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 2021

In 2021, two Market Surveillance Studies were launched:

Tadalafil APIs and Tablets (MSS059)

This study is combined with an MSS Fingerprint study. The “classical” MSS focuses on the testing of key parameters of API samples and Tadalafil generics product samples with the goal to assess their compliance with the authorised specifications.

Breaking of Glass Ampoules (MSS061)

This study is based on signals reported by an OMCL from their national market. The findings were related to glass fragments found in liquid dosage forms filled in glass ampoules with one-point cut systems after opening. As this was considered as a potential issue applicable to all markets, it has been decided to carry out a Network-wide study dedicated to this topic.

The EDQM’s coordination activities with respect to the MSS “classical” Programme are ISO 9001 certified by AFNOR Certification and audited on a regular basis. The last audit took place in February 2022.