In June 2006, the EMEA called for nominations from companies to participate in the pilot phase of a worksharing exercise for Quality variations1. Worksharing is a key element in the revisions to the variations proposed by the European Commission, which are intended to streamline the process for making changes to Marketing Authorisations, reducing the regulatory burden and encouraging innovation2. The worksharing procedure is intended where variations to the same nationally authorised product are submitted to the different National Competent Authorities (NCAs). All NCAs are eligible i.e. potentially all 29 EU/EEA states could be involved in the procedure.
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