Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-020"
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"en.20081022.2.3-020"2
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"Mr President, I wish to thank my colleague, Mrs Grossetête, for her excellent report. It is important to reform the laws on marketing authorisations because it will reduce the administrative burden that goes with processing them. At the same time, too, it will allow the use of resources to be steered towards issues that are essential for drug safety and public health, which is also in the interests of patients needing medication. After all, the main criterion is ultimately the interests of the patient.
I am in favour of a system where the same rules would apply both nationally and for authorisations granted in the context of EU processes. At present, the rules on the issue of market authorisations are harmonised regardless of the issuing process that is applied to them, but that has not been the case with the changes to the marketing authorisation. Accordingly, different Member States have been expecting partially different rules for such matters as the classification of the applications for amendments and in connection with the process for evaluating them. It is important for the pharmaceutical industry that it will still be able, in future, to submit a complete, new application for a market authorisation for a drug that already has one, but which has another commercial name and a different summary of product characteristics. This is necessary in situations where a marketing authorisation is being applied for in respect of medicinal products for a new purpose, and permitting a new name to be used is also clearer for the patient than using the same name when the drug is being used for very different purposes. I therefore support Amendments 4 and 18, which deal with this.
As pharmaceutical companies often supply the entire EU with medicinal products, it is important that the administrative processes in different countries are harmonised. Any other approach would mean not just a huge administrative burden for the industry, but often also logistical problems. I hope that Parliament will support Mrs Grossetête's report in tomorrow’s vote and that the Member States later on this year will also support Parliament’s views, so that the reform of the laws on marketing authorisations can be brought to a conclusion by the end of this year."@en1
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