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Showing 3351–3360 of 69946 articles for “Art. L. 231-1 and L. 231-2”
Marketing authorisation holders and pharmaceutical companies exploiting medicinal products ensure an appropriate and continuous supply of the national market in order to cover the needs of patients in…
…Title II of Law No. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, as well as the provisions of Regulation (EU) 2016/679 of the European Parliament and o…
…hose civil liability is not covered by the insurance provided for in the third paragraph of article L. 1125-9 shall be punished by one year's imprisonment and a fine of 15,000 euros.
…nical investigations falling into one of the categories mentioned in the first paragraph of article L. 5126-7 is punishable by a fine of 30,000 euros.
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulti…
…clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the sponsor to provide the…
…y considers that the requirements set out in Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 are not being met, it may at any time request that changes be mad…
Failure to comply with paragraph 1 of Article 77 and paragraph 2 of Article 80 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the communication of inform…
…estigation in breach of Articles 63 to 66 of Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 and Article L. 1121-6, is punishable by three years' imprisonment…
Pursuant to Articles 62,70,74,75 and 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, before carrying out a clinical investigation, the sponsor shall submi…
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