If no response is received by the end of the period for examining the application for authorisation referred to in Article R. 1125-17 , this shall be deemed to constitute rejection. Silence on the expiry of the time limit for examining the application for substantial modification referred to in article R. 1125-20 also constitutes rejection.
For the purposes of this sub-section, the following definitions shall apply 1° Adverse event: any harmful manifestation occurring in a donor, in a person who takes part in research involving the human person carried out within the framework of medically assisted procreation or in a child born or to be born as a result of this medically assisted procreation, whether or not this manifestation is linked to the research or…
The sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reactions and any serious incidents occurring in France and outside national territory, and to the relevant Committee for the Protection of Individuals those occurring in France during the course of the research, without delay and at the latest within seven days of becoming aware of them. Relevant additional…
The sponsor reports every six months to the Data Protection Committee, in the form of a list accompanied by a summary, any suspected serious unexpected adverse reactions and serious incidents that have occurred in other research that it is conducting in France, or that have occurred outside national territory. The sponsor sends a copy of the six-monthly report mentioned in the previous paragraph to the Director General of the Agence…
The sponsor shall transmit to the investigators concerned any information likely to affect the safety of the donor, the person undergoing medically assisted procreation or the child born or to be born.
The investigator notifies the sponsor of all serious adverse events and serious incidents without delay after becoming aware of them. This notification is the subject of a written report and is followed by further detailed written reports. The investigator notifies the sponsor of adverse events and abnormal test results defined in the protocol as relevant to the evaluation of the safety of the donor, the person undergoing medically assisted reproduction…
Research relating to national defence secrets is not subject to the provisions of this Title, with the exception of sections 1 to 4 of Chapter I and Chapter II.
The examination of a person’s genetic characteristics or their identification by genetic fingerprinting for medical purposes consists of analysing their genetic characteristics inherited or acquired at an early stage of prenatal development. The purpose of this analysis is: 1° Either to establish, confirm or invalidate the diagnosis of a genetic disease in a person; 2° Or to search for the characteristics of one or more genes likely to be at…
The following constitute analyses for the purpose of determining a person’s genetic characteristics or identification by genetic fingerprinting for medical purposes: 1° Cytogenetic analyses, including molecular cytogenetic analyses; 2° Molecular genetic analyses; 3° Any other medical biology analysis prescribed with the intention of obtaining information for determining the genetic characteristics of a person equivalent to that obtained by the analyses mentioned in 1° and 2° above. These analyses are listed…
The prescription and performance of an examination of a person’s genetic characteristics for medical purposes, as well as the specific procedures for appropriate genetic counselling, are subject to rules of good practice defined by order of the Minister for Health, issued on a proposal from the Director General of the Agence de la biomédecine after receiving the opinion of the Agence nationale de sécurité du médicament et des produits de…
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75001, Paris France
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