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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 2009
In 2009, the study on omeprazole gastro-resistant tablets and capsules was finalised. Studies were initiated for the following products:
- levothyroxine tablets;
- morphine oral retard products; and
- simvastatin tablets.
The studies on levothyroxine tablets, simvastatin and morphine oral retard products are in the testing phase. At the annual meeting of the OMCL Network held in Vienna, an MSS on acetylsalicylic acid preparations was agreed upon.
In 2009, an average of 17 OMCLs from the General European OMCL Network participated.
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