Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-493"
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"en.20100921.18.2-493"2
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"Mr President, Marina Yannakoudakis, our shadow rapporteur, sends her apologies; she is unable to be in Strasbourg this week but she has asked me to pay particular credit to Linda McAvan for the very fruitful and cooperative way that she has worked with the other groups in drafting this legislation.
The aim of it is to strengthen the Community pharmacovigilance system of medicinal products for human use and we certainly believe that we have reached an agreement which will ensure, firstly, a more robust system of risk assessment, secondly, an improved system for marketing authorisations and post-authorisation safety and efficacy studies, thirdly, a better and more efficient means of reporting of any adverse drug reactions and fourthly, of course, greater transparency and medicinal safety.
Patients will also have better access, through web portals, to information regarding potential side effects of medicines, and these measures, we believe, will be of benefit, first and foremost, to European patients and citizens, but will also clarify and simplify the roles of the Commission, Member States, and risk assessment committees and pharmaceutical companies in ensuring the highest possible levels of patient safety throughout the EU."@en1
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