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Showing 4381–4390 of 46956 articles for “Art. 219 I b”
The failure of a qualified person of a veterinary medicinal product manufacturing establishment referred to in Article 97 of Regulation (EU) 2019/6 of 11 December 2018 or of a person responsible for a…
A decree in the Conseil d'Etat shall determine the conditions under which one or more of the Agency's support and back-up services may be pooled with one or more services of other bodies pursuant to A…
Opening or operating an establishment defined in Article L. 5142-1, without the authorisation required pursuant to Articles 88 and 99 of Regulation (EU) 2019/6 of 11 December 2018 or without this havi…
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…
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