Article L5321-1
The Agency is subject to an administrative, budgetary, financial and accounting system and to State control adapted to the specific nature of its mission, as defined in this Book and specified by decr…
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Showing 3581–3590 of 46024 articles for “Art. 990 I”
The Agency is subject to an administrative, budgetary, financial and accounting system and to State control adapted to the specific nature of its mission, as defined in this Book and specified by decr…
The agency's resources are made up of :1° A subsidy from the State ;2° Subsidies from other public authorities, their public establishments, social security bodies, the European Union or international…
I.-A fee is payable by the applicant for the performance by the Agency of the following operations: 1° Analysis of samples and evaluation of the documentation relating to the control protocol submitte…
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…
The following is punishable by two years' imprisonment and a fine of 150,000 euros:1° The fact, for the qualified person mentioned in II of Article L. 5142-1, of releasing a batch of veterinary medici…
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.
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