The MPA initiates research on vaccine safety and narcolepsy
Thursday, February 02, 2012
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.
5,7 million Euro to Swedish research on environmental impact of pharmaceuticals
Wednesday, October 05, 2011
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.
Swedish initiative for green medicine production
Monday, July 04, 2011
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.
Cooperation agreement finalised with Brazil’s medical products agency ANVISA
Monday, July 04, 2011
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.
Report from an epidemiological study in Sweden on vaccination with Pandemrix and narcolepsy
Thursday, June 30, 2011
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.
Changes in procedure for requesting Sweden as RMS in DCP
Tuesday, April 05, 2011
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.
Strengthened evidence of an association between vaccination with Pandemrix and narcolepsy in children and adolescents
Tuesday, March 29, 2011
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.
Variations - Worksharing for purely nationally authorised products not accepted
Monday, January 17, 2011
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.
Pilot project of joint scientific advice - outcome of the evaluation
Tuesday, December 21, 2010
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.
Pilot project of joint scientific advice meetings will be evaluated
Monday, October 04, 2010
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.
The New Organisation at the Swedish Medical Products Agency
Monday, September 13, 2010
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.
Update on the investigation of narcolepsy cases in Sweden
Friday, September 10, 2010
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.
Variations for Medicinal Products authorised by purely national procedure
Friday, September 03, 2010
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.
Current information on the investigation of cases of narcolepsy after vaccination with Pandemrix
Thursday, August 26, 2010
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.
The MPA investigates reports of narcolepsy in patients vaccinated with Pandemrix
Wednesday, August 18, 2010
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.
The MPA is reorganising
Monday, June 28, 2010
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.
Final summary of ADR reports in Sweden with Pandemrix
Wednesday, June 02, 2010
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.
New routines in Sweden for handling recalls of medicinal products from the 15th of March, 2010
Wednesday, March 17, 2010
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).
New information on the website due to new variation regulation
Friday, February 26, 2010
The webpage on variations has been extensively updated with new information regarding the handling of variations in accordance with the new variation regulation.
MPA to lead European collaboration on drug effectiveness
Monday, February 01, 2010
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".