Subsection 1: General provisions

For the purposes of this section, the following definitions shall apply

1° Incident: an accident or error related to activities involving gametes, germinal tissue or embryos mentioned in 1° of the I of article R. 2142-39, resulting in or likely to result in:

a) An adverse reaction in the persons mentioned in 3° of the I of article R. 2142-39 ;

b) A loss of these gametes, germinal tissues or embryos;

c) A quality or safety defect in these gametes, germ tissue or embryos;

2° Serious incident :

a) Any incident resulting in or likely to result in:

-a serious adverse reaction or an unexpected adverse reaction in the persons mentioned in 3° of the I of article R. 2142-39 ;

-any error in the allocation of gametes, germinal tissue or embryos mentioned in 1° of I of the same article;

-any significant loss of the same elements during medically assisted procreation;

b) Any abnormally high frequency of occurrence of incidents or expected adverse reactions;

c) Any information concerning the donor or the donation, even if discovered incidentally after collection, the consequences of which are likely to entail a risk to the health of persons who have recourse to a donation in the context of medically assisted procreation or who are the offspring of a donation in the context of medically assisted procreation;

d) Any information concerning the person born from a donation, even if discovered by chance, the consequences of which are likely to entail a risk to the health of the donor;

3° Adverse reaction: harmful reaction occurring in the persons mentioned in 3° of the I of article R. 2142-39 related or likely to be related to the gametes, germinal tissue or embryos mentioned in 1° of the I of this same article or to the activities mentioned in 2° of the same I;

4° Serious adverse reaction: an adverse reaction which has resulted in death or which has been life-threatening, disabling or incapacitating, or which has led to, or prolonged, hospitalisation or any other morbid condition;

5° Unexpected adverse reaction: a serious or non-serious adverse reaction, the nature, severity or evolution of which is not expected with regard to the criteria defined by the Agence de la biomédecine under the conditions provided for in 7° of Article R. 2142-43 or taking into account the state of health of the persons mentioned in 3° of I of Article R. 2142-39;

6° Surveillance: the fact that professionals involved in the activities mentioned in 2° of Article R. 2142-39 record all incidents and undesirable effects;

7° Reporting: the fact that professionals involved in the activities mentioned in 2° of article R. 2142-39 inform without delay the local correspondent for the vigilance system in medically assisted procreation of any serious incident or unexpected adverse reaction that they have identified in the context of their surveillance mission; 8° Declaration: the fact that professionals involved in the activities mentioned in 2° of article R. 2142-39 inform without delay the local correspondent for the vigilance system in medically assisted procreation of any serious incident or unexpected adverse reaction that they have identified in the context of their surveillance mission;

8° Declaration: the fact that local correspondents or, where applicable, any healthcare professional involved in the activities mentioned in 2° of Article R. 2142-39, inform the Agence de la biomédecine by means of the declaration mentioned in 9° of Article R. 2142-43 of information relating to serious incidents or unexpected adverse reactions enabling this Agency to implement the provisions set out in 3° and 4° of Article R. 2142-43 and Article R. 2142-44.