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Information in English

Information in English

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ANSM

ANSM - Organizational chart (15/12/2017)  (593 ko)
ANSM - Annual report 2016 (08/09/2017)  (2851 ko)
ANSM - Annual report 2015 (29/12/2016)  (2825 ko)
ANSM - Annual report 2014 (09/10/2015)  (2395 ko)
ANSM - Presentation brochure (04/09/2015)  (176 ko)
ANSM - Annual report 2013 (06/11/2014)  (3479 ko)
Receipt deposit slip (16/09/2013)  (188 ko)
Taxes subject to payment of a registration fee collection of taxes in 2012 (13/06/2012)  (66 ko)
The transfer of payments from the ANSM to the State - 2012 (13/06/2012)  (521 ko)
   

Blood and blood products

How to improve the quality of the transfusion chain : factsheets and “guidelines” available and used by the french haemovigilance network - Scientific Poster (25/03/2016)  (191 ko)
French IT system for reporting adverse reactions and events in haemovigilance- Scientific Poster (25/03/2016)  (334 ko)
How to react quickly in front of epidemiological alerts : application to Zika alert by the french advisory group - Scientific Poster (25/03/2016)  (114 ko)
Investigation of Grade ≥ 2 allergic Recipient Adverse Reactions (RAEs) (18/06/2012)  (91 ko)
2009 - Annual Haemovigilance report (12/04/2011)  (575 ko)
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2008 - Annual Haemovigilance report (04/01/2010)  (437 ko)
Investigation of a suspicion of Transfusion Transmitted Bacterial Infection: The French experience (04/05/2009)  (792 ko)
2004 - Annual Haemovigilance report - Abstract (24/07/2005)  (63 ko)
Evaluation of the risk of transmission of Creutzfeldt-Jakob agent by blood and its constituents (28/02/2005)  (137 ko)
2002 - Annual Haemovigilance report (01/09/2004)  (1081 ko)
Analysis of the risk of transmission of variant of creutzfeldt-jakob disease by health products and by tissues and fluids of human origin - Update of findings of ad hoc group report of december 2000 (03/02/2004)  (144 ko)
2001 - Annual Haemovigilance report (03/04/2003)  (1073 ko)
Analysis of the risk of transmission of the variant creutzfeldt-jakob disease by medicinal products of human origin and labile blood products: Data update of the ad hoc group reportdated december 2000 (03/03/2003)  (258 ko)
Analysis of the risk of transmission of the variant Creutzfeldt-Jakob Disease by medicinal products of human origin and labile blood products : Data update of the ad hoc group report dated December 2000 (03/02/2002)  (191 ko)
   

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3rd complication case in DICS X genetherapy clinical trial (24/01/2003)  (46 ko)
Severe Combinated Immuno-Deficiency (15/01/2003)  (9 ko)
Severe Combined Immuno-Deficiency : clinical trial put on hold (03/10/2002)  (218 ko)
 

Cosmetics

SUE Form A - Notification of SUE by responsible person or ditributor to competent authority (28/10/2013)  (128 ko)
Risk assessment related to the use of aluminum in cosmetic products (17/11/2011)  (80 ko)
   

Drugs

Clinical Drug Trials submitted within the Pilot Phase to ANSM (French National Agency for Medicines and Health Products Safety) and the CPP (French Ethics Committee) -Practical Information Guide for Applicants (26/06/2018)  (758 ko)
CSST “Evaluation of the benefit/risk ratio of the use of baclofen in alcohol-dependent patients” - 04/17/2018 - Statement of opinion (24/04/2018)  (209 ko)
Déclaration d’exportation initiale (DEI) - Déclaration d’exportation complémentaire (DEC) / Initial export statement (IES) - Additionnal export statement (AES) - Formulaires/Forms (19/04/2018)  (61 ko)
Electronic transmission of individual case safety reports (ICSRs) with ANSM - Pharmacovigilance information for pharmaceutical companies (06/03/2018)  (140 ko)
Set up of Unit in charge of “Early phase Clinical Trials” - Information to clinical trials sponsors (08/12/2017)  (78 ko)
Antidepressants and hepatotoxicity: a cohort study among 5 million individuals registered in the french national health insurance databases - Scientific poster (17/10/2017)  (97 ko)
Comparison of data-mining methods for signals detection on a national and european spontaneous reporting databases - Scientific poster (17/10/2017)  (108 ko)
Robustness of the CPA-PRR method in pharmacovigilance detection - Scientic poster (17/10/2017)  (69 ko)
Enforcement of the European regulation on clinical trials on medicinal products: assessment eighteen months into the pilot phase - Information bulletin (22/06/2017)  (56 ko)
Scientific Advice for medicinal products in ANSM (11/05/2017)  (165 ko)
Enforcement of the European regulation on clinical trials on medicinal products : assessment one year into the pilot phase (25/01/2017)  (44 ko)
Situation report on the active substance amoxicillin (26/09/2016)  (239 ko)
Report by the Temporary Specialist Scientific Committee (TSSC), "FAAH (Fatty Acid Amide Hydrolase)", on the causes of the accident during a Phase 1 clinical trial in Rennes in January 2016 (25/04/2016)  (305 ko)
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Enforcement of the european regulation on clinical trials on medicinal products : assesment six months into the pilot phase - Information bulletin (19/04/2016)  (128 ko)
Temporary Specialist Scientific Committee on inhibitors of the FAAH (Fatty Acid Amide Hydrolase)- 03/31/2016 - Summary of conclusion (06/04/2016)  (224 ko)
Study of compliance with the isotretinoin pregnancy prevention programme regarding pregnancy testing in France using the EGB database - Scientific Poster (25/03/2016)  (112 ko)
Management of medication errors / overdosage with paracetamol (acetaminophen) in France - Scientific Poster (25/03/2016)  (445 ko)
Minutes of the Temporary Specialist Scientific Committee (TSSC) meeting on "FAAH (Fatty Acid Amide Hydrolase) Inhibitors" of 15 February 2016 (08/03/2016)  (195 ko)
Information bulletin - Rennes clinical trial - information on studies carried out on animals (29/02/2016)  (69 ko)
Temporary Specialist Scientific Committee on inhibitors of the FAAH (Fatty Acid Amide Hydrolase) - Summary of conclusion (17/02/2016)  (35 ko)
Information bulletin - Rennes clinical trial: the ANSM is pursuing its investigations (05/02/2016)  (172 ko)
BIAL Laboratory Clinical Trial BIA-102474-101:Publication of the Clinical Protocol (22/01/2016)  (41 ko)
Premature discontinuation of a BIAL laboratory clinical trial (21/01/2016)  (157 ko)
Impact of the sharp changes in the use of contraception in 2013 on the risk of pulmonary embolism in France - Scientific Poster (15/09/2015)  (246 ko)
Relationships between total hip replacement characteristics and three-year prostethic survivorship in 100 191 patients : a population-based study - Scientific Poster (15/09/2015)  (123 ko)
Notice to applicants for marketing for Temporary Authorisation for Use (ATU) (05/08/2015)  (981 ko)
Application of the Regulation (EU) on clinical trials on medicinal products: ANSM to implement a pilot phase - Information update (14/04/2015)  (120 ko)
The ANSM (French National Agency for Medicines and Health Products Safety) has suspended 25 medicines marketed in France following an inspection - Information (08/12/2014)  (312 ko)
Estimate of the number of venous thromboembolisms and related-deaths attributable to the use of combined oral contraceptives in France - Scientific Poster (03/11/2014)  (185 ko)
The use of oral isotretinoin in France : assesment of appropriate use as a second line treatment - Scientific Poster (03/11/2014)  (104 ko)
Compliance with pregnancy prevention recommendations in 7,663 french women of childbearing age exposed to acitretin - Scientific Poster (03/11/2014)  (190 ko)
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Clarification concerning the good use of drugs in the event of a heat wave - Key messages (13/06/2014)  (95 ko)
Clarification on the conservation of drugs in the event of a heat wave (13/06/2014)  (96 ko)
Clinical Trial Facilitation Group (CFTG) - Question and answers to the safety in clinical trials (04/03/2014)  (42 ko)
Temporary Recommendation for Use (RTUs) - Principles and information on the methods used by the ANSM for establishment and implementation (17/01/2013)  (175 ko)
Use of Medications Containing Pioglitazone (Actos®, Competact®) Suspended - Press release (17/06/2011)  (96 ko)
Prophylaxis of conjunctival infections in newborn infants - Update (28/02/2011)  (46 ko)
“From Pharmacovigilance to risk management” - 9th ISOP-Opening Session speech (07/10/2009)  (54 ko)
List of essential medicinal products in the context of a pandemic emergency (french national recommendations) (07/09/2009)  (224 ko)
Tamiflu®/ Relenza® and Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency (29/07/2009)  (60 ko)
Medicinal products and driving (02/07/2009)  (187 ko)
Risk management activity at Afssaps : Organisation, functioning, partnerships and developments (31/03/2009)  (199 ko)
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Evaluation and management of psychiatric disorders in adult patients infected by hepatitis C virus and treated with (peg) interferon alfa and ribavirin - Recommendation (04/07/2008)  (278 ko)
Medical follow up of patients with asthma -adults, adolescent (18/09/2004)  (119 ko)
 

Forms- Administrative procedures

Submission of European Active Substance Master File (ASMF) - Form (11/01/2018)  (27 ko)
Submission of confidential file for the active substance (or the "European Active Substance Master File (ASMF)") to ANSM - Instructions (27/12/2017)  (124 ko)
Creation of generic groups for herbal medicinal products in the list of generic groups - Notice to applicants (18/12/2017)  (53 ko)
Annual update of pharmaceutical sites- Version bilingue (16/01/2017)  (2100 ko)
Explanatory note Clinical Trial Vigilance Data Reporting (SUSARs)  (11/08/2016)  (138 ko)
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Form for receipt of the fee following the performance of a requested inspection (15/10/2015)  (51 ko)
Identification Form to append to any correspondence or submission in the context of MA (11/09/2014)  (50 ko)
Submission of Risk Minimisation Plans to Ansm (17/10/2013)  (57 ko)
Clinical trials : Multiple Intermediary Letters (MIL) procedure - Version n° 1 - August 2010 (09/08/2010)  (37 ko)
Schema for initial incidents for EU vigilance exchange (16/07/2010)  (23 ko)
Schema for combined initial and final Incidents for EU vigilance exchange (16/07/2010)  (23 ko)
Schema for follow up Incidents for EU vigilance exchange (16/07/2010)  (23 ko)
Schema for final incidents for EU vigilance exchange (16/07/2010)  (23 ko)
Marketing authorization presentation codes - Notice to human-use medicinal product marketing authorization holders and head pharmacists of the pharmaceutical establishments (27/01/2010)  (37 ko)
Conduct of clinical trials on medicinal products for human use in France - notice to sponsors of clinical trials on medicinal products - practical documents / substantial amendments (01/01/2009)  (195 ko)
Formulaire de demande de renseignement dossier AMM - questions administrative ou réglementaires / Information Form regarding Marketing Authorisation Applications - administrative or regulatory query (13/05/2008)  (39 ko)
Notice to human-use medicinal product marketing authorization holders and head pharmacists of the pharmaceutical establishments cited in article R. 51242 of the French Public Health Code (CSP) (21/02/2007)  (268 ko)
Information for pharmaceutical companies - Electronic exchanges of individual case safety reports (ICSRs) with Afssaps (12/12/2006)  (26 ko)
Scientific advice and protocol assistance meeting requests at Afssaps (11/09/2006)  (33 ko)
Fiche CIOMS/ CIOMS form (29/08/2001)  (13 ko)
 

Piratox / Piratome sheets

Introduction to Piratox and Piratome sheets (26/01/2012)  (42 ko)
Piratox Sheet 1 - "Cyanides and cyanide derivatives" (26/01/2012)  (229 ko)
Piratox sheet 2 - "Hydrogen arsenide or arsine" (26/01/2012)  (59 ko)
Piratox sheet 3 - "Lewisite" (26/01/2012)  (79 ko)
Piratox sheet 4 - "Organophosphates: neurotoxic weapons and pesticides" (26/01/2012)  (184 ko)
Piratox sheet 5 - "Suffocating agents and phosphine (26/01/2012)  (99 ko)
Piratox sheet 6 - "Yperite and other vesicant mustard agents" (06/06/2016)  (92 ko)
Piratome sheet 1 - "Treatment principles and choice of antidotes" (26/01/2012)  (81 ko)
Piratome sheet 2 - Prussian blue (23/01/2012)  (71 ko)
Piratome sheet 3 - DMSA – BAL (26/01/2012)  (95 ko)
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Piratome sheet 4 - Ca-DTPA (26/01/2012)  (112 ko)
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In vitro medical device

Market control based on package leaflets of serology reagents for the Lyme borreliosis (11/05/2017)  (113 ko)
Market surveillance - Rapid diagnostic tests for influenza (23/10/2013)  (9 ko)
Summary of the characteristics of a device (MD or IVD) (10/09/2013)  (517 ko)
Notice for sponsors - The installation and control in France of clinical trials relating to medical devices and in vitro diagnostic medical devices (30/07/2013)  (660 ko)
Blood Glucose Meters - European Co-ordinated Post Market Surveillance Operation under COEN authority - Report (25/10/2010)  (264 ko)
Current regulatory framework of in vitro diagnostic medical devices, perspectives and Afssaps’s innovation policy - International Biomarkers Conference on Rare, Polyfactorial and Neglected diseases, Dec 2009 (15/01/2010)  (364 ko)
Market surveillance 2005-2006 of screening and assay reagents for total antibodies directed against the hepatitis A virus (HAV) - Abstract (01/12/2007)  (89 ko)
Market Control 2004-2006 of screening and quantification devices for anti-HBs antibodies - Abstract (23/11/2007)  (65 ko)
Market surveillance (2006/2007) of MUC-1/CA 15-3 in vitro medical devices in vitro - Abstract (13/11/2007)  (55 ko)
Market surveillance 2005-2006 of instruction for use of Cortisol in vitro diagnostic medical devices - Abstract (14/11/2006)  (55 ko)
Market surveillance - Estradiol assays - Abstract (01/11/2006)  (152 ko)
HbA1c reagents : Instructions for use /guidelines - Abstract (10/01/2006)  (191 ko)
Market surveillance 2004- 2005 of instruction for use of growth hormone (GH) in vitro diagnostic medical devices - Abstract (28/07/2005)  (107 ko)
   

Medical devices

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Cardiotoxicity of metallic hip implants analysis of the french national health insurance databases (SNIIRAM) - Scientific poster (17/10/2017)  (90 ko)
Total hip arthroplasty with metallic bearing and risk of non-hodgkin’s lymphoma – data of the french national health insurance databases (SNIIRAM) - Scientific poster (17/10/2017)  (69 ko)
Heart valves for the new endovascular and transapical approaches (Aortic and pulmonary transcatheter bioprosthetic valves) - Report (24/08/2017)  (542 ko)
Denotification or termination of notified bodies’ activities - Information (14/11/2016)  (54 ko)
Labelling relative to phthalates in a medical device - Notice to manufacturers (11/10/2016)  (426 ko)
Market surveillance of PVC medical devices presented DEHP-free - Report (11/10/2016)  (417 ko)
Study on safety of medical devices software (13/07/2016)  (2111 ko)
Temporary Specialist Scientific Commity "Breast implant biocompatibility evaluation strategy" - 03/15/2016 -Meeting minutes (06/07/2016)  (193 ko)
Temporary Specialist Scientific Commity "Breast implant biocompatibility evaluation strategy" - 02/01/2016 -Meeting minutes (06/07/2016)  (210 ko)
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Guideline for demonstrating textured breast implant biocompatibility (06/07/2016)  (59 ko)
Implantable defibrillation leads - Inspection campaign summary report (19/05/2016)  (228 ko)
Decision of 10/09/2015 setting out the specific conditions for the placing on the market and distribution of certain medical devices sterilised using ethylene oxide - Framework and implementation modalities (19/02/2016)  (366 ko)
Ethylene oxide-sterilised medical devices in neonatology and paediatrics: Implementation of standard NF EN ISO 10993-7 (13/10/2015)  (203 ko)
Medical devices sterilized with ethylene oxide and used in neonatology and paediatrics - Summary of Regulations (23/07/2014)  (113 ko)
Evaluation of the use of silicone breast implants (other than PIP) in France 2010-2013 - Report (02/06/2014)  (334 ko)
Notice for sponsors - The installation and control in France of clinical trials relating to medical devices and in vitro diagnostic medical devices (30/07/2013)  (660 ko)
Form 5 - Vigilance report: initial report (30/07/2013)  (185 ko)
Form 6 - Vigilance report: additional information, follow-up data (30/07/2013)  (50 ko)
Pilot phase relative to the declaration of serious adverse events occurring during biomedical research concerning a medical device (30/07/2013)  (181 ko)
PIP Breast Implants Situation update -Report (11/06/2013)  (269 ko)
Update on checking procedures performed by the health authorities on the poly implant prothèse company (18/10/2012)  (1269 ko)
Situation update of the controls regarding the Poly Implant Prothèse Company performed by the health authorities – Executive summary (18/10/2012)  (175 ko)
Topical Report on Injectable wrinkle fillers (15/10/2012)  (439 ko)
New information about a case of breast cancer (adenocarcinoma) in a woman using prefilled, silicone gel PIP breast implants (08/12/2011)-Letter to healthcare professionnals (31/01/2012)  (73 ko)
New information about a case of breast cancer (adenocarcinoma) in a woman using prefilled, silicone gel PIP breast implants (31/01/2012)  (48 ko)
News Update on PIP Breast Implants - FAQ (31/01/2012)  (250 ko)
Important information on the monitoring of women who have breast implants prefilled with PIP silicone gel (23/12/2011) - Letter to healthcare professionals (31/01/2012)  (39 ko)
Useful information for women with PIP (Poly Implant Prosthèse) breast implants-FAQ (31/01/2012)  (119 ko)
Proposed measures to be taken for women with PIP breast implants: Experts' opinion Coordinated by the National Cancer Institute (INCA)  (31/01/2012)  (151 ko)
Update of recommandations for women with silicone filled PIP - Press release of Minister for Labour, Employment and Health (23/12/2011)  (47 ko)
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Topical report on PIP silicone gel-prefilled implants (29/06/2011)  (189 ko)
Breast implants with silicone based gel filling from Poly Implant Prothèse Company - Update of tests results (15/04/2011)  (64 ko)
Silicone filled breast implants from Poly Implant Prothèse Company Tests results - press release (28/09/2010)  (658 ko)
Decision determining specific conditions of use, putting into service, placing on the market, distribution, import and export, for the reinforcement of the safety of the children put in medical beds equipped with bed rails, (08/09/2010)  (33 ko)
Correct use of bed rails (11/08/2010)  (254 ko)
Risk of entrapment of "big children" in medical bed rails - Notice to manufacturers (28/07/2010)  (115 ko)
Medical "cot-beds" - regulations for manufacturing, import, export, marketing (free or for a price) and use (28/07/2010)  (26 ko)
Information for women with PIP breast implants -Questions/answers (26/07/2010)  (99 ko)
Silicone gel breast implants from Poly Implant Prothèse (PIP) Company - Information (26/07/2010)  (46 ko)
Silicone filled breast implants manufactured by POLY IMPLANT PROSTHESE (PIP (01/04/2010)  (60 ko)
List of essential medical devices in the event of a major health crisis: influenza pandemic scenario (11/12/2009)  (456 ko)
Instructions for use (IFU) for medical devices (02/12/2009)  (25 ko)
Post CE marketing market survey : the French experience on peracetic acid products used for material devices manual disinfection (juillet/04) - Competent authorities meeting on medical devices - Rotterdam (23/04/2008)  (71 ko)
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Compatibility between medical devices (11/07/2007)  (152 ko)
Guidelines on instruction for use of Troponin I/T cardiac marker devices (03/10/2006)  (53 ko)
Recommendations on evaluation of Troponin I/T cardiac marker devices (03/10/2006)  (35 ko)
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Forms - Administrative procedures

Application form for a consultation by a notified body on an ancillary medicinal substance integrated in a medical device/Formulaire de demande d'avis (18/10/2012)  (1045 ko)
Consultation on an ancillary medicinal substance integrated in a medical device : Notified body decision / Formulaire de décision de l'organisme notifié (18/10/2012)  (4573 ko)
Consultation on an ancillary medicinal substance integrated in a medical device : Documentation requirements /Structure du dossier à présenter (11/09/2012)  (155 ko)
Procedure to allow delivery of non Class III separated elements articular prosthesis to partial replacements (21/06/2012)  (400 ko)
Formulaire de signalement de matériovigilance/réactovigilance et rapport fabricant - Report form/manufacturer's Incident report (11/05/2012)  (523 ko)
Communication for placing into service IIa, IIb, III class medical devices and AIMDD - Explanatory note (07/05/2012)  (76 ko)
Manufacturer's Incident report form - Medical devices vigilance system (16/07/2010)  (717 ko)
Communication of IIa, IIb, III class medical devices and AIMDD - explanatory note (13/04/2010)  (62 ko)
Notice to manufacturers of radiotherapy medical devices (22/08/2007)  (106 ko)
   

Other topics

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Simultaneous determination of 34 weight-loss substances in slimming preparations by UHPLC with diode-array detection - Scientific poster (24/11/2016)  (303 ko)
Use of nir spectroscopy and raman chemical imaging to investigate the composition of anabolic tablets - Scientific poster (01/10/2014)  (291 ko)
Suspected adulterated food supplement: contributions of microbiology to bring out another potential risk for public health - Scientific poster (01/10/2014)  (664 ko)
Status of disinfectants used in the medical sector (Borderline with biocidal products PT2 and medical devices) (17/07/2014)  (43 ko)
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Request for research and study (open and directed) - Edition 2012 (12/03/2012)  (6846 ko)
Request for Projects 2012 - Standard evaluation grid (12/03/2012)  (357 ko)
Public declaration of interests (01/02/2012)  (459 ko)
Classification chart of the risks about conflicts of interests (01/02/2012)  (85 ko)
Aids to voluntary submission of genomics data (10/01/2012)  (54 ko)
Toxicological evaluation of nanoparticle medicinal products (V2-04/11) - Recommendations (01/12/2011)  (163 ko)
Clinical Trials - Voluntary Harmonisation Procedure for multinational clinical trials in Europe (VHP) (10/05/2010)  (323 ko)
HMA Initiatives on Clinical Trials - DIA Euroconference - March 9 2010 (10/03/2010)  (189 ko)
LEEM / IFIS meeting with AFSSAPS 29 June 2009 The short-, medium- and long-term roles of a national agency (16/07/2009)  (75 ko)
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Tissue and tissue products

French national proficiency testing study for the standardisation of the cfu-gm progenitor assay - Scientific poster (01/10/2014)  (222 ko)
Pilot study of endothelial cell density in tissue external quality control in Afssaps - EEBA 2010 (16/05/2011)  (701 ko)
Inspection of establishment storing tissues for end use “dépôt” (repository) (10/05/2011)  (475 ko)
Inspection of establishment storing tissues for end use “dépôt” (repository) (10/05/2011)  (475 ko)
Good Tissues and Cells Practices and EuroGTP (10/05/2011)  (282 ko)
Bacteriological and fungal contaminations of corneal organ cultures media in french eyes banks : 2008 results - EEBA 2010 (16/03/2010)  (225 ko)
External quality control of cornea organ culture media : 2007-2008 results - EEBA 2010 (16/03/2010)  (200 ko)
   

Vaccines

Recommendations regarding H1N1 vaccination of subjects involved or likely to be involved in clinical trials (04/12/2009)  (66 ko)
Vaccinations against Hepatitis B Virus: a summary of the discussions of the National Advisory Board of Pharmacovigilance of September 30th, 2008 (01/10/2008)  (117 ko)
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