GMP Committee response
29/06/2020 14:07
The CE marking requirements should be uniformly applied across the EU, UK and EEA countries.
CE marking requirements do not apply to medicinal products, but administration sets are Class I medical devices.
The sodium chloride solution in the bag (as its container-closure system) would be a medicinal product and as such does not need a CE mark.
However, the pharmacopoeial monograph for sodium chloride for infusion is not formally harmonized across EU and US and, even if the product is the same, the labeling will differ, so this would be an unlicensed medicinal product in Europe.
The rules for importation and use of unlicensed medicinal products do differ between European countries.
We would not generally recommend use of unlicensed medicinal products in clinical trials unless they are an IMP subject to investigation, included in the IMPD/CTA and with an EU batch release site. However, given the current challenges to pharmaceutical supply chains arising from COVID-19, regulators are showing flexibility and allowing alternative sources. Requirements should be checked with the national regulator(s) relevant to the intended clinical sites.
It would also be advisable to check with clinical sites for compatibility with their administration sets and to ensure that they are aware of the differences in labeling.
