No Medical Product may be manufactured in the State for marketing therein, except after obtaining Marketing Approval from the EDE, provided that it is manufactured in a factory licensed in the State, in accordance with the controls and standards contained in Article (126) of this Decree-Law. The Executive Regulations of this Decree-Law shall specify the conditions and controls for licensing a locally manufactured product designated for export purposes without marketing it within the State.
Interpretation and application must be checked against the official text and current version.