Requirements for marketing authorisation holders for medicinal products containing active substances in the form of mesilates, (di)isetionates, tosilates or besilates

25 September 2008, Updated 23 May 2016
The Danish Medicines Agency draws attention to an announcement from CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human).

The CMDh has requested marketing authorisation holders to undertake a risk assessment on the occurrence of contamination with mesilate esters and related compounds in certain medicinal products.

If such risk assessment concludes that there is a risk of contamination, a variation application must subsequently be submitted to ensure that this risk is eliminated and/or adequately controlled. The risk assessment should be made available to the Danish Medicines Agency upon request.

For more detailed information, please see the announcement on the website of the CMDh, which can be downloaded in the box to the right.

For further information, please contact Gorm Herlev Jørgensen, tel.+45 4488 9288 or e-mail gj@dkma.dk.

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