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Showing 3521–3530 of 25519 articles for “Art. IV bis”
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…
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…
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…
…set out in article 131-21 of the same code; 3° The permanent closure, or closure for a maximum of five years, of the establishments of the company that were used to commit the offence, under the cond…
…liament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC any suspected adverse reaction, in accordance with Article 76(2) of the same Regulati…
…d batch of veterinary medicinal products has undergone, in the European Union of a complete qualitative and quantitative analysis of at least all the active substances and has been subjected to all th…
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.
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