Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-512"
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"en.20100921.18.2-512"2
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"Mr President, ladies and gentlemen, I believe that the debate we have held today with the participation of so many MEPs demonstrates the importance of the agreement that has been reached between the EU institutions.
Amendments:
Directly acceptable: Amendment 74 (text as a whole, Block No 1, compromise amendment). The Commission is in favour of the adoption of the compromise text by the colegislators.
Proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (– C6-0515/2008 –)
Amendments:
Directly acceptable: Amendment 41 (text as a whole, Block No 1, compromise amendment). The Commission is in favour of the adoption of the compromise text by the colegislators.
The Commission, the Council and Parliament are sending out a strong signal to the citizens of our European Union, and this will also be reinforced by the fact files that will be approved – quickly, I hope – on counterfeit medicines and information to be given to patients. I also share the concerns expressed during the debate on the deaths caused by medicines that do not comply with the rules, as Mrs Ronzulli discussed. I also congratulate her for coming to the Chamber today with her baby daughter. This is a good sign: it means that young Europeans are growing up with a pro-European attitude.
I also agree with the words of Mr Dorfmann, and I believe it is only right for each one of us to be able to express ourselves in our own mother tongues and be able to understand what the standards guaranteeing our safety mean in our own languages, including in the world of medicines. I am a great supporter of multilingualism in all sectors, including the ones I am normally concerned with.
I would also like to reassure Mrs Vergnaud with regard to her concerns. I thank her on behalf of the entire European Commission, even though Commissioner Dalli was unfortunately unable to join us today; he will certainly be brought up to speed on this debate, and I will inform him of all the observations made by all the MEPs who took part in today’s meeting.
The Commission is sincerely grateful to you because, together, we have been able to send out a strong message to our fellow EU citizens.
As regards the issue raised by Mrs Rivasi on stronger rules on the environmental risks of medicinal products, we also consider that it is important to take account of the environmental protection aspect, and we accept Parliament’s suggestion that the Commission should present a report, where applicable, together with a legislative proposal on the environmental risks of medicinal products.
I should like to take this opportunity to remind the honourable Members that environmental aspects have already been included as an action point in the Commission communication on the future of the pharmaceutical sector, adopted prior to the present legislative proposal, within the framework of the pharmaceutical package presented in December 2008.
Annex – Position of the Commission
Proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (– C6-0514/2008 –)"@en1
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