1. The EDE establishes a fast track with simplified procedures in line with quality, safety, efficacy requirements and international agreements, to grant Marketing Approvals for innovative Medical Products of therapeutic importance. 2. The Executive Regulations of this Decree-Law shall specify other Medical Products permitted to be included in the fast track and the terms, controls and requirements for submitting a request for Marketing Approval within this track.
Interpretation and application must be checked against the official text and current version.