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Market Surveillance Studies

This activity involves the General European OMCL Network only.

Background

Market Surveillance Studies (MSS) are carried out on commercialised medicines having a national marketing authorisation. Products are tested according to a common protocol and on the basis of national sampling procedures. To ensure that the same types of medicines are of comparable quality in the different member states, these studies are multilateral. Several are organised yearly. They look at different types of finished products for a given active substance and at herbal drugs.


Where a need is identified, the results of these studies could support revision of the relevant European Pharmacopoeia monographs and/or general chapters and methods.


Achievements in 2013

In 2013, two MSS were initiated, a Market Surveillance Study on Heparin and Low Molecular Mass Heparin APIs and Finished Products and a Market Surveillance Study on Eye Drops and Nasal Preparations registered as Medical Devices.

 

An average of 7 OMCLs from the General European OMCL Network participated in these studies.

 

The study on Dietary Slimming Supplements (MSSIP001) was also finalised. Details on the outcome of the study, including the origin of the samples analysed and the undeclared active substances detected, can be found in the section Testing of counterfeit/illegal medicines within the GEON.


 

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