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.
EMA IT systems unavailable from 30 October to 3 November 2015
Monday, October 26, 2015
All European Medicines Agency (EMA) IT systems will be temporarily unavailable from 20:00 on Friday 30 October to 6:00 on Tuesday 3 November (UK time), due to an essential exercise to test the Agency’s IT recovery processes.
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 Director General for the Swedish Medical Products Agency
Friday, October 03, 2014
The Swedish Government has appointed Catarina Andersson Forsman, MD, PhD, as Director General for the Swedish Medical Products Agency.
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.
Shut down SweWeb web application
Thursday, February 27, 2014
The Swedish Medical Products Agency (MPA) has made a decision on February 25th 2014 to terminate the web application SweWeb.
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.
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.