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Showing 811–820 of 4213 articles for “Art. CE 31 Mar 2017 n° 401059”
…icles L. 3212-1 and L. 3213-1 who do not come under the provisions of Article 64 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and persons admitted to a hea…
…nt authority; 2° Under conditions contrary to the provisions of article L. 1125-11; 3° The performance of which has been prohibited or suspended by the competent authority. Any investigator who carrie…
…e provisions of this chapter apply to clinical investigations which are classified as national defence secrets within the meaning of article 413-9 of the French Criminal Code.
…scheme or who is a beneficiary of such a scheme to take part in clinical investigations, with the exception of those which do not involve any risk or constraint and in which all the procedures are per…
…ed out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Clinical investigations in the field of midwifery may only be carried out under the direction an…
…g or having performed a clinical investigation 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 pun…
Once the Data Protection Committee has issued a favourable opinion and the investigation has been authorised by the Agence nationale de sécurité du médicament et des produits de santé, where applicabl…
…l apply to the clinical investigations provided for in paragraph 1 of Article 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
…obtained in writing under the conditions laid down in paragraph 1 of Article 63 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, after he has been given the…
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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