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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 :

MEDICAMENTS 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

 22/09/17

 x

Explanatory Note on Correct Application of Section 3.2 of Product Specific Guidelines for Official Control Authority Batch Release

30/06/15

01/08/15

Procédure administrative OCABR (retour en haut)

 

EU Administrative Procedure for Official Control Authority Batch Release

 16/01/19

 01/02/19

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)

 

Anthrax Vaccine (adsorbed) (NEW guideline)

28/02/19

01/04/19

BCG Vaccine

 06/03/18

  01/04/18

Cholera Vaccine (Oral, Inactivated)

 01/08/14

  01/01/12

Dengue Vaccine

 07/11/18

  01/12/18

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)

 27/03/18

15/04/18

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)

 27/03/18

15/04/18

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

 27/03/18

15/04/18

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

 27/03/18

15/04/18

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

 27/03/18

15/04/18

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

 27/03/18

15/04/18

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

 27/03/18

15/04/18

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

 27/03/18

15/04/18

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)

11/12/18

 01/01/19

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

11/12/18

  01/01/19

Hepatitis A Vaccine (Inactivated, Adsorbed)

11/12/18

  01/01/19

Hepatitis A (Virosomal) Vaccine

11/12/18

  01/01/19

Hepatitis B (rDNA) Vaccine

11/12/18

 01/01/19

Human Papillomavirus (rDNA) Vaccine

 11/12/18

 01/01/19

Influenza Vaccine

 01/08/14

  01/05/13

Influenza Vaccine (Surface Antigen, Inactivated, Virosome)

 11/12/18

  01/01/19

Influenza Vaccine (Surface Antigen, Inactivated) Produced in Cell Culture         

 18/03/19

  01/04/19

Japanese Encephalitis Vaccine (Inactivated)

 01/08/14

  01/01/12

Leptospirosis (Inactivated) Vaccine (NEW guideline)

17/06/19

 01/07/19

Live Attenuated Influenza Vaccine

 30/04/15

 01/06/15

Measles, Mumps, and/or Rubella Component Combined Vaccine

11/12/18

 01/01/19

Measles, Mumps, Rubella and Varicella Combined Vaccine

 11/12/18

  01/01/19

Measles Vaccine

 11/12/18

 01/01/19

Meningococcal B Vaccine (Adsorbed)

 13/06/17

  15/07/17

Meningococcal Polysaccharide Vaccine

 11/12/18

  01/01/19

Monovalent or Multivalent Meningococcal Conjugate Vaccine

 17/06/19

01/07/19

Multivalent Pneumococcal Polysaccharide Conjugate Vaccine

 08/03/16

  01/04/16

Mumps Vaccine

 11/12/18

  01/01/19

Pandemic Influenza Vaccine

 03/12/15

  01/01/16

Pertussis Vaccine (Acellular Component, Adsorbed)

 27/03/18

15/04/18

Pneumococcal Polysaccharide Vaccine

11/12/18

  01/01/19

Poliomyelitis Vaccine (Inactivated)

11/12/18

  01/01/19

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

 11/12/18

  01/01/19

Tick-Borne Encephalitis (TBE) Vaccine

 01/08/14

  01/01/12

Typhoid Polysaccharide Vaccine

 11/12/18

01/01/19

Typhoid Vaccine (Live -Strain Ty21a, Oral)

 01/08/14

  01/01/12

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

 11/12/18

 01/01/19

Varicella Vaccine and Shingles Vaccine

 11/12/18

 01/01/19

Varicella (rDNA) Vaccine

06/03/18

 01/04/18

Yellow Fever Vaccine

 11/12/18

 01/01/19

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)

 02/07/18

 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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