|
|
[DK] Danish Medicines Agency: Danish Pharmacovigilance UpdateThe newsletter Danish Pharmacovigilance Update puts focus on medicine and its side effects. The purpose of Danish Pharmacovigilance Update is to give primarily doctors quick and easy access to the most important information about medicine and side effects. [NL] MEB: Suspension of medicinal products containing cyclosporineBased on a decision by the European Commission the Medicines Evaluation Board has suspended the marketing authorisation of six medicinal products containing cyclosporine with immediate effect. Subsequent to assessment of a new bioequivalence study the suspension of the marketing authorisation may be lifted. [DK] Danish Medicines Agency: EudraCT portal available 2 - 7 September 2010We have previously stated that the EudraCT portal would be unavailable 2 - 7 September 2010. However, the planned deployment of EudraCT Version 8 is delayed, and the portal will remain available in the period mentioned. [NL] MEB: Publication on investigation into the implementation of pregnancy prevention programmes for isotretinoin in EuropeThe implementation process for the pregnancy prevention programme (ZPP) for isotretinoin in Europe is still lacking. This became clear from a literature review analysing studies that have been carried out. Therefore treatment with isotretinoin must be researched in even greater detail for the pregnancy prevention programme to see whether any measures should be taken, bearing the eventual aim and disadvantages of use in mind. [NL] MEB: 20 August 2010 – Monthly update: state of affairs concerning backlogsThe backlogs in implementation of European procedures slightly decreased in the past month, while the backlogs in national procedures increased somewhat. [DK] Danish Medicines Agency: Much debated dental crowns pose no health riskOn 29 August, DR TV (Danish Broadcasting Corporation) broadcast a story on the Danish company Oversea Labs about gold dental crowns. The test results presented by DR have now been reviewed by the independent Nordic Institute of Dental Materials (NIOM). The results revealed a lower gold content than what could be expected based on information from the company. [UK] MHRA: Variations legislation 2010 - details of our experience to date, submissions audit and update to FAQsTo help ensure that companies are submitting the new Type IA notifications correctly we have published details of our experience to date, an audit of submissions made in June 2010 and also updated the FAQs. |
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