Manufacturing / Import
CardioSec has a manufacturing authorisation as well as an import license according to European regulations for IMPs and NIMs*.
We manufacture, label or blind your test products or import and release them from countries outside the EU on short notice.
*"Products which are not IMPs as referred to in Art. 2(d) of Directive 2001/20/EC may be supplied to subjects participating in a trial and used in accordance with the protocol. For instance, some clinical trial protocols require the use of medicinal products such as concomitant or rescue/escape medication for preventive, diagnostic or therapeutic reasons and/or to ensure that adequate medical care is provided for the subject. They may also be used in accordance with the protocol to induce a physiological response.
These medicinal products do not fall within the definition of investigational medicinal products in Directive 2001/20/EC and can be referred to as “non-investigational medicinal products” (NIMPs)." Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials, Volume 10 Clinical Trials Notice to Applicants IMPs and NIMPs
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