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Showing 9681–9690 of 69024 articles for “Art. L. 221-8 + Art. R. 221-30 à R. 221-37”
…lating to these gametes, germ tissue and embryos as implemented by the persons mentioned in Article L. 2142-1 ;3° Persons who have recourse to medically assisted procreation or are the result of such…
The purpose of vigilance in medically assisted procreation is to : 1° Systematically monitor all incidents and undesirable effects; 2° Report serious incidents and unexpected undesirable effects to th…
…sion within ninety days from the date of receipt of the application accompanied by a complete dossier.The Director General may request any additional information or carry out an investigation to enabl…
…Third parties and agreements entered into with these third parties as provided for in 5° of Article R. 4211-34. 4211-34. Within one month of their implementation, changes are declared to the Agence na…
…s prepared on an ad hoc basis in accordance with the rules of good practice provided for in Article L. 5121-5 and including a description of the responsibilities and measures to be taken. The responsi…
…onale de sécurité du médicament et des produits de santé and to the inspectors mentioned in article L. 5313-1.
…red on an ad hoc basis in compliance with the health safety rules adopted in application of Article L. 1211-6, prepared in accordance with the rules of good practice provided for in Article L. 5121-5…
Changes other than those mentioned in articles R. 4211-43 and R. 4211-44 are declared in the annual activity report provided for in article R. 4211-47.
In the event of non-compliance with the legislative and regulatory provisions or the conditions of the authorisation, the suspension, which may not exceed one year, and the withdrawal of the authorisa…
The authorised establishment or body sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Agence de la biomédecine, as…
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