The LMI Rules for Marketing of Medicinal Products were revised in November 2013. There is no impact on the conduct of non-interventional studies as “clinical trials, including non-intervention trials, do not lie within the scope of the Rules”. 
Pharmaceutical companies must nonetheless meet the requirements regarding the publishing of information about clinical trials; see “Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases” and “Joint Position on the Publication of Clinical Trial Results in the Scientific Literature”.
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Note – The 2008 LMI Guidelines for Non-Interventional Studies have not been amended and still remain in force
