Brussels, 27/09/2010 (Agence Europe) - Last week the European Parliament (EP) adopted two reports by UK Labour MEP Linda McAvan on the revision of EU pharmacovigilance legislation. By the overwhelming majority of 559 votes for to 7 against, with 12 abstentions, the EP approved the amendments agreed with the Council. The text provides for the creation of medicines web portals at national and European levels to provide information on medicines and their proven side effects. National web portals, to be linked to an EU web portal, will include assessment reports, summaries of product characteristics and patient information leaflets. The portals and patient information brochures will also let patients know how to report any suspected adverse reactions, using national web portals or other means. Some medicines (for example, those containing a new active substance) will be authorised subject to additional monitoring after they have been placed on the market. These will be identified by a black symbol with the statement, “This medicinal product is subject to additional monitoring”, together with an explanatory sentence. A list of these products will be found on the European and national medicines web portals. The EU “Eudravigilance” database will be the single point for receipt of all pharmacovigilance information from marketing authorisation holders (companies) and national authorities. The database will be fully accessible to member states, the EU Medicines Agency and the Commission, and also accessible “to an appropriate extent” to marketing authorisation holders, healthcare professionals and the public. Personal data protection will be guaranteed. The new legislation will have to be applied 18 months after its publication in the Official Journal of the European Union. (O.J./transl.rt)