Article 61 requires manufacturing and import of investigational medicinal products to be subject to authorisation by the Member State of manufacture/import. Article 62 sets the responsibilities of the qualified person (QP) for IMP release. Article 63 sets the GMP requirements for the manufacture and import of IMPs (the Commission has adopted the IMP-specific GMP via Commission Delegated Regulation (EU) 2017/1569 + the EU GMP Guide Annex 13).
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.