Pharmaceutical Aspects of Product Information - EMEA publishes Concept Paper on a Guideline Revision

In 2002 the European Medicinces Agency (EMEA) Biotechnology Working Party drafted the first guidance on the product information (summaries of product characteristics, labelling and patient leaflets) for human vaccines. It was implemented in 2004 and since this time, it was not only an example to compile product information for human vaccines but also a standard-setting model for product information for a number of other classes of biological medicinal product.

The existing vaccines product information guideline remains valid. However, significant developments in both regulatory affairs and in vaccinology have taken place since its 2004 adoption which the guideline does not specifically address. So the following aspects should be discussed:

Regulatory affairs

  • All new and revised EMEA guidelines are now published in a standard format with Executive Summary, Introduction, Scope, Legal Basis, and Main Guideline Text as the major rubrics.
  • While the word ‘pharmaceutical’ is used in the title of the existing guideline, ‘quality’ is an equivalent word which is more commonly used in EMEA documents. The European Commission has introduced requirements for Braille markings in labels and leaflets.
  • In the case of certain vaccines with complex multi-component diluents, suitable short descriptions have been allowed to appear in section 6.1 of the SPC in place of full but impractically-long lists of all the diluent substances present.
  • For certain vaccines, means of expressing directions for non-refrigerated storage of the product have been approved.


  • New vaccine classes have been approved.
  • New combination vaccines have been approved.
  • There is potential for applications to be made to market live recombinant and virus vectored vaccines in the future. Already for such products, EMEA guidance has been drafted, clinical trials have been approved in certain

Now a consultation period of three months is proposed for this concept paper. In this time comments from external and internal stakeholders should be collected and evaluated for the revision uf the guideline.

More details can be found here.

The ECA Course GMP for Vaccine Manufacturers in Prague, Czech Republic, from 28-30 October 2009 provides insight into the GMP requirements of vaccine manufacturing. 

Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)



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