EMEA: Concept paper on a revision of the guideline on pharmaceutical aspects of the product information for human vaccines

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.