Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-366-750"
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"en.20120911.32.2-366-750"2
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"I voted in favour of this report because it is very important to ensure improved safety of medicines at EU level. We therefore have to strengthen the role of the European Medicines Agency (EMA) in collecting and immediately acting on signal detection and enhance cooperation between Member States. The additional amendments to the directive are needed to ensure that the Pharmacovigilance Risk Assessment Committee can manage its workload and to ensure that patients and health care professionals are fully involved in improving the pharmacovigilance system. Firstly, there must be a clear declaration on the withdrawal of a marketing licence or decision not to reapply for a licence. A list must be made public annually detailing the medicinal products for which marketing authorisations have been refused and the reasons for such action. Secondly, the marketing authorisation holder must also submit a notification if he or she has taken action in a third country because it would be useful for regulators to know if a company withdraws, does not renew or otherwise halts a marketing authorisation in a third country. Thirdly, a drug fact box should be created for the benefit of consumers so that they understand the usefulness of the drug as well as possible risks."@en1
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