Article D5125-45-1
…llary medicinal products authorised when used under the provisions of 1° or 2° of III of article L. 1121-16-1 may be dispensed by pharmacies, if they appear on the list referred to in the first paragr…
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Showing 131–140 of 187 articles for “Art. 1121”
…llary medicinal products authorised when used under the provisions of 1° or 2° of III of article L. 1121-16-1 may be dispensed by pharmacies, if they appear on the list referred to in the first paragr…
…aph are carried out as part of research involving the human person within the meaning of Article L. 1121-1, they are governed solely by the provisions of Title II of Book I of this Part relating to re…
The research referred to in 1° of Article L. 1121-1 relating to devices incorporating products of human or animal origin, or in the manufacture of which products of human or animal origin are involved…
…hat person is exposed for medical purposes or as part of the research mentioned in 1° of Article L. 1121-1.
…of carrying out or having carried out on a person the research mentioned in 1° or 2° of article L. 1121-1 or a clinical trial mentioned in article L. 1124-1 of the Public Health Code without having o…
…take the appropriate urgent safety measures. For the research mentioned in 2° and 3° of Article L. 1121-1, the provisions of this article only apply in the absence of provisions relating to vigilance…
…mans. II - Use for therapeutic purposes includes in particular the research mentioned in article L. 1121-1. In application of article L. 1245-4, the provisions of sub-sections 3 and 4 of this section…
…ency for the Safety of Medicines and Health Products for the research mentioned in 1° of Article L. 1121-1. The sponsor informs the competent authority and the Committee of any substantial changes mad…
For the research mentioned in 1° of Article L. 1121-1 other than that mentioned in Articles R. 1123-54 to R. 1123-58, the sponsor must report to the competent authority any suspected serious unexpecte…
…y medicinal products used in the context of research mentioned in the first paragraph of article L. 1121-1 are manufactured, imported, exported and distributed in accordance with the legislative and r…
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