Key Benefits:
Director General of the National Drug and Health Products Safety Agency,
Vu le Public Health Codearticles L. 5311-1 et seq. and R. 5322-14;
Vu la Act No. 2011-2012 of 29 December 2011 on strengthening the health safety of the drug and health products;
Vu le Decree No. 2012-597 of 27 April 2012 the National Drug Safety Agency and Health Products;
Having regard to the decree of May 1, 2012 appointing the Director General of the National Agency for the Safety of Medicine and Health Products - Mr. Maraninchi (Dominique);
Having regard to Decision DG No. 2012-237 of 24 September 2012 organizing the National Drug Safety Agency and Health Products;
Having regard to Decisions DG No. 2012-238 of 24 September 2012 and DG No. 2012-248 of 7 November 2012 appointing the National Drug and Health Products Safety Agency;
In view of Decision DG No. 2012-239 of 24 September 2012 with delegation of signature at the National Drug and Health Products Safety Agency,
Decides:
Decision DG No. 2012-239 of September 24, 2012 with delegation of signature to the National Agency for the Safety of the Drugs and Health Products referred to above is amended as follows:
I. - The third of Article 10 is as follows:
"III. ― Permanent Delegation is given to Ms. MONTANIER (Florence), an evaluator pharmacist within the regulatory branch, to the effect of signing, on behalf of the Director General of the National Agency for the Safety of Medicine and Health Products, decisions relating to the IA amendments to the marketing authorizations (AMM), the transfer decisions of the MMAs and the amendments to an operator change. »
II. ― Section 12 is amended as follows:
"III. ― Permanent Delegation is given to Mr. RIBES (Olivier), Head of the Biological Products Inspection Unit, Mr. RENAUD (Guillaume), Head of the Primary Material Inspection Unit, and Mr. BORN (Jean-Christophe), Head of the Market Surveillance Inspection Unit, on behalf of the Director General of the National Drug Safety Agency and Health Products Agency, all decisions within the limit of their respective responsibilities.
IV. ― Permanent Delegation is given to Mr. VIORNERY (Lionel), Head of the Pharmaceutical Inspection Unit and Counter Fraud Control 1, and to Ms. RIBEIRO (Virginie), Head of the Pharmaceutical Inspection Unit and Counter Fraud Control 2, to sign, on behalf of the Director General of the National Drug and Health Products Safety Agency, all decisions within the limits of the duties of the two pharmaceutical companies.
V. - Permanent Delegation is given to Ms. RORIVE (Céline), Inspector, and Ms. HOLTZHEYER (Hélène), Assessor at the Pharmaceuticals Inspection and Fraud Control Unit 1, on behalf of the Director General of the National Agency for Safety of Medicine and Health Products, all decisions within the scope of the duties of the two Pharmaceuticals Inspection Poles and to combat fraud 1
VI. ― Permanent delegation is given to Mr. STERN (Cyril), Mr. HAAG (Jean-Claude), Mr. PALLUY (Olivier) and Mr. HESTERS (Rémi), inspectors at the biological inspection pole, Mr. MONTEIL (Thierry), inspector at the inspection pole of raw materials, Mr. PIAT (Olivier) and Ms. PICOT (Vaness) »
III. - Article 13 I, II and III are thus written:
"I. ― Permanent Delegation is given to Ms. FALIP (Evelyne), Director, Mr. BRUNEAUX (François) and Mr. MAISON (Patrick), Deputy Directors, to sign, on behalf of the Director General of the National Agency for the Safety of Medicine and Health Products, all decisions within the limits of the responsibilities of the supervisory management and the authorizations for the importation of drugs issuedArticle L. 5124-6 of the Public Health Code.
II. ― Permanent Delegation is given to Mr. ZUREIK (Mahmoud), Head of the Epidemiology Trade Point of Health Products, to Ms. SAILLY (Anne-Charlotte), Head of the Materials, Reactovigilance, Cosmetovigilance, Hemovigilance, Biovigilance, and to Ms. CARDONA (Florence), Head of the Pharmacovigilance, addictovigilance
III. ― Permanent Delegation is given to Ms. DEBOURGES (Dominique), Head of the Market Control Pole, to the effect of signing, on behalf of the Director General of the National Drug Safety Agency and Health Products, all decisions within the limits of the duties of her pole and the authorizations for the importation of drugs issued in the context of stock breaks referred to in theArticle L. 5124-6 of the Public Health Code. »
IV. ― Article 14 IV and V are thus written:
"IV. ― Permanent delegation is given to Ms. GARCIA (Dominique), a scientist at the batch release and market surveillance cluster for biological products, to sign, on behalf of the Director General of the National Drug Safety Agency and Health Products, any decisions relating to the release of batches of immunological drugs made in accordance withArticle R. 5121-39 of the Public Health Code.
V. - Permanent Delegation is given to Ms. LIEVRE (Valérie), a scientist at the Batch Release and Market Surveillance Unit for Biological Products, to sign, on behalf of the Director General of the National Drug Safety Agency and Health Products, any decisions relating to the release of lots of blood-based medicines made in accordance withArticle R. 5121-40 of the Public Health Code. »
This decision will be published in the Official Journal of the French Republic.
Done on 9 November 2012.
D. Maraninchi
