Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-009"
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"en.20081022.2.3-009"2
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"−
Mr President, Commissioner, ladies and gentlemen, the report we are discussing today relates to some very important issues of harmonising the terms of marketing authorisations for medicinal products. As draftsman of the opinion of the European Parliament’s Committee on Agriculture, I would like to express my support for the Commission’s proposal. To date, only a small proportion of medicinal products falls within the remit of European legislation. Products that have received only national marketing authorisation are not subject to current European legislation on variations, and are therefore subject to various specific national laws. On the one hand, this is inefficient and costly to the economy while, on the other, it prevents the internal market from functioning smoothly.
Implementing the present directive would provide a legal basis for harmonisation and would bring great benefits to consumers and to the sector. It would also enable faster access to the latest medicinal products in all Member States. The lack of harmonised regulations means that each country applies its own specific national rules. This situation gives rise to red tape, barriers and difficulties in the operation of the internal market while resulting in differing safety criteria. Special attention should be paid to the cost to the Member States of implementing the new legislation. I do not believe that the countries of Europe will be able to amend their internal legislation within the short timescales provided to accommodate the additional changes, and which will entail high costs.
My congratulations to the rapporteur and I ask you to vote in favour of Mrs Grossetête’s report."@en1
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