisation referred to in the second paragraph of I of the same article. It shall be iss…
Irrespective of each member's contribution to the operating costs of the grouping, the medical procedures and consultations referred to in the second and third paragraphs of article L. 6133-6, provide…
I.-The health cooperation grouping jointly operating the authorisations held by one or more of its members on a single geographical site may be authorised by the Director General of the Regional Healt…
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