Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-989"
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"en.20081022.17.3-989"2
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"(
Given the lack of harmonisation at Community level, variations to purely domestic marketing authorisations are subject to national legislation. In some Member States, the requirements relating to national marketing authorisations are analogous to those relating to variations in marketing authorisations. However, in the majority of countries, there is no such coordination, which means that legislative discrepancies exist between the Member States.
This situation has a negative impact in terms of public health, the administrative burden and the general operation of the internal market for pharmaceutical products.
All medicinal products, regardless of the marketing authorisation criteria, should be subject to the same evaluation criteria and to the same administrative measures when their marketing authorisation differs."@en1
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