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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 2011
In 2011, the studies on opioid modified release oral products and simvastatin tablets were concluded. The testing phase was carried out for the following products:
• APIs and medicines containing mesilates salts
• Acetyl salicylic acid oral products and
• Clopidogrel APIs and tablets.
An average of 18 OMCLs from the General European OMCL Network participated in these studies.
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