Information on Single assessment and Worksharing for periodic safety update reporting
Friday, April 26, 2013
Updated information on the EURD list and worksharing is available on the MPA website.
Pharmaceutical ingredients in one out of three eyelash serums
Monday, April 15, 2013
The Swedish Medical Products Agency’s analyses of eyelash serums/eyelash growth products have now been completed. Prostaglandin analogues were found in as many as nine of the 26 products in total. In three of the products prostaglandin analogues were not declared on the packaging. Prostaglandin analogues are added to stimulate eyelash and eyebrow growth. The Swedish Medical Products Agency advises consumers not to use products containing prostaglandin analogues, as this may lead to serious side effects.
Registry study confirms increased risk of narcolepsy after vaccination with Pandemrix in children and adolescents and shows an increased risk in young adults
Tuesday, March 26, 2013
A large Swedish registry study confirms the increased risk of narcolepsy after vaccination with Pandemrix in subjects 20 years and younger. The study also shows an increased risk in young adults (21-30 years). The risk declines gradually with increasing age. No associations with increased risks were concluded for any of the other studied neurological and immune related diseases.
The MPA focuses on eyelash growth serum
Tuesday, March 05, 2013
The Swedish Medical Products Agency is concerned by the fact that eyelash growth products may contain prohibited substances known as prostaglandin analogues. This type of substance may give rise to serious side effects and there is a keen interest among consumers to buy and use this type of products. Consequently, the MPA will take a broader approach during 2013, by mapping the Swedish market, acquiring and analysing relevant products and communicating analysis results.
Guidance for qualification and classification of Medical Information Systems
Thursday, January 31, 2013
Standalone software with a medical purpose has a central role in health care. Depending on the application, they may be subject to the requirements of the medical device regulation. MPA has developed a guide for standalone software with medical purposes in support of manufacturers, health care providers and government agencies.
Information regarding the exemption application
Tuesday, June 19, 2012
The 18 Juni 2012 MPA has concluded that allowing parallel sales of packs of old and new label for a maximum of 6 months, regarding MAH transfers / Agent changes.
New guide for manufacturers of standalone software
Tuesday, June 12, 2012
The European Commission has adopted a guide for manufacturers of standalone software that describes the criteria for whether a product is considered a medical device and thus should be CE-marked. In this article, the MPA provides an introduction to the guide. In addition, work has now begun to update the 2009 Swedish guide on Medical Information Systems.
Position of the MPA regarding Lucentis and Avastin
Friday, March 16, 2012
Lucentis (ranibizumab) is approved for the treatment of neovascular age related macular degeneration (AMD), for the treatment of visual impairment due to diabetic macular oedema (DME) and retinal vein occlusions (RVO).
Changes in procedure for requesting Sweden as RMS in DCP
Monday, March 12, 2012
The Swedish Medical Products Agency participates actively in the decentralised procedure as reference member state (RMS) and has since the start received a high number of requests for time slots.
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.