Article R5141-49
Post-authorisation studies may be carried out, on behalf of this licence holder and under its responsibility, by another company or organisation. Any study must be the subject of a protocol validated…
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Showing 561–570 of 60191 articles for “Art. avis 2013-027 of 4 October 2013”
Post-authorisation studies may be carried out, on behalf of this licence holder and under its responsibility, by another company or organisation. Any study must be the subject of a protocol validated…
…es on veterinary medicinal products that already have a marketing authorisation" within the meaning of 6° of article L. 5141-16, hereinafter referred to as "post-authorisation studies", means studies…
…in their departmental correspondents and update their knowledge. They participate in the prevention of poisoning and in public health education.
Each poison control centre operates under the responsibility of a university professor - hospital practitioner, or a university lecturer - hospital practitioner or a hospital practitioner with experie…
Depending on their size and the diversity of their activities, the centres are organised into services or departments, or into separate structures. They include an emergency response unit operating un…
The information system common to all poison control centres is that defined in article R. 1340-6.
Each centre draws up an annual activity report, including an assessment of its practices and organisation. This report is drawn up in accordance with the model defined by order of the Minister for Hea…
…centres are involved in toxicovigilance. Their toxicovigilance missions are defined in article R. 1340-5.
…t et du travail and the Agence nationale de sécurité du médicament et des produits de santé as part of the vigilance systems relating to the products mentioned in Articles L. 5311-1, L. 5141-1 and R.…
…with the authorities, with other poison control centres and with the body referred to in article L. 4411-4 of the Labour Code, and lines used for routine consultations or for routine operations, which…
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