Investigational medicinal products, unauthorised ancillary medicinal products and authorised ancillary medicinal products subject to a modification that does not require a marketing authorisation

Royal decree amending the Royal Decree, of 9 October 2017, implementing the Law, of 7 May 2017, on clinical trials of medicinal products for human use

This draft royal decree makes the distribution of investigational medicinal products, unauthorised ancillary medicinal products and authorised ancillary medicinal products subject to a modification that does not require a marketing authorisation, used in the context of clinical trials, subject to an authorisation for distributors established in Belgium. It regulates the conditions and procedures for obtaining and maintaining the authorisation. The draft decree also establishes the rules to be followed by the distributor established in Belgium or in another Member State. This notification follows the amendment of the draft submitted under procedure TRIS 2025/0323/BE.