Article L5441-3
Failure by a sponsor, either within the two-month period preceding the clinical trial or when a substantial amendment to the trial is made, to send the Agency the information required by law relating…
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Showing 9921–9930 of 62389 articles for “Art. L 224-4 I”
Failure by a sponsor, either within the two-month period preceding the clinical trial or when a substantial amendment to the trial is made, to send the Agency the information required by law relating…
The following are punishable by two years' imprisonment and a fine of €30,000:1° Failure to prepare self-vaccines in compliance with the obligations set out in Article L. 5142-1-1;2° Failure to comply…
Natural persons guilty of the offences provided for in article L. 5441-8 are also liable to the following additional penalties: 1° Posting of the decision and its dissemination, under the conditions s…
Failure by the marketing authorisation or registration holder to report to the pharmacovigilance database referred to in Article 74 of Regulation (EU) 2019/6 of the European Parliament and of the Coun…
Manufacturers, importers and holders of veterinary medicinal products who fail to declare their production, import or stock at the express request of the authorities in the event of an epizootic disea…
Granting exclusive rights to sell veterinary medicinal products to one or more categories of reseller is punishable by a fine of €3,750.
Carrying out the non-clinical trials mentioned in article L. 5141-4 without complying with the good laboratory practice mentioned in the same article is punishable by a fine of 3,750 euros.
Public, private and community health establishments provide diagnosis, monitoring and treatment for the sick, injured and pregnant women, under the conditions set out in this code, taking into account…
As stated in the first paragraph of article L. 2223-39 of the French General Local Authorities Code, reproduced below: "Public or private health establishments that meet the conditions laid down by de…
The regulatory measures provided for in articles L. 6111-1 and L. 6111-4 shall be determined by decree in the Conseil d'Etat, as shall, where necessary, the procedures for applying the other provision…
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