European Parliament adopts report on drug packaging changes

3 November 2008

A report has been adopted by the European Parliament on a proposal by the European Commission to harmonize the regulatory system for changing marketing authorizations for drugs, to account for alterations to various items, such as packaging, manufacturer contact details, Patient Information Leaflets, etc. The reasoning behind the changes is that current European Union-level variations regulations do not prevent a national competent authority from issuing MA alterations, which can differ quite substantially.

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