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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 2014

In 2014, the testing phase of two MSS initiated in 2013, 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) was finalised. In addition, two additional MSS on Telmisartan Tablets and APIs (MSS046) and Pramipexole Tablets and APIs (MSS047) were launched. An average of 13 OMCLs from the General European OMCL Network participated in these studies.

 

The testing phase of the market surveillance of Dietary Supplements advertised as Sexual Potency Enhancers (MSSIP002) was also finalised in 2014. Details on the outcome of the study, including the origin of the samples analysed and the undeclared active substances detected, will be made available in future in the section  Testing of counterfeit/illegal medicines within the GEON. A third Market Surveillance of Suspected Illegal Products, focused on Illegal Anabolics (MSSIP003) was also organised.

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