The Marketing Approval or conditional Marketing Approval issued by the EDE is considered invalid and the Marketing Right Holder may not use it. He shall reapply for a new Marketing Approval or conditional Marketing Approval for the same Medical Product, in any of the following cases: 1. Substantial changes in the composition or formulation of a Medical Product. 2. Significant changes in dosage form or concentration. 3. Changes in the classification of the Medical Product type or its route of administration, which were not included in the current Marketing Approval or conditional Marketing Approval. 4. Significant changes in the manufacturing and production process that may affect the quality, safety or effectiveness of the Medical Product. 5. Fundamental changes in medical device design. 6. Voluntarily withdraw a Medical Product from the market for later re-introduction with significant changes. 7. Results of pharmacovigilance operations, whether due to new safety concerns or reports of adverse reactions or medical events that require withdrawal or re-assessment and significant changes to the Medical Product. 8. 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.