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Showing 2851–2860 of 61379 articles for “Art. L 54-10-1”
Persons manufacturing or marketing the substances, plants, medicinal products and other products mentioned in article R. 5132-98 shall, at their request, provide the Director General of the Agence nat…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé provides all relevant information to the European Medicines Agency, as well as to the International Narc…
Any doctor, dental surgeon or midwife who becomes aware of a serious case of pharmacodependence, abuse or misuse of a substance, plant, medicinal product or other product mentioned in article R. 5132-…
The drug dependence and addictovigilance assessment and information centres carry out their vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
The principles of good veterinary pharmacovigilance practice to which veterinarians, pharmacists and members of the other health professions mentioned in 4° of article R. 5141-93 are subject are defin…
The declaration and reporting obligations laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulati…
The creation, organisation and funding of veterinary pharmacovigilance centres, as well as the conditions under which they carry out the tasks entrusted to them by the Agence nationale de sécurité san…
Where a medical device is not intended for use in a specific part of the body, it must be considered and classified according to the most critical use as specified. Where more than one rule applies to…
Any establishment mentioned in 4° of article R. 5222-3 and any blood transfusion establishment shall appoint a local reactovigilance correspondent.The local reactovigilance correspondent is a doctor o…
…e quantified either by a minimum and a maximum, or by an increase or decrease over the period of implementation of the plan, possibly accompanied by deadlines over all or part of this period.
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