Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-481"
| Predicate | Value (sorted: default) |
|---|---|
| rdf:type | |
| dcterms:Date | |
| dcterms:Is Part Of | |
| dcterms:Language | |
| lpv:document identification number |
"en.20100921.18.2-481"2
|
| lpv:hasSubsequent | |
| lpv:speaker | |
| lpv:translated text |
"Mr President, ladies and gentlemen, Commissioner Dalli is unable to attend this evening in order to address this issue in person and offers his apologies.
However, I have the pleasure of replacing him for the formal adoption of an agreement at first reading on the important subject of pharmacovigilance. May I take this opportunity to thank everyone who worked tirelessly in order to achieve this agreement, especially the rapporteurs, co-rapporteurs and shadow rapporteurs, especially Mrs McAvan, the rapporteur for the committee responsible. Thanks to the proposal which will be put to the vote in Parliament tomorrow, patients will be better protected against the adverse reactions of medicinal products.
In fact, the system of pharmacovigilance of medicinal products for human use in the European Union is to be strengthened and modernised. Not only will it offer better protection for public health; this system will also allow the internal market to function properly and current regulations and procedures to be rationalised. In addition, legislation will increase transparency and patient participation in the field of pharmacovigilance.
Finally, with the new scientific committee for pharmacovigilance created within the European Medicines Agency, the EMA will provide access to the most specialised scientific and medical expertise available for assessing the safety of medicinal products and recommending risk reduction measures.
The Commission is delighted that the institutions were able to arrive at a pre-negotiated common position before the summer recess and fully endorses the substance of the agreement reached. Within the framework of this agreement, the proposed amendment to restore the grade of director of the EMA has been deleted and the Commission is to publish the following statement:
‘Following the request made by the European Parliament and the Council on the grading of the head of the European Medicines Agency, the Commission, in order not to delay the adoption of this important proposal, undertakes to re-publish the vacancy notice for the next head of the European Medicines Agency with the grade AD15 instead of AD14.
The Commission considers that the right place to deal with the issue is the ongoing horizontal discussion on the role of EU agencies within the interinstitutional working group on agencies. The discussion on this aspect is open in the interinstitutional working group, and if this discussion leads to different conclusions at the appropriate publication level, then this grading could be reconsidered for future publications.’"@en1
|
| lpv:videoURI |
Named graphs describing this resource:
The resource appears as object in 2 triples