Licensed medicinal products
Is it necessary to submit the SmPC for all authorized IMPs for a CTA?
Yes, for the authorisation of clinical trials in humans with authorized investigational medicinal products which do or do not meet the conditions of authorisation (indication, type of application, dose range), SmPCs (in English and German) must be submitted. If the intended use of a medicinal product does not meet the conditions of authorisation, a detailed assessment of risks and benefits considering the safety margins of preclinical findings should be given additionally.
Are there any requirements if the route of administration (e.g. oral to dermal) of an authorized investigational medicinal product is changed?
Yes, it may be necessary to submit additional information on local tolerance for the new route of substance administration. In any case, a risk-benefit assessment has to be submitted on the basis of systemic exposure.