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Guidelines OCABR pour les médicaments biologiques humains

Plus d’informations sur la



Les Guidelines sur la libération des lots par les autorités officielles de contrôle de l’UE sont désormais exclusivement disponibles sur le site web de l'EDQM. La liste ci-après propose les versions les plus récentes.

Pour télécharger l’ensemble des procédures et guidelines, cliquez ici.

Le tableau suivant comporte les guidelines accessibles en téléchargement en cliquant sur le nom :

MÉDICAMENTS BIOLOGIQUES HUMAINS

Guidelines sur la libération des lots par les autorités officielles de contrôle de l’UE

Titre du document

Dernière mise à jour sur le site

Date d’entrée en vigueur

Guides utilisateurs   (retour en haut)    

Préface et Avis aux lecteurs 
 

 01/08/14  x
Explanatory Note on Correct Application of Section 3.2 of Product Specific Guidelines for Official Control Authority Batch Released 30/06/15 01/08/15

Procédures administrative OCABR (retour en haut)

 

EU Administrative Procedure for Official Control Authority Batch Release

 13/06/17

 01/07/17

Procedure for Official Control Authority Batch Release of Centrally Authorised Immunological Medicinal Products for Human Use and Medicinal Products Derived From Human Blood and Plasma

 01/08/14

 01/07/10

Médicaments dérivés de sang et de plasma humains – Guidelines-produits spécifiques (retour en haut)

 

Clotting Factor Concentrates, Plasma Inhibitor Concentrates and Fibrin Sealants

 19/05/16

 15/06/16

Human Albumin

 01/08/14

  01/01/12

Human Immunoglobulin

 17/08/16

  01/09/16

Human Plasma (pooled and treated for virus inactivation) formerly Solvent-Detergent (SD) Plasma

 25/11/14

  01/01/15

Protocol for Approval of Plasma Pools

 25/11/14

  01/01/15

Produits immunologiques constitués de vaccins - Guidelines-produits spécifiques (retour en haut)

 

BCG Vaccine

 01/08/14

  01/01/12

Cell Cultured Influenza Vaccine (Surface Antigen, Inactivated)

 01/08/14

  01/01/12

Cholera Vaccine (Oral, Inactivated)

 01/08/14

  01/01/12

Diphtheria and Tetanus Vaccine (adsorbed)

 01/08/14

  01/01/12

Diphtheria, Tetanus and Hepatitis B (rDNA) Combined Vaccine (adsorbed)

 01/08/14

  01/01/12

Diphtheria, Tetanus and Pertussis (Acellular Component) Combined Vaccine (adsorbed)

 12/12/14

  01/02/15

Diphtheria, Tetanus and Pertussis (Whole Cell) Combined Vaccine (adsorbed)

 01/08/14

  01/01/12

Diphtheria, Tetanus and Poliomyelitis (Inactivated) Combined Vaccine (adsorbed)

 01/08/14

  01/01/12

Diphtheria, Tetanus, Pertussis (Acellular Component) with separate Haemophilus Type B Conjugate Combined Vaccine (adsorbed)

 08/03/16

  01/04/16

Diphtheria, Tetanus, Pertussis (Acellular Component) and Hepatitis B (rDNA) Combined Vaccine (adsorbed)

 01/08/14

  01/01/13

Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Liquid Combined Vaccine 

 08/03/16   01/04/16

Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) with separate Haemophilus Type B Conjugate Combined Vaccine (adsorbed)

08/03/16

  01/04/16

Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) Combined Vaccine (adsorbed)

 01/08/14

  01/01/13

Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) and Haemophilus Type B Conjugate Combined Vaccine (adsorbed)

 12/07/16

  25/07/16

Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) with separate Haemophilus Type B Conjugate, Combined Vaccine (adsorbed)

 08/03/16

  01/04/16

Diphtheria, Tetanus, Pertussis (Whole Cell) and Poliomyelitis (Inactivated) Combined Vaccine (adsorbed)

 01/08/14

  01/01/12

Diphtheria, Tetanus, Pertussis (Whole Cell), Poliomyelitis (Inactivated) with separate Haemophilus Type B Conjugate Combined Vaccine (adsorbed)

 08/03/16

  01/04/16

Haemophilus Type B Conjugate and Meningococcal C Conjugate Combined Vaccine

 08/03/16

  01/04/16

Haemophilus Type B Conjugate Vaccine

 08/03/16

  01/04/16

Hepatitis A (Inactivated) and Hepatitis B(rDNA) Combined Vaccine (Adsorbed)

 01/08/14

  01/01/12

Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (adsorbed)

 08/03/16

  01/04/16

Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (Adsorbed) for Mix-At-Use Format Products

 08/03/16

  01/04/16

Hepatitis A Vaccine (Inactivated, Adsorbed)

 01/08/14

  01/01/12

Hepatitis A (Virosomal) Vaccine

 30/04/15

  01/06/15

Hepatitis B (rDNA) Vaccine

 01/08/14

  01/01/12

Human Papillomavirus (rDNA) Vaccine

 01/08/14

  01/01/12

Influenza Vaccine

 01/08/14

  01/05/13

Influenza Vaccine (Surface Antigen, Inactivated, Virosome)

 01/08/14

  01/01/12

Japanese Encephalitis Vaccine (Inactivated)

 01/08/14

  01/01/12

Live Attenuated Influenza Vaccine

 30/04/15

  01/06/15

Measles, Mumps, and/or Rubella Component Combined Vaccine

 01/08/14

  01/01/12

Measles, Mumps, Rubella and Varicella Combined Vaccine

 01/08/14

  01/01/12

Measles Vaccine

 01/08/14

  01/01/12

Meningococcal B Vaccine (Adsorbed)

 13/06/17

  15/07/17

Meningococcal Polysaccharide Vaccine

 08/03/16

  01/04/16

Monovalent or Multivalent Meningococcal Conjugate Vaccine, formerly under the title Meningococcal C Polysaccharide Protein Conjugate Vaccine

 08/03/16

  01/04/16

Multivalent Pneumococcal Polysaccharide Conjugate Vaccine

 08/03/16

  01/04/16

Mumps Vaccine

 01/08/14

  01/01/12

Pandemic Influenza Vaccine

 03/12/15

  01/01/16

Pertussis Vaccine (Acellular Component, Adsorbed)

 01/08/14

  01/01/13

Pneumococcal Polysaccharide Vaccine

 08/03/16

  01/04/16

Poliomyelitis Vaccine (Inactivated)

 01/08/14

  01/01/12

Poliomyelitis Vaccine (Oral) (OPV) – Monovalent Bulk

 21/02/17

  01/04/17

Poliomyelitis Vaccine (Oral) (OPV)

 21/02/17

  01/04/17

Rabies Vaccine

 01/08/14

  01/07/14

Rotavirus Vaccine

 01/08/14

  01/01/12

Rubella Vaccine

 01/08/14

  01/01/12

Tick-Borne Encephalitis (TBE) Vaccine

 01/08/14

  01/01/12

Typhoid Polysaccharide Vaccine

 08/03/16

  01/04/16

Typhoid Vaccine (Live -Strain Ty21a, Oral)

 01/08/14

  01/01/12

Vaccine Containing Vaccinia Virus Produced In Cell Culture (Smallpox Vaccine)

 12/12/14

  01/02/15

Varicella Vaccine and Shingles Vaccine

 01/08/14

  01/01/12

Yellow Fever Vaccine

 01/08/14

  01/01/13

Procédures connexes (retour en haut)

Administrative Procedure for European Official Medicines Control Laboratory Certification of Compliance of Batches under Article 58

 15/12/16

  01/02/17

Article 58 EU Official Control Authority Batch Compliance Testing of Hexaxim (Sanofi Pasteur)

 27/11/13

  obsolète

 

Article 58 EU Official Control Authority Batch Compliance Testing of Mosquirix (GSK), Malaria Vaccine 08/03/16 01/04/16

Informations générales (retour en haut)

Change Request for Revision of Adopted Guidelines/Procedures for Batch Release (OCABR-Human Network, VBRN)

 10/12/12

 x

 

NB. Tous les guidelines ont été mis à jour le 01/08/14 pour des raisons de modifications éditoriales sur la page de couverture. Le contenu n’a pas été change lors de cette mise à jour.

 

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