Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-227"
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"en.20081022.17.3-227"2
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"This directive deals with regulations on marketing authorisations for medicinal products. We welcome the EU’s initiative to simplify and harmonise the current regulations. This is a time- and money-saving matter which will satisfy both manufacturers and consumers in Ireland.
The proposed revisions will be beneficial for the Irish pharmaceutical market which has a substantial presence in Europe. We are grateful that in this sector, 13 of the top 15 companies in the world currently operate in Ireland. There are currently over 140 med-tech companies in Ireland, which accommodate 26 000 jobs. Moreover, the annual export of medical devices amounts to approx EUR 6.2 billion, which is 10% of Ireland’s total exports.
We support the creation of single criteria for evaluation, approval and administration of pharmaceutical products that undergo changes such as manufacturing methods, product labelling or patient information brochures. We also recognise the need for further harmonisation of Member States’ national provisions and European regulations to reduce administrative burden and to simplify the system regulating changes, such as allowing a single application for one or more identical changes. We agree to the revision of the Commission’s control over ‘listings of substances’, ‘withdrawal periods’ and ‘principles and guidelines’."@en1
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