Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-033"
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"en.20081022.2.3-033"2
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"I welcome the report of Françoise Grossetête, which has the aim of simplifying and improving the system of regulatory conditions applying to changes to marketing authorisations for medicinal products. The original system for administering changes appears ineffective and unsatisfactory in view of new scientific knowledge and technological progress. The process for granting authorisation varies enormously at an intra-state level across the Member States of the European Union. There are variations in the procedures for reviewing medicinal products, in the time it takes to implement changes, and also in the requirements relating to the submission of documents.
I firmly believe that the harmonisation of these aspects will make a big contribution to the protection of public health. A more effective system will also have a positive impact on the pharmaceutical industry as a whole. I support the rapporteur in the improvements she has proposed. I agree with the view that all drugs, regardless of the procedure under which they were authorised for release onto the market, should be subject to the same assessment and approval criteria. A new improved regulatory system will deliver benefits for all patients, for the approval bodies and also for the pharmaceutical companies."@en1
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