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Parallel importer obliged to report adverse drug reactions

Baker & McKenzie
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Sweden
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November 19 2012

On 21 July 2012 the Swedish Medical Products Agency ("SMPA") enacted new Codes of Stature in terms of adverse drug reaction reporting systems for parallel imported drugs (LVFS 2012:19, the "Code"

New government agency structure; major changes ahead

Baker & McKenzie
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Sweden
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July 2 2012

The Swedish Government's Healthcare and Social Services Inquiry (the Inquiry) has announced a new proposal to address a number of challenges facing the healthcare sector in the years ahead

Swedish initiative to complement the EU guidelines on the classification of stand alone software

Baker & McKenzie
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Sweden
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July 2 2012

For some years, stand alone software used for medical purposes has been categorised as a medical device

The Swedish Data Inspection Board examines record blocks in all counties

Baker & McKenzie
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Sweden
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September 21 2011

A patient's ability to block information in their records is now being examined in a comprehensive review of all counties and five of the largest private healthcare providers

Cloud computing and the laboratory

Bird & Bird
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Sweden
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May 3 2011

InSweden, electronic documentation and management systems are today more or less mainstay in the modern infrastructure within the Life Science sector (the notion life science used here in its broadest meaning, including the food & beverage and chemical sector

Swedish Court of Appeal reverses preliminary injunction decision while taking into account a request for reformulation of patent claims during preliminary injunction proceedings

Bird & Bird
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Sweden
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January 31 2011

McNeil AB is the owner of an EP patent, valid in Sweden, for a liquid pharmaceutical formulation comprising nicotine for the administration to the oral cavity

One year after de-monopolisation

Bird & Bird
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Sweden
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October 21 2010

On 1 July 2009, Sweden implemented the Act on Sales of Medicinal Products, (2009:366) (ASMP) which allows entities other than the state-owned Apoteket AB to own and operate pharmacies

Sweden

Advokatfirman Lindahl
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Sweden
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September 22 2010

In Sweden, pharmaceutical trademarks are governed by trademark law and also, to some extent, by sector-specific regulation

Clarification of obligation to perform clinical evaluations

Bird & Bird
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Sweden
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July 28 2010

New rules and regulations concerning medical devices entered into force in Sweden on 21 March 2010

Free movement of medical devices bearing CE marking

Bird & Bird
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European Union, Sweden
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July 28 2010

The CJEU recently interpreted Article 4 of Directive 9342CEE on medical devices in response to a preliminary reference laid before it

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Parallel importer obliged to report adverse drug reactions

New government agency structure; major changes ahead

Swedish initiative to complement the EU guidelines on the classification of stand alone software

The Swedish Data Inspection Board examines record blocks in all counties

Cloud computing and the laboratory

Swedish Court of Appeal reverses preliminary injunction decision while taking into account a request for reformulation of patent claims during preliminary injunction proceedings

One year after de-monopolisation

Sweden

Clarification of obligation to perform clinical evaluations

Free movement of medical devices bearing CE marking

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