Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-037"

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"en.20081022.2.3-037"2
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"Mr President, ladies and gentlemen, thank you for the opportunity given to me to discuss the excellent work carried out by the rapporteur, Mrs Grossetête, and this proposal for a directive aimed at providing Community regulation applicable to all types of marketing authorisations for medicinal products. This is a positive directive, welcomed for its objectives of protecting public health and cutting red tape. The proposal for a directive is of a legal nature, introducing simple amendments to the legal basis behind the rules on variations, such as the introduction of a new therapeutic indication or a new method of administration, made to medicinal products for human or veterinary use after they are first placed on the market. Harmonisation in this area has become necessary, if not crucial, because without a single Community legal framework, variations concerning national authorisations will continue to be subject to national laws that differ from one Member State to another, as is the case at present."@en1
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