Non-Clinical and Clinical Research Entities may not: 1. Practicing any activity not licensed. 2. Conducting any clinical or non-Clinical Research without obtaining the necessary approvals in accordance with the relevant legislation. 3. Importing or exporting biological samples without obtaining the approval of the Competent Health Establishment or Authority, each within the limits of their jurisdiction. 4. Dealing with other unlicensed Pharmaceutical Establishments or Biobanks. 5. Any other prohibitions contained in the executive regulations of this Decree-Law or in the legislation regulating this regard or in the local legislation in force in this regard.
Interpretation and application must be checked against the official text and current version.