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 2018, 4 MSSs, a Market Surveillance Study on Hyaluronic acid-based Dermal Fillers (MSS050), an MSS on Foreign Matter in Herbal Drugs (MSS051), an MSS on Zoledronic acid Preparations for Parenteral Application (MSS055) and an MSS on Meloxicam APIs and Solutions for Injection (MSS056) were completed.
Two other new MSSs on Liothyronine API and tablets (MSS054) and on Pioglitazone Tablets (MSS057) were initiated.
An average of 9 OMCLs from the General European OMCL Network participated in these studies.
End of 2018, 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.