Information in English

Information in English

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
   

ANSM

Afssaps - Annual report 2010 (20/10/2011)  (2330 ko)
   

Blood and blood products

2009 - Annual Haemovigilance report (12/04/2011)  (575 ko)
2009 - Annual Haemovigilance report - Abstract (12/04/2011)  (254 ko)
2008 - Annual Haemovigilance report (04/01/2010)  (437 ko)
French haemovigilance data on adverse reactions related to platelet transfusion (04/05/2009)  (618 ko)
Investigation of a suspicion of Transfusion Transmitted Bacterial Infection: The French experience (04/05/2009)  (792 ko)
"e-fit" the French Haemovigilance Data Base - Adverse Events associated with inappropriate transfusion of labile blood products but with any measurable biologic or clinical effect at the time of the observation - Report of Adverse Events of “grade 0” bet (07/06/2008)  (479 ko)
Incoherences or atypical values in the french basis of hemovigilance "unknown aetiologies" - ISBTS 2007 (12/05/2007)  (426 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)
Long - term national surveillance of coagulation factors supply in France - Congrès international sur l'Hémophilie- Bangkok (10/10/2004)  (134 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)
   

Cellular and gene therapy products

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

Risk assessment related to the use of aluminum in cosmetic products (17/11/2011)  (80 ko)
Cosmetovigilance: review of the adverse effects reported to Afssaps in 2007 (26/08/2008)  (851 ko)
   

Drugs

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)
Clarification concerning the good use of drugs in the event of a heat wave - Key messages (17/07/2009)  (41 ko)
Medicinal products and driving (02/07/2009)  (187 ko)
EU periodic safety update report synchronisation scheme and work sharing (29/04/2009)  (162 ko)
Risk management activity at Afssaps : Organisation, functioning, partnerships and developments (31/03/2009)  (199 ko)
8th EGA Regulatory Scientific Affairs Conference : Access to generic medicines through an efficient regulatory system (29/01/2009)  (70 ko)
Clarification on the conservation of drugs in the event of a heat wave (17/07/2008)  (73 ko)
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)
Medicinal products and Glucose-6-PhosphateDéshydrogénase (G6PD) Deficiency (25/02/2008)  (390 ko)
Misuse of drugs: the French hits (23/04/2005)  (41 ko)
How to choose a method of female contraception (02/12/2004)  (65 ko)
Medical follow up of patients with asthma -adults, adolescent (18/09/2004)  (119 ko)
Foetotoxicity of angiotensin II antagonists - Congrès ESH (23/06/2004)  (96 ko)
Chemical submission: study of case report - 66ème congrès du comité sur les problèmes de pharmacodépendance (23/06/2004)  (47 ko)
 

Forms- Administrative procedures

Good Manufacturing Practice Part II :basic requirement for Active substances used as starting material / Partie II des Bonnes Pratiques de Fabrication : exigences pour les MPUP (16/05/2012)  (502 ko)
Form for receipt of the fee following the performance of a requested inspection of starting materials for pharmaceutical use (16/05/2012)  (46 ko)
Specific request form for inspection concerning starting materials for pharmaceutical use (11/05/2012)  (45 ko)
Etat annuel d'établissement de fabrication, d’importation, d’exploitation ou de distribution des médicaments à usage humain et autres produits pharmaceutiques - Version bilingue (07/05/2012)  (12648 ko)
Notice to applicants for marketing authorisations for medicinal products for human use (23/12/2011)  (1031 ko)
Submission of Risk Minimisation Plans to Afssaps (15/02/2011)  (34 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)
Electronic exchanges of individual case safety reports (ICSRs) with Afssaps (30/06/2009)  (72 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)
Form to append to any correspondance or submission in the context of MA (13/05/2008)  (85 ko)
Déclaration d'exportation de médicament / export statement for medicinal products (13/05/2008)  (25 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)
Certificat de médicament OMS/Medicinal product certificate (13/05/2008)  (77 ko)
Notice to applicants for Temporary Authorisation for Use (ATU) (15/11/2007)  (735 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)
New European Active Substance Master File : Instructions and application form (13/02/2007)  (135 ko)
Response to a deficiency letter regarding an European Active Substance Master File : Instructions and application form (13/02/2007)  (122 ko)
Updating or variation of European Active Substance Master File : Instructions and application form (13/02/2007)  (135 ko)
Request for closing of European Active Substance Master File : Instructions and application form (13/02/2007)  (120 ko)
Change of European Active Substance Master File : Instructions and application form (13/02/2007)  (122 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" (26/01/2012)  (71 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)
Piratome sheet 4 - Ca-DTPA (26/01/2012)  (112 ko)
   

In vitro medical device

The installation and control in France of clinical trials relating to medical devices and in vitro diagnostic medical devices (21/05/2011)  (441 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)
Certificat de libre vente concernant les dispositifs médicaux de diagnostic in vitro/Free sale certificate for exportation of in vitro medical devices (01/12/2009)  (3922 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

Pilot phase relative to the declaration of serious adverse events occurring during biomedical research concerning a medical device (23/05/2012)  (30 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)
Important new information about a case of breast anaplastic large cell lymphoma in a woman who has had breast implants prefilled with silicone gel PIP (French company Poly Implants Prothèses) (06/12/2011)  (26 ko)
Topical Report on Injectable wrinkle fillers (30/06/2011)  (283 ko)
Topical report on PIP silicone gel-prefilled implants (29/06/2011)  (189 ko)
The installation and control in France of clinical trials relating to medical devices and in vitro diagnostic medical devices (21/05/2011)  (441 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)
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)
Antimicrobial Susceptibility Testing, a new item in the field of european standardisation (25/12/2004)  (453 ko)
 

Forms - Administrative procedures

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)
Certificat de libre vente concernant les dispositifs médicaux /Free sale certificate for exportation of medical devices (03/05/2012)  (1762 ko)
Application form for a consultation by a notified body on an ancillary medicinal substance integrated in a medical device/Formulaire de demande d'avis (15/10/2010)  (299 ko)
Summary of the characteristics of a device (MD or IVD) (01/09/2010)  (1215 ko)
Consultation on an ancillary medicinal substance integrated in a medical device : Documentation requirements /Structure du dossier à présenter (19/08/2010)  (347 ko)
Consultation on an ancillary medicinal substance integrated in a medical device : Notified body decision /Formulaire de décision de l'organisme notifié (19/08/2010)  (50 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)
Procedure to allow delivery of non Class III separated elements articular prosthesis to partial replacements (12/02/2010)  (194 ko)
Notice to manufacturers of radiotherapy medical devices (22/08/2007)  (106 ko)
   

Other topics

Clinical trials for medicines (not including cell treatment or gene therapy) Activity statement (24/04/2012)  (17 ko)
Clinical trials for not health products - Activity Statement (24/04/2012)  (47 ko)
The compassionate use of medicinal products : the French ATU system (27/03/2012)  (164 ko)
FAQ regarding the  Development Safety Update Report (DSUR)  (20/03/2012)  (118 ko)
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)
Interview with Jean Marimbert - Focus Reports (18/11/2009)  (198 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)
Afssaps Partnership with patients' and consumers' organisations Outcome of discussion and key recommendations -Summary report (16/05/2006)  (256 ko)
   

Tissue and tissue products

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)
Surveillance of biological products (Oct/06) (25/04/2008)  (181 ko)
Assessment of Advanced Therapy Biological Products (25/10/2006)  (466 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)