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Decision Dg No. 2012-51 April 12, 2012, Amending The General Organization Of The French Health Products Safety Agency

Original Language Title: Décision DG n° 2012-51 du 12 avril 2012 portant modification de l'organisation générale de l'Agence française de sécurité sanitaire des produits de santé

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JORF n°0135 of 12 June 2012 page 9901
text No. 8



Decision DG No. 2012-51 of 12 April 2012 amending the general organization of the French Health Products Agency

NOR: AFSX1225124S ELI: https://www.legifrance.gouv.fr/eli/decision/2012/4/12/AFSX1225124S/jo/texte


The Director General of the French Health Products Safety Agency,
Vu le Public Health Code, and in particular, book III of Part 5;
In view of the amended decision DG No. 99-40 of 12 July 1999 on the general organization of the French Health Products Safety Agency;
Considering the deliberation of the Board of Directors No. 2012-04 of 28 March 2012;
In light of the opinion of the technical committee on parity dated 13 March 2012,
Decides:

Article 1


Section 2 of the above-mentioned decision DG No. 99-40 of 12 July 1999 is amended as follows:
I. ― At the end of the first paragraph "The General Directorate understands:", two dashes are added:
“– the direction of strategy and international affairs;
― the ethics service of expertise".
II. ― At I, entitled "The Deputy Director General for Operations",
A. ― The terms:
"He is in charge:
to assist the Director General;
― to pilot and coordinate files involving scientific directorates and the department of legal and European affairs, which are directly linked to it;
– managing international and European relations;
- coordinating vigilance;
– managing relationships with learned societies;
― to cross-cuttingly pilot the support of innovation and NRBC coordination at the agency;
- managing relations with national defence;
– managing the scientific council. »
are replaced by the terms:
"He is in charge:
to assist the Director General;
― to pilot and coordinate files involving scientific directorates and the department of legal and European affairs, which are directly linked to it;
– managing relations with national defence. »
B. ― 3 and 4 are deleted.
III. – In II, entitled “The Assistant Director General for Resources”,
A. ― The terms:
"to manage the board of directors" are deleted.
B. ― 4 and 5 are deleted.
IV. ― After the III, an IV and a V are added:
"IV. – The direction of strategy and international affairs.
Rattachée to the Director General, she is responsible for:
– to establish the strategic priorities of the agency at the national, European and international level and its scientific policy;
– to ensure coordination and leadership of interactions with partner, national, European and international institutions;
– to coordinate the preparation and organization of governance bodies (administrative board and scientific board) and boards of the agency;
– managing relationships with scholarly societies.
This direction includes a director, an assistant director and four poles.
V. ― The ethics department of expertise.
Attached to the Director General, he is responsible for assisting the Director General and exercising the following tasks under his authority:
― contribute to the operation of the evaluation processes by carrying out a legal advisory and expertise mission both with the general management and with the services concerned to ensure compliance with the legislative and regulatory provisions surrounding the operation of the agency's advisory bodies;
―for this purpose, the service develops tools for the prevention and treatment of conflicts of interest and the steps to be taken to address the problems that they can cause;
- Conducting ethics information and training activities with external staff and experts;
– to provide its expertise to the legal and European affairs department for the development of all ethics texts and to ensure their integration into the organization and operation of the expertise process. It deals, in connection with this service, with contentious matters relating to issues of ethics and impartiality of the process of expertise within the agency;
- perform controls on the content of statements of interest, both agency staff and external experts, in particular in terms of consistency with available public information;
― to carry out an audit program of the various procedures established within the agency to ensure compliance with the ethical rules of internal and external expertise, which is presented annually to the ethics committee before being submitted to the board of directors;
animate the work and provide the secretariat of the Ethics Committee. »

Article 2


Section 11 of the above-mentioned decision DG No. 99-40 of 12 July 1999 is amended as follows:
I. ― In the second paragraph, the words: "He includes a chief of service, a deputy head of service and the ethics watch cell" are deleted.
II. ― The terms: "The deontological watch cell, attached to the person responsible for the service" to "help with the implementation of the internal deontological watch" are deleted.

Article 3


Articles 12 to 15 are deleted.

Article 4


This decision will be published in the Official Journal of the French Republic.


Done on 12 April 2012.


D. Maraninchi


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