1. The Ministry or the Competent Health Authority, each within their jurisdiction, shall issue a decision to temporarily suspend the License of the Non-Clinical and Clinical Research Entity for a period not exceeding one month, in any of the following cases: a. Withdrawal, cancellation or non-renewal of the Good Clinical Practice Certificate. b. Transferring Ownership of Non-Clinical and Clinical Research Entity to another person without the approval of the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. c. Transferring Ownership of Non-Clinical and Clinical Research Entity to another person without the approval of the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. d. The absence of qualified persons for direct supervision and control in accordance with the rules in force in this field. e. Proof that the Non-Clinical and Clinical Research Entity used forged documents and papers while practicing their licensed activities. f. Committing the prohibitions mentioned in Clauses (4) of Article (150) of this Decree-Law. g. Committing a violation that requires the Temporary Closure of the Non-Clinical and Clinical Research Entity, as determined by the Executive Regulations of this Decree-Law or the local legislation in force in this regard. 2. The EDE or the Competent Health Authority, each within their jurisdiction, shall issue an immediate decision to close the Non-Clinical and Clinical Research Entity as precaution if its continued operation poses a risk to public health or results from its commission of violations that require precautionary closure, as determined by the Executive Regulations of this Decree-Law or the local legislation in force in this regard. 3. In all cases, the matter shall be referred to the committee referred to in Clause (2) of Article (160) of this Decree-Law, within (7) seven working days from the date of the Temporary Closure, to consider it and decide on disciplinary responsibility, within a period not exceeding (10) ten working days from the date of referring the matter to it.
Interpretation and application must be checked against the official text and current version.
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