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Market Surveillance Studies (MSS)

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 2015

In 2015, two MSSs, a Market Surveillance Study on Heparin and Low Molecular Mass Heparin APIs and Finished Products (MSS044) and a Market Surveillance Study on Eye Drops and Nasal Preparations registered as Medical Devices (MSS045) were finalised. The latter was the first MSS focused on Medical Devices organised within the Network.

The testing phase of two MSS launched in 2014 on Telmisartan APIs and Tablets (MSS046) and Pramipexole APIs and Tablets (MSS047) was also completed and two other new MSS on Subdivision of Tablets (MSS048) and an MSS on Irbesartan APIs and Tablets (MSS049) were initiated.

An average of 14 OMCLs from the General European OMCL Network participated in these studies.

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