Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-021"
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"en.20081022.2.3-021"2
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"Creating harmonised criteria for the approval and administrative management of any kind of variations to marketing authorisations for medicinal products will benefit patients as they will have access to better and safer products in the long term.
Bearing in mind that only 20% of medicines for human and veterinary use are authorised via Community procedures, this revision of the directive will have a considerable impact on the pharmaceuticals market in the European Union. Any variations in the production process, changes to the packaging, or the manufacturer’s address, must be reviewed and simplified to ensure the best protection for public health. We need to create a simple, flexible legislative framework so that all medicinal products, whatever the procedure applied in authorising their marketing, are subject to the same evaluation and approval criteria.
This measure will ensure the free circulation of medicines in the European Union by abandoning the controls required to guarantee the quality of imported medicines and will help establish and make the internal market operate efficiently. This will speed up access to the latest medicines for consumers and the pharmaceutical industry, while also eliminating the discrepancies between national provisions and creating a harmonised system."@en1
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