This activity involves the General European OMCL Network only.
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.
In 2020, the Market Surveillance Study on Sildenafil APIs and Finished Products (MSS058) was finalised. Twenty-four OMCLs from the General European OMCL Network from 22 European countries plus Australia and Israel participated in the study, in which more than 340 samples were analysed.
End of 2020, ISO 9001-compliance of the EDQM’s coordination activities with respect to the CAP, MRP/DCP and MSS Programmes was re-certified by AFNOR Certification.