Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-381-004"
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"en.20120911.32.2-381-004"2
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"I voted in favour of the proposal amending Regulation (EC) No 726/2004 as regards pharmacovigilance.
To ensure transparency in monitoring authorised medicines, the list of medicines subject to additional monitoring introduced by Regulation (EC) No 726/2004 should include all the medicines subject to safety conditions after authorisation. The European Medicines Agency, in collaboration with Member States, draws up, manages and publishes a list of medicines which are subject to additional monitoring. The list includes a link to the information about medicines and to the summary of the risk management plan. The relevant list includes the names and active ingredients of (a) the medicines authorised in the EU containing a new active ingredient which, on 1 January 2011, was not contained in any medicine authorised in the EU; (b) any biological medicine not covered by point (a) which was authorised after 1 January 2011; (c) medicines authorised pursuant to this regulation, subject to the conditions referred to in point (cb) of Article 9(4), point (a) of Article 10a(1) or Article 14(7) or (8); (d) medicines authorised pursuant to Directive 2001/83/EC, subject to the conditions referred to in points (b) and (c) of Article 21a, in Article 22, or in point (a) of Article 22a(1) of the relevant directive."@en1
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