1. The EDE may suspend the circulation of the Medical Product if it is necessary to confirm information indicating its lack of quality, safety or effectiveness. The EDE shall issue a decision to withdraw the entire Medical Product or batches thereof within (30) thirty days from the date of suspension, in any of the following cases: a. If the Medical Product is proven to be adulterated or does not conform to the quality, safety of use or effectiveness specifications approved by the EDE. b. If the Medical Product is proven to be toxic or harmful under the conditions of use recommended by the manufacturer or marketer. c. If an unexpected or serious side effect or an unexpected or serious adverse reaction to the Medical Product is proven to have occurred after its use under the conditions of use recommended by the manufacturer or marketer. d. If the Marketing Approval for the Medical Product is cancelled in accordance with the provisions of Article (17) of this Decree-Law, or its production is stopped in the reference country for reasons related to the quality of the product. e. If it is proven that the Marketing Approval for the Medical Product was granted on the basis of incorrect documents or data or on the basis of the use of illegal methods. f. If any of the cases mentioned in Article (15) of this Decree-Law arise, without a new Marketing Approval or a new conditional Marketing Approval issued by the EDE. g. If any of the cases mentioned in Article (16) of this Decree-Law arise without the approval issued by the EDE and it is proven after the EDE assessment that it is necessary to withdraw the Medical Product. h. If he violates any of the conditions specified in this Decree-Law, its Executive Regulations, and the decisions issued in implementation thereof. 2. The EDE shall confirm the existence of the cases referred to in Clause (1) of this Article, by investigating and confirming their validity and accuracy with the relevant pharmaceutical or Health Establishments, conducting announced and unannounced inspections, taking samples, and requesting relevant information and documents. 3. In all cases, the EDE, the Ministry, the Competent Health Authority and health professionals shall coordinate with each other concerning any measures taken in accordance with this Article. The Ministry or the Competent Health Authority also has the right to suspend the Medical Product in Pharmaceutical Establishments, Biobanks, and government and private Health Establishments licensed by it, while committing to informing the EDE in the manner specified in the Executive Regulations of this Decree-Law.
Interpretation and application must be checked against the official text and current version.