1. The Ministry or the Competent Health Authority, each within their jurisdiction, shall issue a decision to temporarily suspend the License of Contractual Company for Research and Development 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 Contractual Company for Research and Development 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 Contractual Company for Research and Development to another place without the approval of the EDE 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 Contractual Company for Research and Development used forged documents and papers while practicing their licensed activities. f. Committing the prohibitions mentioned in Clauses (4) of Article (137) of this Decree-Law. g. Committing a violation that requires the Temporary Closure of the Contractual Company for Research and Development, 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 Contractual Company for Research and Development 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 must be referred to the EDE Pharmaceutical Practices Control Committee or the committee referred to in Clause (2) of Article (160) of this Decree-Law, as the case may be, within (7) seven working days from the date of temporarily suspending the license or Precautionary closure to consider and decide on disciplinary responsibility, within a period not exceeding (10) ten working days from the date the matter is referred to it.
Interpretation and application must be checked against the official text and current version.