Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-10-23-Speech-3-097"
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"en.20021023.2.3-097"2
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".
This proposal for a regulation is extremely important, because it is intended to ensure a high level of protection of human and animal health by means of more rigorous procedures for vigilance of the market and for pharmacovigilance, in order to increase the number of medicinal products available, to complete the internal market in pharmaceutical products and, lastly, to amend the aims and working methods of the European Agency for the Evaluation of Medicinal Products in the prospect of the enlargement of the EU. Where I disagree is neither on these great aims nor on every patient’s wish to have more rapid access, at Community level, to medicinal products containing new, safer and more effective active substances, but on certain specific details of the regulation, as demonstrated in the way I voted on this matter. In particular, with regard to the key issue of the extent to which the authorisation of medicinal products medicines should or should not be completely centralised in the EAEMP, I wish to state that I, like the majority established in the specialised parliamentary committee, am in favour of medicinal products for human use containing a new active substance being able to receive authorisation from the national agencies. I therefore oppose greater centralisation, which would be disastrous. In other words, I advocate the option of choosing between a centralised procedure and national authorisation, possibly accompanied by a procedure of mutual recognition."@en1
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