Friday, 1 March 2019

Updated Technical Guide for elaborating monographs on vaccines and sera for human use

At its 162nd session, the European Pharmacopoeia (Ph. Eur.) Commission approved a new edition of the Guide for the elaboration and use of monographs on vaccines and immunosera for human use (see the link below).

The Guide provides guidance to experts on the information to be included in Ph. Eur. monographs related to vaccines and sera for human use, and to harmonise the style of the different monographs.

The new edition of the Guide takes into account the experience gained in recent years in elaborating monographs in this field, and reflects recent developments in the Ph. Eur.

The Guide is primarily designed for Ph. Eur. experts drafting monographs on vaccines and sera, but it also provides useful information to help users better understand the requirements and structure of these monographs.

In particular, the document is intended to provide guidance to authors, contributors and users of European Pharmacopoeia (Ph. Eur.) on the elaboration of monographs for vaccines and other immunological human medicinal products (animal immunosera for human use). This applies in particular to: 

  • Group of Experts 15 (Vaccines and immunosera for human use);
  • Authorities responsible for granting marketing authorisations for vaccines and immunosera for human use; 
  • Official Medicines Control Laboratories (OMCLs); 
  • Manufacturers of vaccines and immunosera for human use; 
  • Bodies that procure vaccines and immunosera for health services; 
  • Public and private analytical laboratories working for one of the above; 
  • The Ph. Eur. Secretariat and other departments of the European Directorate for the Quality of Medicines & HealthCare (EDQM).
For details, see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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