Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-10-Speech-1-227-000"
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"en.20120910.29.1-227-000"2
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"Madam President, honourable Members, I am glad to be here for the formal endorsement of a first reading agreement on the important proposals on post-market control of medicines, the so-called pharmacovigilance. Pharmacovigilance makes a crucial contribution to public health and is key to the safety of patients.
May I take this opportunity to thank all those who worked very hard to make this agreement possible – in particular Ms McAvan, rapporteur for the lead committee, who has successfully facilitated the early conclusion of this dossier.
The stress test following the Mediator case identified certain gaps in our legislation. The proposal under consideration today will strengthen the transparency and reporting requirements of the 2010 package on pharmacovigilance. In particular, more categories of products will be subject to increased monitoring with a view to improving the reporting of adverse reactions to such medicines.
In addition, there will be greater transparency of the reasons for the withdrawal, interruption or non-renewal of the marketing of a product, as companies will have to declare the reasons for these. This will help to minimise the risk that a product falls through the net and thus escapes scrutiny when safety concerns are identified.
The confidence of patients in medicinal products is essential for therapeutic compliance; such confidence can only be achieved and maintained if patients trust our system. I am pleased that the proposal on which Parliament will vote tomorrow addresses the gaps identified in the existing pharmacovigilance legislation.
The Commission stands fully behind this agreement and is very pleased that it was concluded between the institutions before the summer break. As part of the agreement, with respect to the legislation on fees related to pharmacovigilance activities, the Commission makes the following statement:
On 18 June 2012, the Commission launched a public consultation on a concept paper concerning the introduction of fees for pharmacovigilance, as set out in Regulation (EU) No 1235/2010 and Directive 2010/84/EU, which is open for comments until 15 September 2012.
After examination of the comments received, the Commission will prepare an impact assessment which is one of the necessary steps in the legislative process before the Commission puts forward a legislative proposal. The Commission will continue to work on this file as a priority with the intention of presenting a legislative proposal as soon as possible to the European Parliament and the Council."@en1
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