MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'MPA RSS news -' source. Wed, 08 Feb 2012 19:15:02 +0100 http://www.medworm.com/index.php?rid=5649891&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FEmptyPage.aspx%3Fid%3D12809%26epslanguage%3Den (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=5649891 Thu, 02 Feb 2012 05:00:00 +0100 5649891 http://www.medworm.com/index.php?rid=5649890&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D12810%26epslanguage%3Den The Medical Products Agency (MPA) has previously presented results from studies performed in Sweden on the safety of the pandemic vaccine Pandemrix. To further elucidate an association between narcolepsy and vaccination the MPA has initiated further research. The studies are coordinated by the MPA and are conducted both by in-house and by independent researchers and are expected to be ongoing during 2012. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=5649890 Thu, 02 Feb 2012 05:00:00 +0100 5649890 http://www.medworm.com/index.php?rid=5287198&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D11794%26epslanguage%3Den The MistraPharma research program has been granted 5,7 million Euro (SEK 52 millions) for continued research into the environmental impact of pharmaceuticals by the The Swedish Foundation for Strategic Environmental Research (Mistra). MistraPharma is supported by the Swedish Medical Products Agency. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=5287198 Wed, 05 Oct 2011 12:55:00 +0100 5287198 http://www.medworm.com/index.php?rid=4994535&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D11544%26epslanguage%3Den The Swedish Medical Products Agency (MPA) has published a report on how environmental standards in pharmaceutical production can be sharpened within the EU. The proposal is unique and forces all manufacturers to follow the GMP rules on pharmaceuticals sold on the EU markets. In recent years, manufacturing of pharmaceuticals in low cost countries like India and China has drawn attention because of the environmental impact. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4994535 Mon, 04 Jul 2011 13:02:00 +0100 4994535 http://www.medworm.com/index.php?rid=4994536&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D11541%26epslanguage%3Den The Medical Products Agency has signed a cooperation agreement with its Brazilian counterpart ANVISA. The aim of the agreement is to increase the exchange of information and experience within the areas of the improved use of medical products, sustainable development, resistance to antibiotics, medical technology, electronic submissions and pharmacopoeia and pharmacovigilance activities. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4994536 Mon, 04 Jul 2011 08:30:00 +0100 4994536 http://www.medworm.com/index.php?rid=4987440&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D11514%26epslanguage%3Den The Medical Products Agency in Sweden has conducted a Case Inventory Study which provides strengthened evidence for an association between vaccination with Pandemrix and narcolepsy in children and adolescents, 19 years and younger. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4987440 Thu, 30 Jun 2011 09:00:00 +0100 4987440 http://www.medworm.com/index.php?rid=4678365&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D11213%26epslanguage%3Den The Swedish Medical Products Agency participates actively in the decentralised procedure (DCP) as reference member state (RMS) and has since the start received a high number of requests for time slots. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4678365 Tue, 05 Apr 2011 15:21:00 +0100 4678365 http://www.medworm.com/index.php?rid=4646070&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D11153%26epslanguage%3Den Results from a Swedish registry based cohort study indicate a 4-fold increased risk of narcolepsy in children and adolescents below the age of 20 vaccinated with Pandemrix, compared to children of the same age that were not vaccinated. The results are in line with those of a similar Finish registry study. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4646070 Tue, 29 Mar 2011 09:30:00 +0100 4646070 http://www.medworm.com/index.php?rid=4357181&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D10934%26epslanguage%3Den Worksharing does not apply to variations for purely nationally authorised products until the variation regulation (EC) 1234/2008 has been updated with information regarding nationally authorised products. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4357181 Mon, 17 Jan 2011 16:32:00 +0100 4357181 http://www.medworm.com/index.php?rid=4357182&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FEmptyPage.aspx%3Fid%3D10933%26epslanguage%3Den (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4357182 Mon, 17 Jan 2011 16:31:00 +0100 4357182 http://www.medworm.com/index.php?rid=4276409&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D10868%26epslanguage%3Den The outcome of the evaluation of the pilot project of joint scientific advice was very positive. Therefore, the collaboration between the TLV and MPA will continue. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4276409 Tue, 21 Dec 2010 14:13:00 +0100 4276409 http://www.medworm.com/index.php?rid=4028766&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D10559%26epslanguage%3Den The pilot project of joint scientific advice meetings arranged by the Dental and Pharmaceutical Benefits Agency (TLV) and the Medical Products Agency (MPA), ended June 30th 2010. The project will be evaluated by the MPA, the TLV and the companies involved during autumn 2010. It is still possible to apply for joint scientific advice until a conclusion has been reached and published regarding the continuation of the project. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4028766 Sun, 03 Oct 2010 23:00:00 +0100 4028766 http://www.medworm.com/index.php?rid=4276410&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D10480%26epslanguage%3Den The MPA has during the past year undergone a thorough survey of processes followed by a reorganisation. The new organisation; with partly new units and areas, will be in operation from September 1, 2010. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4276410 Mon, 13 Sep 2010 09:13:00 +0100 4276410 http://www.medworm.com/index.php?rid=3956071&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D10473%26epslanguage%3Den The investigation of a possible relationship between Pandemrix and reported cases of narcolepsy is currently ongoing in Sweden and several other EU-countries. So far 22 cases have been reported by the Swedish health care system and MPA is currently trying to assess back ground incidence of narcolepsy. Together with this update the MPA also provides a document describing how the overall investigation is being performed. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3956071 Thu, 09 Sep 2010 23:00:00 +0100 3956071 http://www.medworm.com/index.php?rid=3930996&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D10439%26epslanguage%3Den From 1 October, the MPA will accept variation applications for nationally authorised products only if they are submitted according to the new variation regulation (EC) No 1234/2008. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3930996 Thu, 02 Sep 2010 23:00:00 +0100 3930996 http://www.medworm.com/index.php?rid=3905433&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D10400%26epslanguage%3Den In total, there are 12 cases of narcolepsy reported to the MPA from healthcare professionals in Sweden with a suspected relationship to vaccination with Pandemrix. In addition to the cases reported in Sweden and Finland there are a few further cases reported in France, Germany and Norway. An investigation is ongoing, but any relationship between the vaccination and the reported symptoms can not be concluded. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3905433 Wed, 25 Aug 2010 23:00:00 +0100 3905433 http://www.medworm.com/index.php?rid=3878730&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D10368%26epslanguage%3Den The MPA has received six reports from health care professionals regarding narcolepsy as suspected adverse drug reaction following Pandemrix flu vaccination. The Agency will, in consultation with external experts, assess the possible relationship between the vaccination and the reported reactions. The MPA is in contact with other EU member states to get information if there are any reports in other countries. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3878730 Tue, 17 Aug 2010 23:00:00 +0100 3878730 http://www.medworm.com/index.php?rid=4276411&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D10238%26epslanguage%3Den The MPA is currently undergoing a reorganisation and many employees are going to change rooms within our premises. We kindly ask for your indulgence for any interference that might occur. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4276411 Mon, 28 Jun 2010 14:06:00 +0100 4276411 http://www.medworm.com/index.php?rid=3619525&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D10137%26epslanguage%3Den As of April 16, 2010 about 6.1 million adult doses of Pandemrix have been administered according to preliminary data from the county councils to the Swedish Institute for Infectious Disease Control (SMI). The Medical Products Agency (MPA) has received a total of 4380 adverse events reports (ADR) from Health Care Professionals and from consumers during the pandemic period. In view of the great number of vaccinated individuals in Sweden and the limited number of adverse drug reaction reports and their pattern, the conclusion is that the safety of the vaccine is satisfactory. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3619525 Tue, 01 Jun 2010 23:00:00 +0100 3619525 http://www.medworm.com/index.php?rid=3371957&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9818%26epslanguage%3Den On the 15th of March, 2010, new routines for handling recalls will be introduced in Sweden for all products regulated by the legislation (Medicinal Products Act (SFS 1992:859) of the medicinal products: conventional medicinal products, herbal medicinal products, traditional herbal medicinal products, natural remedies, certain medicinal products for external use, homeopathic medicinal products and standardised extemporaneous preparations (stock manufacturing). (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3371957 Wed, 17 Mar 2010 00:00:00 +0100 3371957 http://www.medworm.com/index.php?rid=4276412&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9752%26epslanguage%3Den The webpage on variations has been extensively updated with new information regarding the handling of variations in accordance with the new variation regulation. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4276412 Fri, 26 Feb 2010 10:43:00 +0100 4276412 http://www.medworm.com/index.php?rid=3225964&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9665%26epslanguage%3Den During 2010, Medical Products Agency will be in head of a collaborative effort to improve the dissemination of knowledge about medicinal effects in clinical everyday life in Europe. The MPA will support networks within the EU as a successful working in the field of "drug effectiveness". (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3225964 Mon, 01 Feb 2010 00:00:00 +0100 3225964 http://www.medworm.com/index.php?rid=3181021&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9593%26epslanguage%3Den About 5.3 million individuals in Sweden, corresponding to 60% of the Swedish population, have been vaccinated with Pandemrix as of January 8. In total, the Medical Products Agency has received about 3700 adverse event reports from Health Care Professionals and from consumers. In view of the great number of vaccinated individuals in Sweden and the limited number of adverse drug reaction reports and their pattern, the conclusion is that the safety of the vaccine in use is satisfactory. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3181021 Mon, 18 Jan 2010 00:00:00 +0100 3181021 http://www.medworm.com/index.php?rid=4276413&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FEmptyPage.aspx%3Fid%3D9559%26epslanguage%3Den (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4276413 Tue, 05 Jan 2010 09:17:00 +0100 4276413 http://www.medworm.com/index.php?rid=3140351&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9560%26epslanguage%3Den The Medical Products Agency (MPA) has decided - in agreement with the European Medicines Agency (EMA) - to simplify the electronic handling of adverse reaction reporting. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3140351 Tue, 05 Jan 2010 00:00:00 +0100 3140351 http://www.medworm.com/index.php?rid=4276414&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9494%26epslanguage%3Den A guideline to the Medical Products Agency´s regulation (2005:11) on labelling and package leaflets for medicinal products is now published on the website. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4276414 Thu, 17 Dec 2009 16:50:00 +0100 4276414 http://www.medworm.com/index.php?rid=3094356&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9483%26epslanguage%3Den Medical Products Agency (MPA) has been commissioned by the Swedish Government to identify opportunities for strengthening the environmental requirements pertaining to the manufacturing of medicinal products with greatest emphasis on EU and international efforts rather than national work. The report suggests, among other, requirement for an environmental certification of the production facilities to be introduced to the legislation on good manufacturing practice (GMP). (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3094356 Thu, 17 Dec 2009 00:00:00 +0100 3094356 http://www.medworm.com/index.php?rid=4276415&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9473%26epslanguage%3Den The new variation regulation (EC) No 1234/2008 applies from 1 January 2010 for medicinal products approved via the mutual recognition procedure (MRP), decentralized procedure (DCP) and the Centralised procedure. The new variation regulation replaces the former regulations: (EC) No 1084/2003 (MRP/DCP) and (EC) No 1085/2003 (centralised marketing authorisations). (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=4276415 Wed, 16 Dec 2009 13:29:00 +0100 4276415 http://www.medworm.com/index.php?rid=3083661&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9467%26epslanguage%3Den Almost 4 million individuals in Sweden have been vaccinated as of December 4. In total, the Medical Products Agency has received close to 3000 adverse event reports from Health Care Professionals and from consumers. The reporting pattern is generally consistent with what has been seen from previous clinical trials, with the exception of allergic and neurological reactions. In view of the great number of vaccinated individuals in Sweden and the limited number of adverse drug reaction reports and their pattern, the conclusion is that the safety of the vaccine in use is satisfactory. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3083661 Mon, 14 Dec 2009 00:00:00 +0100 3083661 http://www.medworm.com/index.php?rid=3046405&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9428%26epslanguage%3Den The pilot project of joint scientific advice meetings arranged by the TLV and the MPA is extended to June 30th 2010. The last date for a meeting with the TLV and the MPA is therefore June 30th 2010. Applications for a meeting in May or June should be submitted to the MPA at least 2 months before. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3046405 Wed, 02 Dec 2009 00:00:00 +0100 3046405 http://www.medworm.com/index.php?rid=3032225&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9411%26epslanguage%3Den Almost 3.4 million adult doses of Pandemrix have been delivered to Sweden as of November 17. According to data from the Swedish Institute for Infectious Disease Control (SMI), by November 15 approximately 1.9 million individuals in Sweden have been vaccinated. In total, the Medical Products Agency has received close to 1000 adverse event reports from Health Care Professionals and about 1300 reports from consumers. The reporting pattern is generally consistent with what has been seen from previous clinical trials, with the exception of allergic reactions. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=3032225 Thu, 26 Nov 2009 00:00:00 +0100 3032225 http://www.medworm.com/index.php?rid=2994570&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9375%26epslanguage%3Den On 10-11 November the Medical Products Agency hosted a European Conference on “Sustainable Development and Pharmaceuticals”. EU environmental and health authorities, the Commission, Parliament, the European Medicines Agency EMEA, industry and academia attended the meeting which took place in Uppsala. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2994570 Mon, 16 Nov 2009 00:00:00 +0100 2994570 http://www.medworm.com/index.php?rid=2986971&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9372%26epslanguage%3Den As of today, about 2.1 million doses of Pandemrix have been distributed in Sweden. In total, almost six hundred adverse drug reaction (ADR) reports have been received by the MPA from Health Care Professionals and close to 900 reports from Consumers. The ADR reporting pattern is generally consistent with the expected pattern seen previously in the clinical trials. In this compilation of ADRs reported in Sweden with Pandemrix, allergic reactions, neurological reactions and reactions in children are specifically addressed. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2986971 Thu, 12 Nov 2009 00:00:00 +0100 2986971 http://www.medworm.com/index.php?rid=2941424&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9326%26epslanguage%3Den As of today, about 1.4 million doses of Pandemrix have been distributed in Sweden. In total, about two hundred adverse drug reaction (ADR) reports have been received by the MPA from Health Care Professionals and between 400-500 reports from consumers. The ADR reporting pattern does not deviate from what has been seen in the clinical trials. However, there is particular reason to follow reports of allergic reactions. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2941424 Thu, 29 Oct 2009 00:00:00 +0100 2941424 http://www.medworm.com/index.php?rid=2582240&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D9005%26epslanguage%3Den Early in the Swedish presidency of the EU, the 24th meeting of Competent Authorities for Medical Devices took place in Uppsala on 2-3 July 2009. Participants from EU member states and European Commission representatives discussed a number of important issues on the future of regulating medical devices. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2582240 Mon, 06 Jul 2009 23:00:00 +0100 2582240 http://www.medworm.com/index.php?rid=2565522&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D8966%26epslanguage%3Den The list at Heads of Medicines Agencies is now updated with the latest information and additional specification. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2565522 Thu, 02 Jul 2009 23:00:00 +0100 2565522 http://www.medworm.com/index.php?rid=2518906&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D8814%26epslanguage%3Den Correctly functioning Information Technology (IT) systems for health care is a prerequisite for ensuring patient safety. However, applicable regulation is rarely applied, mainly due to the lack of useful guidelines on how to classify the IT-systems. A national working group in Sweden has prepared a guidance report that will help increase compliance with the Medical Device regulation in the EU, thus improving patient safety. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2518906 Wed, 17 Jun 2009 23:00:00 +0100 2518906 http://www.medworm.com/index.php?rid=2460670&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D8775%26epslanguage%3Den Collaboration between the Dental and Pharmaceutical Benefits Agency (TLV) and the Medical Products Agency (MPA) offers new opportunity for joint scientific advice meetings. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2460670 Thu, 04 Jun 2009 04:00:00 +0100 2460670 http://www.medworm.com/index.php?rid=2310105&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D8517%26epslanguage%3Den From 1 April 2009, the MPA accepts electronic-only for submissions for human medicinal products within the National Procedure, the Mutual Recognition Procedure and the Decentralised Procedure. The MPA already accepts electronic-only submissions within the Centralised Procedure. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2310105 Wed, 01 Apr 2009 04:00:00 +0100 2310105 http://www.medworm.com/index.php?rid=2289324&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D8338%26epslanguage%3Den Herb-based dietary supplement contained active drug substance. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2289324 Wed, 25 Feb 2009 05:00:00 +0100 2289324 http://www.medworm.com/index.php?rid=1996267&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____7951.aspx Singapore’s Health Sciences Authority (HSA) and its Swedish regulatory counterpart, the Medical Products Agency (MPA) have signed a Memorandum of Understanding (MOU) in the regulation of health products. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=1996267 Fri, 28 Nov 2008 05:00:00 +0100 1996267 http://www.medworm.com/index.php?rid=1837139&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____7707.aspx Some batches of Klexane are placed into quarantine. This is a precautionary measure while the MPA awaits the result of an audit of the full supply-chain in China. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=1837139 Mon, 29 Sep 2008 04:00:00 +0100 1837139 http://www.medworm.com/index.php?rid=1406945&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____7312.aspx On 23 April 2008, the Medical Products Agency decided to recall the contaminated batches of Klexane found on the Swedish market. The level of contamination is low and the recall was made as a precautionary measure. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=1406945 Tue, 29 Apr 2008 04:00:00 +0100 1406945 http://www.medworm.com/index.php?rid=1265122&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____7057.aspx The Medical Products Agency (MPA) has received a high number of requests to act as Reference Member State for the Decentralised Procedure over the last years. As a result of this the MPA is fully booked for 2008 and the first 6 months of 2009. Read more about what you should do as an applicant. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=1265122 Thu, 28 Feb 2008 05:00:00 +0100 1265122 http://www.medworm.com/index.php?rid=2518911&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D7040%26epslanguage%3Den The Medical Products Agency has now concluded its review of the dental implants NobelDirect and NobelPerfect. The company, Nobel Biocare has improved the instructions for use for the implants and therefore these can be sold again without restraints. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2518911 Tue, 26 Feb 2008 00:00:00 +0100 2518911 http://www.medworm.com/index.php?rid=1015743&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____6685.aspx The main object of the new EU paediatric regulation starting 26th of January 2007 is to improve the health of children by better regulation of medicines used for children. All available results of paediatric studies and trials should be submitted by marketing authorisation holders to the national competent authorities or to the EMEA before 26 January 2008. Further paediatric studies should be submitted on an ongoing basis within six months of their completion. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=1015743 Fri, 09 Nov 2007 05:00:00 +0100 1015743 http://www.medworm.com/index.php?rid=1013330&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____6670.aspx All spontaneous reports and reports from non-interventional studies with events that occurred in Sweden should be reported directly to the EMEA (EudraVigilance database) before January 1st, 2008, if not previously reported electronically to the MPA. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=1013330 Thu, 08 Nov 2007 05:00:00 +0100 1013330 http://www.medworm.com/index.php?rid=980510&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____6620.aspx The Medical Products Agency (MPA) and the National Food Administration (NFA) have jointly carried out a study concerning the contents of a number of slimming preparations and similar products, purchased at the Internet with the principal aim to control the contents of substances with well known safety problems. The analyses were carried out at the MPA’s laboratory. The selection of products included in this study does not claim to be complete. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=980510 Fri, 26 Oct 2007 04:00:00 +0100 980510 http://www.medworm.com/index.php?rid=972715&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____6600.aspx By 2010 the Swedish Medical Products Agency will have introduced a new working method, using automated case management and information management in electronic form instead of the current paper-based system. “The new working method gives the agency the opportunity to concentrate more on its core activity,” says Director-General Gunnar Alvan. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=972715 Tue, 23 Oct 2007 04:00:00 +0100 972715 http://www.medworm.com/index.php?rid=933972&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____6532.aspx On Friday October 5th, Dr. Tomas Salmonson from the Swedish Medical Products Agency was appointed by the European Commission to represent the EU at the ICH Steering Committee. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=933972 Mon, 08 Oct 2007 04:00:00 +0100 933972 http://www.medworm.com/index.php?rid=870360&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____6438.aspx Lena Björk, has been appointed new director at the Medical Products Agency, with responsibility for assessment and regulatory units. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=870360 Thu, 06 Sep 2007 04:00:00 +0100 870360 http://www.medworm.com/index.php?rid=870361&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____6432.aspx Nobel Biocare has completed the plan for improving the information about the dental implants NobelDirect and NobelPerfect. The company has complied with the main points required by the Medical Products Agency. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=870361 Mon, 03 Sep 2007 04:00:00 +0100 870361 http://www.medworm.com/index.php?rid=776096&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____6356.aspx Marketing authorisation holders (MAH) are required to inform the Medical Products Agency if their approved medicinal products are available on the Swedish market or not. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=776096 Thu, 12 Jul 2007 04:00:00 +0100 776096 http://www.medworm.com/index.php?rid=2518920&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D6312%26epslanguage%3Den Starting August 1st, the Medical Products Agency will begin to evaluate its routine for Scientific Advice to the industry. Companies will be given an opportunity to provide feed-back on the service provided. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2518920 Wed, 27 Jun 2007 23:00:00 +0100 2518920 http://www.medworm.com/index.php?rid=2518921&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage.aspx%3Fid%3D6286%26epslanguage%3Den The Medical Products Agency has now reviewed Nobel Biocare’s plan to improve the information on the dental implants NobelDirect and NobelPerfect. The Medical Products Agency’s assessment is that the instructions for use require more information in addition to the measures that the company has suggested. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=2518921 Sun, 24 Jun 2007 23:00:00 +0100 2518921 http://www.medworm.com/index.php?rid=566746&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____6044.aspx Since November 2006, generic applications where the generic has more or fewer indications than the reference product in the CMS are accepted. The applicant must inform the RMS of the differences between Member States. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566746 Wed, 18 Apr 2007 04:00:00 +0100 566746 http://www.medworm.com/index.php?rid=566747&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____5869.aspx Manufacturers report adverse reactions to the Medical Products Agency... At 10 a. m. on Friday 2rd March 2007 the ingoing channel to the Medical Products Agency... The computer problems were dealt with on Monday the 5th of March. During the stop many MAH have had their reports ’rejected’ because of ’Max... (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566747 Mon, 05 Mar 2007 05:00:00 +0100 566747 http://www.medworm.com/index.php?rid=566748&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____5788.aspx The Medical Projects Agency has reviewed Nobel Biocare’s plan for taking measures to improve their instructions for use for the NobelDirect and NobelPerfect dental implants. The Medical Projects Agency now requests additional information from Nobel Biocare AB. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566748 Thu, 15 Feb 2007 05:00:00 +0100 566748 http://www.medworm.com/index.php?rid=566749&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____5774.aspx The Medical Products Agency, the National Board of Health and Welfare and the Swedish Society of Cardiology call for utmost restraint in the use of drug-eluting stents. These should only be used in such rare cases where there is no alternative treatment. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566749 Wed, 14 Feb 2007 05:00:00 +0100 566749 http://www.medworm.com/index.php?rid=566750&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____5510.aspx The Swedish Medical Products Agency investigation of the dental implants NobelDirect and NobelPerfect show that there can be deficiencies in the instructions for use for the products. The Medical Products Agency has ordered the company Nobel Biocare to clarify certain information in the information materials for the products. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566750 Wed, 06 Dec 2006 05:00:00 +0100 566750 http://www.medworm.com/index.php?rid=566751&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____5421.aspx Applications for marketing authorisations should be in compliance with current... This also applies for so called multiple applications or duplicates. Application form and practical guidance are now available on the website. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566751 Wed, 01 Nov 2006 05:00:00 +0100 566751 http://www.medworm.com/index.php?rid=566752&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____5373.aspx The Swedish Medical Products Agency is investigating the dental implant Nobel... Nobel Biocare has announced that they, during the first week of November... The Medical Products Agency has today decided to consider the data presented... (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566752 Wed, 25 Oct 2006 04:00:00 +0100 566752 http://www.medworm.com/index.php?rid=566753&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____5265.aspx Within the scope of the Swedish Medical Products Agency’s investigation of the... The meeting was held on request from Nobel Biocare and gave the company the... When the Medical Products Agency decides on the safety of the dental implant... The Medical Products Agency intends to make a decision on the dental implant... (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566753 Tue, 10 Oct 2006 04:00:00 +0100 566753 http://www.medworm.com/index.php?rid=566754&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____4702.aspx Under the LVFS 2006:10 regulation, veterinary surgeons who normally work in other European Economic Area (EEA) member states (EU countries plus Norway, Iceland and Liechtenstein) will be entitled to import limited quantities of pharmaceuticals for their professional operations in Sweden. A veterinary surgeon who normally works in Sweden will also be entitled to bring back unused pharmaceuticals to Sweden after serving in another EEA country. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566754 Thu, 22 Jun 2006 04:00:00 +0100 566754 http://www.medworm.com/index.php?rid=566755&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____4533.aspx The European Commission have published the guideline on definition of potential... The guidelines were published in the Official Journal 8 June. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566755 Tue, 13 Jun 2006 04:00:00 +0100 566755 http://www.medworm.com/index.php?rid=566756&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____4452.aspx From the 1st of June Christina Wik is appointed head of the Regulatory Administration Department at Medical Product Agency, Sweden. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566756 Mon, 29 May 2006 04:00:00 +0100 566756 http://www.medworm.com/index.php?rid=566757&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____4393.aspx The Medical Product Agency (MPA) introduces a new application form concerning... This form should be used for nationally approved products. A similar form is available for Mutual recognition procedure (MRP) and... (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566757 Thu, 11 May 2006 04:00:00 +0100 566757 http://www.medworm.com/index.php?rid=566758&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____4352.aspx The Food and Drug Administration (FDA) and the Medical Products Agency (MPA) of Sweden have signed a mutual Confidentiality Arrangement effective as of April 2006. The Arrangement allows the two Agencies to share certain non-public information, including law enforcement information and internal pre-decisional information. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566758 Fri, 28 Apr 2006 04:00:00 +0100 566758 http://www.medworm.com/index.php?rid=566759&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____4268.aspx The Parliament has adopted the proposal from the government to revise the... The implementation will come into force 1 May 2006. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566759 Fri, 07 Apr 2006 04:00:00 +0100 566759 http://www.medworm.com/index.php?rid=566765&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____4075.aspx The Medical Products Agency's provisions on the packaging and the labelling of medicinal products was decided 19 October 2005 and went into force 1 December 2005. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566765 Mon, 27 Mar 2006 05:00:00 +0100 566765 http://www.medworm.com/index.php?rid=566764&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____4076.aspx The process of transposing the legislation from directives to the national law is nearly ended. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566764 Mon, 27 Mar 2006 05:00:00 +0100 566764 http://www.medworm.com/index.php?rid=566763&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____3230.aspx Effective from November 11, 2005, the MPA will issue Letters of Approval together with relevant attachments when a new product, a change of a Marketing Authorisation affecting indication or dosage, or a change of legal status is approved. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566763 Mon, 13 Mar 2006 05:00:00 +0100 566763 http://www.medworm.com/index.php?rid=566762&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____3229.aspx The new pharmaceutical legislation will according to the current proposal be implemented in Swedish laws and regulations by 1 April 2006. This will for instance mean that an authorisation normally will be valid for an unlimited period. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566762 Mon, 13 Mar 2006 05:00:00 +0100 566762 http://www.medworm.com/index.php?rid=566761&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____3228.aspx Yesterday, participants from Medical Products Agency, Nobel Biocare and clinicians met for a discussion regarding the amount of bone resorption for the Nobel Direct dental implant. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566761 Mon, 13 Mar 2006 05:00:00 +0100 566761 http://www.medworm.com/index.php?rid=566760&cid=s_35520_23_f&fid=35520&url=http%3A%2F%2Fwww.lakemedelsverket.se%2FTpl%2FNewsPage____3227.aspx As of February 15, 2006, Mr Christer Backman will act as the MPA’s EU coordinator and Policy Advisor. (Source: MPA RSS news -) MPA RSS news - news http://www.medworm.com/rss/comments.php?id=566760 Mon, 13 Mar 2006 05:00:00 +0100 566760