The Marketing Right Holder shall submit a request for minor changes to the Medical Product to the EDE without the need to submit a new request for Marketing Approval of all types as referred to in Article (15) of this Decree-Law, in any of the following cases: 1. Any minor changes in the composition of the Medical Product or in the event of new uses for the Medical Product, whether as new indications for use or suitability for a new category of patients. 2. Any change in the appearance of the Medical Product or its internal leaflet. 3. Any change in the location of the Medical Product manufacture or in the Marketing Rights holder, or minor changes in the method of its manufacture. 4. Any other cases determined by the Executive Regulation of this Decree-Law.
Interpretation and application must be checked against the official text and current version.