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Showing 4931–4940 of 20783 articles for “Art. CE 17-5-1999 n° 188870”
…without the authorisation required pursuant to Articles 88 and 99 of Regulation (EU) 2019/6 of 11 December 2018 or without this having been renewed in the event of a change to the elements included in…
Failure by any person exploiting a medicinal product or product to notify the Agence nationale de sécurité du médicament et des produits de santé of any prohibition or restriction imposed by the compe…
…e market, within the meaning of article L. 513-10-2, to report serious adverse reactions to the Agence nationale de sécurité du médicament et des produits de santé as soon as they become aware of them…
Anyone found to be in possession of falsified raw materials for pharmaceutical use without a legitimate reason is liable to three years' imprisonment and a fine of €75,000.Where the falsified raw mate…
Failure by the operator to subject a device mentioned in Article 1 of Regulation (EU) 2017/745 to maintenance obligations and quality controls pursuant to Article L. 5212-1 is punishable by two years'…
…lly liable, under the conditions set out in article 121-2 of the French Criminal Code, for the offences defined in this chapter shall incur, in addition to the fine set out in article 131-38 of the Fr…
…a fine of €150,000:1° Subject to medical prescription ;2° Reimbursable by compulsory health insurance schemes, except in the case provided for in the third paragraph of article L. 5122-6 ;3° Whose ma…
For a manufacturer, agent, distributor or importer of a device referred to in Article 1 of Regulation (EU) 2017/746 to carry out, cause to be carried out, disseminate or cause to be disseminated adver…
The procedures for applying the provisions of this chapter shall be determined by decree in the Conseil d'Etat.
…alth so require, order the temporary closure of the establishment.Natural persons guilty of an offence under this chapter shall incur the additional penalty of temporary or permanent closure of the es…
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