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: Much debated dental crowns pose no health risk

On 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 FAQs

To 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.

[EU] EMA: Final opinion of the HMPC on a community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos, adopted

The European Medicines Agency have published: Final opinion of the HMPC on a community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos, adopted

[EU] EMA: Final assessment report on Valeriana officinalis L., radix and Humulus lupulus L., flos, adopted

The European Medicines Agency have published: Final assessment report on Valeriana officinalis L., radix and Humulus lupulus L., flos, adopted

[EU] EMA: Overview of comments received on community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos

The European Medicines Agency have published: Overview of comments received on community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos

[EU] EMA: Final list of references supporting the assessment of Valeriana officinalis L., radix and Humulus lupulus L., flos, adopted

The European Medicines Agency have published: Final list of references supporting the assessment of Valeriana officinalis L., radix and Humulus lupulus L., flos, adopted

[IE] IMB: Guide to Submitting a Request for Ireland to act as RMS in a Decentralised Procedure for a Human Medicinal Product

The Irish Medicines Board have published: Guide to Submitting a Request for Ireland to act as RMS in a Decentralised Procedure for a Human Medicinal Product

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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.