Chapter I: Missions.

In order to carry out its duties, the Agency :

1° Carry out or arrange for the carrying out of any expert appraisal or technical inspection relating to the products and articles mentioned in Article L. 5311-1, the substances of which they are composed and the methods and means of manufacture, packaging, preservation, transport and control applied to them; it carries out quality control of medical biology examinations and analyses enabling a person to be identified by genetic fingerprints and, at the request of the departments concerned, provides any necessary technical expertise; it may be responsible for quality control of activities using products falling within its field of competence;

2° Collects the scientific and technical data necessary for the performance of its duties; it is the addressee of inspection and review reports and expert reports produced in its area of competence by State departments or by the public establishments attached to it; it evaluates the information it collects as part of the vigilance systems it implements for the products mentioned in II of Article L. 5311-1, with the exception of biovigilance and the vigilance system relating to medically assisted procreation, as well as on the abuse and drug dependence likely to be caused by psychoactive substances, and takes, in this area, within its remit, any useful measures to protect public health;

3° Provides the Ministry of Health with the expertise it requires in relation to the above-mentioned products, in particular to ensure their proper use; participates in the preparation of legislation and regulations; proposes to the Ministry of Health and the Ministry of Social Security any measures within their remit; provides the scientific and technical support required for the preparation and implementation of public health plans;

4° Participates in France's European and international activities;

5° For the implementation of 1° to 4°, requests, for analysis purposes and for justified reasons, the transmission free of charge of samples of products and objects mentioned in Article L. 5311-1 ;

6° Promotes research, ensures coordination and, where appropriate, sets up patient follow-up studies and the collection of efficacy and safety data, in particular by means of agreements;

7° Has access, at its request and under conditions that preserve the confidentiality of the data with regard to third parties, to the information necessary for the performance of its duties that is held by any natural or legal person, without being able to invoke medical secrecy, professional secrecy or business secrecy.