1. Approval for Emergency Use of a Medical Product shall be issued in accordance with the following conditions: a. There is evidence of the effectiveness of the Medical Product in diagnosing, treating or preventing the diseases involved in the emergency health condition. b. Providing evidence that the known and potential benefits of the Medical Product outweigh its risks. c. The lack of adequate, approved and available alternatives to the Medical Product for the diagnosis, prevention or treatment of the diseases involved in the emergency health condition. d. The presence of data from Clinical Research, Clinical Trials or any other reference sources that prove the safety and effectiveness of the Medical Product. e. Having a plan in place to monitor the use of the Medical Product and manage any risks associated with its use. f. Any other conditions determined by the Executive Regulation of this Decree-Law. 2. Approval for Emergency Use of a Medical Product shall be issued in accordance with the following controls: a. Pharmaceutical and Health Establishments in the State that handle the Medical Product that has received Emergency Use approval shall comply with the instructions issued by the EDE concerning uses and dosages. b. Any other controls determined by the Executive Regulation of this Decree-Law. 3. As an exception to Clause (2) of Article (6), and in the event that the State is exposed to a health pandemic that is declared in accordance with the legislation in force in this regard, the EDE may grant approval for Emergency Use and a permit to import the similar product before the expiration of the legal protection period for the reference innovative product.
Interpretation and application must be checked against the official text and current version.