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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, particularly on those 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 2016

In 2016, three MSSs, a Market Surveillance Study on Telmisartan APIs and Tablets (MSS046), an MSS on Pramipexole APIs and Tablets (MSS047) and an MSS on Irbesartan APIs and Tablets (MSS049) were finalised. The testing phase of one MSS launched in 2015 on Subdivision of Tablets (MSS048) was also completed.

An average of 18 OMCLs from the General European OMCL Network participated in these studies.

Four other new MSSs on Foreign Matter in Herbal Drugs (MSS051), Repaglinide Tablets (MSS052), Leflunomide Tablets (MSS053) and Hyaluronic acid-based Dermal Fillers (MSS050) were initiated. The latter was the second MSS focused on Medical Devices organised within the Network.

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