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.
Achievements in 2017
In 2017, three MSSs, a Market Surveillance Study on Subdivision of Tablets (MSS048), an MSS on Repaglinide Tablets (MSS052) and an MSS on Leflunomide Tablets (MSS053) were finalised.
The testing phase of two MSS launched in 2016 on Foreign Matter in Herbal Drugs (MSS051) and Hyaluronic acid-based Dermal Fillers (MSS050) was also completed.
Two other new MSSs on Zoledronic acid Preparations for Parenteral Application (MSS055) and on Meloxicam APIs and Solutions for Injection (MSS056) were initiated.
An average of 12 OMCLs from the General European OMCL Network participated in these studies.
Further details will be provided in the full annual report of activities.
End of 2017, 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.
Status December 2017