EMEA: Concept paper on a revision of the guideline on pharmaceutical aspects of the product information for human vaccines
27.07.2009
In 2002 the Biotechnology Working Party at the EMEA began drafting guidance on the product
information (summaries of product characteristics, labelling and patient leaflets) for human vaccines.
The resulting guideline (‘Guideline o the Pharmaceutical Aspects of the Product Information for
Human Vaccines’) was adopted by the CPMP in 2003 and came into operation in June 2004. Since
that date, as well as serving to harmonise the product information for vaccines in Europe, the guideline
also incidentally acted as a model for standard-setting for the product information for a number of
other classes of biological medicinal product.
The source of the news: http://www.emea.europa.eu/pdfs/human/bwp/29068809en.pdf
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