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Harmonization of requirements for influenza virus vaccines: the first year's experience with the EEC guideline
1Solvay Duphar b.v., Department of Regulatory Affairs, Weesp, The Netherlands.
Abstract:
An EEC guideline on the harmonization of requirements for influenza vaccines was published at the end of 1991. The document gives guidance on four different areas of harmonization. The 1992 production season was the first season during which this guideline was effective. The experience obtained as well as recommendations for further harmonization are discussed. After these important steps in the field of production and control of influenza vaccines, it is felt necessary to harmonize the use of influenza vaccines.