All news


Number of news: 95

The Administrative Court rejects Draeger Medical System Inc’s appeal

Friday, November 23, 2018

On May 4, 2018, the Swedish Medical Products Agency, MPA, made the decision to prohibit the jaundice meter Dräger JM-105 from the Swedish market until the meter's display of high bilirubin values was modified. Furthermore, the display of all JM-105 products already on the market had to be modified, or withdrawn from the Swedish market before Oct. 31, 2018. The company, Draeger Medical Systems System Inc., appealed against the MPA’s decision. The appeal is now rejected by the Administrative Court.

The assessment of Natural Cycles is completed

Thursday, September 13, 2018

On request of the Swedish Medical Products Agency, the manufacturer Natural Cycles has now clarified the risk of unwanted pregnancies in the instructions for use (IFU) and in the app. Thereby, the Swedish Medical Products Agency has no further remarks and the assessment is completed.

Substances that may require child-resistent packages

Monday, June 11, 2018

The Swedish Medical Products Agency has prepared a list of substances used in medicines where the observation or treatment in hospital of a child is warranted after intake of a limited amount (e.g. a single tablet). For medicinal products containing these substances the Swedish Medical Products Agency may require a child-resistant package, unless it can be considered that the pharmaceutical dosage form or the formulation itself reduces the risk.

Reference Safety Information - new Q&A document published

Thursday, January 11, 2018

The Q&A–RSI document of the Clinical Trial Facilitation Group (CTFG) has been updated and published at the website of the Head of Medicines Agencies under the heading key documents list, clinical trials safety.

New revision of the template for Risk Management Plan

Monday, August 07, 2017

On the 30th of March 2017, EMA published the second revision of the RMP template, which marketing authorisation holders and applicants can use for all RMP submission as of 31 March 2017. The second revision becomes mandatory for all RMP submissions as of 31 March 2018.

Checklist for Swedish product information

Friday, November 25, 2016

For the submission of Swedish product information (SmPC, Package Leaflet and Labelling) the MPA has developed a Checklist to support the Applicant.

Requirements regarding safety features for packages for medicinal products

Wednesday, September 28, 2016

A new framework regarding requirements for a unique identifier for human medicinal products packages will come into force in Sweden February 9th 2019. Packages concerned by the requirements shall bear a unique identifier and an anti-tampering device allowing the verification of whether the packaging has been tampered with.

Periodic Safety Update Report (PSUR) submissions shall be submitted directly to EMA as of June 13, 2016

Wednesday, June 01, 2016

As of June 13, it is mandatory for Market Authorizing Holders (MAH) in Sweden to submit PSUR directly to the PSUR Repository database at the EMA.

The MPA reports: The impact of medical products on the Swedish environmental goals

Thursday, March 03, 2016

The Swedish Medical Products Agency has investigated how production and use of medicines, medical devices, cosmetics and tattoo ink affect the Swedish environmental goals, as defined by the Swedish government. The report calls for greater consideration of environmental issues, greater collaboration and development of international regulation.

New Legal Framework for Medicines in Sweden

Monday, February 01, 2016

As of 1 January 2016, Sweden has a new legal framework for medicines. The new laws and regulations do not incur any significant changes other than structure and wording.

The Electronic Application Form is now mandatory

Thursday, January 14, 2016

The Electronic Application Form (eAF) is now mandatory to use for all new Marketing Authorisation Applications, Renewals and Variations within all procedures regarding medicinal products.

Paracetamol tablets only available in pharmacies

Friday, October 30, 2015

As of 1st of November 2015, non-prescription tablets of paracetamol will no longer be available in Sweden at non-pharmacy outlets. The decision was taken in April 2015 by the Swedish Medical Products Agency (MPA), and refers to tablets intended for swallowing whole. Other forms of paracetamol are not affected, e.g. in liquid form or as effervescent tablets.

MPA's contributes to a positive change in the use of medicines for children

Friday, October 23, 2015

Children have a right to safe and effective use of well-documented medicines. Efforts are made both on international and national levels to increase the development of medicines for children, but these changes take time. In 2011 the MPA was assigned a government commission as a part of the National Pharmaceutical Strategy, "Expand the knowledge of paediatric medicines and their use".

New guideline for labelling and package leaflets of medicinal products

Friday, July 11, 2014

The MPA has updated the common guideline for the labelling and package leaflets for medicinal products. The guideline provides explanations and examples of how the current regulations should be interpreted. The purpose of the regulations is to ensure that patients receive clear and relevant information, and reduce the risk of confusion and misuse.

The Nordic Medicinal Agencies release Guidance on Nordic packages

Friday, February 21, 2014

The new documents Guideline on Nordic packages and Frequently Asked Questions have been prepared in order to facilitate the regulatory work when making common Nordic medicinal packages.

Warning regarding slimming products containing dinitrophenol

Wednesday, September 18, 2013

The Swedish Medical Products Agency and the Swedish National Food Agency hereby issue a warning regarding the substance 2,4 Dinitrophenol, also known as DNP. This substance has been found in the slimming product Pure Caffeine 200, which can be bought through foreign Internet webshops. DNP has caused severe cases of acute toxicity and death.

Revised classification guideline for variation applications

Thursday, July 18, 2013

The European Commission’s guideline for classification of variation applications has been revised and the new classifications apply from 4 August 2013. The purpose of the revision is to reflect changes in the legislation and experience acquired in the application of variation classifications since 2010. Some new classifications have been added and others have been adjusted in content.

PIP implants should be removed for preventative reasons

Tuesday, June 04, 2013

Breast implants manufactured by Poly Implant Prothèse (PIP) have a poorer mechanical durability and, in a number of cases, contain an irritant substance in significantly higher levels than other silicone breast implants. The Medical Products Agency and the National Board of Health and Welfare therefore recommend that clinics that have, in the past, used PIP implants inform the women affected of these risks and also that PIP implants should be removed for preventative reasons, except in individual cases where there are medical reasons for not doing so.

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.

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.


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