European News Updates

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These European updates are some of the recent key regulatory news items we have noted, including those from the regulatory agencies and authorities in Europe. A two-letter code is used at the beginning of each item to indicate the country or region, according to the ISO list.

[DK] Danish Medicines Agency: About gold dental crowns from Oversea Labs: Experts assess there to be no health risk associated with the dental crowns

On 29 August, DR TV (Danish Broadcasting Corporation) broadcast a story on the Danish company Oversea Labs, revealing that the company’s gold dental crowns according to DR’s analysis of five teeth did not contain as much gold as they were supposed to. The Danish Medicines Agency now follows up on the case.

[DK] Danish Medicines Agency: Sales of head lice medicines

First day at school when kids meet up after summer marks the prime time for head lice infestation.While the lice are no doubt still to be found in Danish scalps, sales data show that the Danes are increasingly turning away from medical therapies to treat a lice attack.

[UK] MHRA: Draft consolidated UK medicines regulations

The MHRA has published a working draft of the consolidated UK medicines regulations.

As announced previously, the MHRA is undertaking a consolidation and review of medicines legislation. The aim of the project is to ensure that the legislative framework for medicines is comprehensive, comprehensible and fit for current purpose.

[DK] Danish Medicines Agency: EudraCT portal unavailable 2 - 7 September 2010

The EudraCT website will be unavailable from Thursday 2 September to Tuesday 7 September 2010 for the rollout of EudraCT version 8.0.

[DK] Danish Medicines Agency: The Danish Medicines Agency’s expectations for audits of API manufacturers

As part of the final batch release of a medicinal product, the qualified person (QP) must make sure that active pharmaceutical ingredients (API) are manufactured in compliance with the EU good manufacturing practice (GMP) as well as any terms stipulated in a marketing authorisation, if relevant. In this connection, the qualification of API manufacturers is the responsibility of the qualified person. However, most concrete tasks related to the qualification can be delegated to sufficiently qualified staff.

[EU] EMA: News and Press Releases European Medicines Agency starts review of Pandemrix

Agency is investigating whether there is a link between vaccine and cases of narcolepsy

[SE] MPA: Current information on the investigation of cases of narcolepsy after vaccination with Pandemrix

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.

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The European Medicines Agency on Twitter

The European Medicines Agency have created a news feed on Twitter (https://twitter.com/EMA_News). However, some companies have chosen to block access to Twitter for employees. To help regulatory professionals in those companies, we render recent items from their news feed on our site, for accessibility.