Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-043"
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"en.20081022.2.3-043"2
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"Although medicinal products from the European Community are constantly faced with regulations drawn up by national governments and the Community throughout their entire existence, discrepancies between the Commission’s regulations and the Member States’ provisions have negative repercussions from a public health and administrative perspective, as well as in terms of the general operation of the internal pharmaceuticals market.
The purpose of this report is to make sure that all medicinal products marketed in the Community, including those authorised at national level, are subject to the same administrative approval and amendment criteria, no matter which procedure was used to authorise these medicines. This proposal simplifies the administrative procedures for Member States and facilitates the harmonisation of evaluation and supervision requirements for all medicinal products.
Adopting this report will protect far more consumers who will benefit directly from improved efficiency, consolidated organisation, as well as clarity and transparency. This is the result of implementing a simplified, standardised regulation system supporting marketing authorisations for medicinal products in Europe."@en1
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