Article R1125-10
…the Agence nationale de sécurité du médicament et des produits de santé considers that additional information, consultations or specific studies are required to enable him to reach a decision on the a…
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Showing 7491–7500 of 17465 articles for “Art. Form 2044 spéciale”
…the Agence nationale de sécurité du médicament et des produits de santé considers that additional information, consultations or specific studies are required to enable him to reach a decision on the a…
…te a refusal of the application on expiry of a period of thirty-five days from receipt of all the information required concerning the amendment application. If the Director General considers that addi…
Research involving the following products is subject to express authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Organs and tissue…
Annex II of Regulation (EC) 1223/2009 setting out the list of substances that may not be used in cosmetic products is applicable to the composition of cosmetic products used in research involving the…
…the sponsor of any objections to the implementation of the research in a reasoned letter. He will inform the relevant personal data protection committee. It sets a deadline for the sponsor to submit i…
The provisions of articles…
…o decides on the admissibility of the application, ensuring that the application contains all the information. He will acknowledge receipt to the sponsor and notify him of the date of receipt of the a…
When the application concerns the organs and tissues of human or animal origin mentioned in 1° and 6° of Article R. 1125-7, and the cell therapy preparations mentioned in 2° of Article R. 1125-7 as we…
I. - The articles L. 5214-26 to L. 5214-29 are applicable in French Polynesia subject to the adaptations provided for in II.II. - For the application of'article L. 5214-28 :1° The sentence: " b) Or wh…
Each doctor or nurse regularly required or commissioned receives remuneration or fees calculated by reference to the conventional fee rates set on the basis of article L. 162-14-1 of the Social Securi…
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